FDA Product Code
FDA Product Code DZE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.3640
510(k) Clearances — 1,549 records · page 2 of 16
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K230108 | Straumann® BLC and TLC Implants | Institut Straumann AG | 2023-09-14 | Traditional | PDF ↗ |
| K222946 | Oneday Mini Implant System | Oneday Biotech Co., Ltd. | 2023-08-23 | Traditional | PDF ↗ |
| K223924 | LW Implant System | Ossvis Co., Ltd. | 2023-08-08 | Traditional | PDF ↗ |
| K230630 | ZENEX Implant System_Narrow | Izenimplant Co., Ltd. | 2023-07-31 | Traditional | PDF ↗ |
| K223339 | Bone Chamber Implant | Megagen Implant Co., Ltd. | 2023-07-18 | Traditional | PDF ↗ |
| K222707 | IH Implant System | Sewonmedix, Inc. | 2023-07-07 | Traditional | PDF ↗ |
| K230725 | NB Implant System | Arum Dentistry Co., Ltd. | 2023-07-01 | Traditional | PDF ↗ |
| K221488 | Z7 Zirconia Implant System | Z7, LLC | 2023-06-26 | Traditional | PDF ↗ |
| K222142 | BR SLA Type Implant System | Biotem Co., Ltd. | 2023-06-24 | Traditional | PDF ↗ |
| K223638 | Neodent Implant System - Helix Short Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2023-06-23 | Traditional | PDF ↗ |
| K223083 | Straumann SLActive labeling changes | Institut Straumann AG | 2023-06-22 | Traditional | PDF ↗ |
| K222144 | IR SLA Type Implant System | Biotem Co., Ltd. | 2023-06-14 | Traditional | PDF ↗ |
| K222792 | SNUCONE Tissue Level Implant System | Snucone Co., Ltd. | 2023-06-08 | Traditional | PDF ↗ |
| K221752 | Stella | Shinhung Mst Co., Ltd. | 2023-06-04 | Traditional | PDF ↗ |
| K223814 | Genesis ACTIVE Implant System | Keystone Dental, Inc. | 2023-05-25 | Traditional | PDF ↗ |
| K222738 | Point implant system | Pointnix Co., Ltd. | 2023-04-13 | Traditional | PDF ↗ |
| K222457 | Provata Implant System | Southern Implants (Pty), Ltd. | 2023-03-06 | Traditional | PDF ↗ |
| K222211 | Implant Direct Dental Implant Systems Portfolio - MR Conditional | Implant Direct Sybron Manufacturing, LLC | 2023-02-02 | Traditional | PDF ↗ |
| K221317 | S-Mono | Shinhung Mst Co., Ltd. | 2023-01-13 | Traditional | PDF ↗ |
| K211812 | BLUEDIAMOND IMPLANT, Abutment Screw | Megagen Implant Co., Ltd. | 2023-01-06 | Traditional | PDF ↗ |
| K220517 | IBS System | Innobiosurg Co., Ltd. | 2022-12-20 | Traditional | PDF ↗ |
| K213677 | Bonafix 2 Plus | Zentek Medical, LLC | 2022-12-20 | Traditional | PDF ↗ |
| K221453 | S.I.N. Dental Implant System | S.I.N. Sistema DE Implante Nacional S.A. | 2022-12-15 | Traditional | PDF ↗ |
| K220079 | Magicore Narrow System | Innobiosurg Co., Ltd. | 2022-12-14 | Traditional | PDF ↗ |
| K221910 | QRS Dental Implants System | Qrs Medical , Ltd. | 2022-12-14 | Traditional | PDF ↗ |
| K221094 | OmniTaper EV Dental Implants, DS Implants abutments with EV connection | Dentsply Sirona | 2022-11-16 | Traditional | PDF ↗ |
| K220841 | PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS) | Dentsply Sirona | 2022-11-16 | Traditional | PDF ↗ |
| K222497 | Zaga Zygomatic System | Southern Implants (Pty), Ltd. | 2022-11-09 | Traditional | PDF ↗ |
| K222231 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | 2022-10-27 | Traditional | PDF ↗ |
| K211409 | Proximerge 2 Dental Implant System | Quadric Biomed, LLC | 2022-10-19 | Traditional | PDF ↗ |
| K212702 | IM/ST Fixture System | Guilin Fiteeth Medical Instrument Co., Ltd. | 2022-10-13 | Traditional | PDF ↗ |
| K222131 | NB 1 SA Implant System | Arum Dentistry Co., Ltd. | 2022-09-19 | Special | PDF ↗ |
| K220978 | TSX Implants | Biomet 3i, LLC | 2022-09-14 | Traditional | PDF ↗ |
| K220251 | Neodent Implant System - GM Narrow Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2022-09-06 | Traditional | PDF ↗ |
| K212364 | BLT Dental Implant System | Bio Concept Co., Ltd. | 2022-08-10 | Traditional | PDF ↗ |
| K211952 | BTI Interna Narrow/Plus Dental Implant System UnicCa | B.T.I. Biotechnology Institute, Sl. | 2022-07-21 | Traditional | PDF ↗ |
| K213997 | Kontact Dental Implant System | Biotech Dental, Sas | 2022-07-15 | Traditional | PDF ↗ |
| K213576 | Tatum Surgical Dental Implant System | Suncoast Dental, Inc. Dba Tatum Surgical | 2022-07-15 | Traditional | PDF ↗ |
| K210354 | SNUCONE Bone Level Implant System | Snucone Co., Ltd. | 2022-07-13 | Traditional | PDF ↗ |
| K212775 | Adin Short Implants | Adin Dental Implants Systems , Ltd. | 2022-07-08 | Traditional | PDF ↗ |
| K212785 | Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments | Blue Sky Bio, LLC | 2022-06-30 | Traditional | PDF ↗ |
| K210852 | Noris Medical Dental Implants System - Cortical | Noris Medical , Ltd. | 2022-06-24 | Traditional | PDF ↗ |
| K220200 | Paltop Conical Implant System | Paltop Advanced Dental Solutions, Ltd. | 2022-05-25 | Traditional | PDF ↗ |
| K211090 | ZENEX Implant System | Izenimplant Co., Ltd. | 2022-04-13 | Traditional | PDF ↗ |
| K213506 | NB 1 SA Implant System | Arum Dentistry Co., Ltd. | 2022-04-06 | Traditional | PDF ↗ |
| K220022 | TRATE Dental Implant System | Trate AG | 2022-04-04 | Traditional | PDF ↗ |
| K213672 | T3 Pro Implants | Biomet 3i, LLC | 2022-03-28 | Traditional | PDF ↗ |
| K210489 | SICtapered & SICvantage tapered | Sic Invent AG | 2022-03-17 | Traditional | PDF ↗ |
| K202046 | LOTA SLA Dental Implant System and LOTA HA Dental Implant System | Kj Meditech Co., Ltd. | 2022-03-01 | Traditional | PDF ↗ |
| K213599 | SuperLine | Dentium Co., Ltd. | 2022-02-23 | Traditional | PDF ↗ |
| K212533 | BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants | Institut Straumann AG | 2022-01-28 | Traditional | PDF ↗ |
| K203360 | EK Implants and Abutments System | Hiossen, Inc. | 2022-01-07 | Traditional | PDF ↗ |
| K210039 | CORE1 Implant System | Cybermed, Inc. | 2022-01-07 | Traditional | PDF ↗ |
| K211978 | Jplant | Jj Medical Co., Ltd. | 2022-01-05 | Traditional | PDF ↗ |
| K203660 | TRI-matrix Implant Line | Tri Dental Implants Int. AG | 2021-12-21 | Traditional | PDF ↗ |
| K211109 | N1 TiUltra TCC Implant System | Nobel Biocare Services AG | 2021-12-21 | Traditional | PDF ↗ |
| K212538 | DESS Dental Implants | Terrats Medical SL | 2021-12-14 | Traditional | PDF ↗ |
| K210117 | Paltop Narrow Implant | Paltop Advanced Dental Solutions, Ltd. | 2021-11-30 | Traditional | PDF ↗ |
| K210499 | Alpha Dent Implants Dental Implants System | Alpha Dent Implants GmbH | 2021-11-01 | Traditional | PDF ↗ |
| K211921 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | 2021-10-20 | Traditional | PDF ↗ |
| K212517 | Magicore System | Innobiosurg Co., Ltd. | 2021-10-15 | Special | PDF ↗ |
| K210523 | Implanova | Dental Evolutions, Inc. | 2021-09-30 | Traditional | PDF ↗ |
| K212125 | Nobel Biocare Dental Implant Systems Portfolio - MR Conditional | Nobel Biocare AG | 2021-09-24 | Traditional | PDF ↗ |
| K202092 | ABC Dental Implant System | Abracadabra Implants , Ltd. | 2021-09-23 | Traditional | PDF ↗ |
| K203554 | AnyOne External Implant System | Megagen Implant Co., Ltd. | 2021-08-28 | Traditional | PDF ↗ |
| K210610 | PrimeTaper EV Dental Implant | Dentsply Sirona, Inc. | 2021-08-27 | Traditional | PDF ↗ |
| K210336 | Neodent Implant System - Zirconia Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2021-08-13 | Traditional | PDF ↗ |
| K202825 | BTI Extra-Short Dental Implant System UnicCa | B.T.I. Biotechnology Institute, Sl. | 2021-07-29 | Traditional | PDF ↗ |
| K211052 | Straumann RidgeFit Implants | Institut Straumann AG | 2021-07-08 | Traditional | PDF ↗ |
| K203309 | NUVO CF Implant System | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2021-07-06 | Traditional | PDF ↗ |
| K203725 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | 2021-06-23 | Traditional | PDF ↗ |
| K210161 | AnyOne Onestage Implant System | Megagen Implant Co., Ltd. | 2021-06-22 | Traditional | PDF ↗ |
| K210855 | Straumann BLX Implant System | Institut Straumann AG | 2021-06-21 | Traditional | PDF ↗ |
| K210220 | Kontact Dental Implant System | Biotech Dental, Sas | 2021-06-18 | Traditional | PDF ↗ |
| K210886 | MIS Lance+ Conical Connection Dental Implant System | Dentsply Sirona | 2021-06-17 | Traditional | PDF ↗ |
| K210080 | Dentis s-Clean s-Line Mini | Dentis Co., Ltd. | 2021-06-04 | Traditional | PDF ↗ |
| K202832 | Implacil Implant System | Implacil DE Bortoli Material Odontologico Ltda | 2021-05-26 | Traditional | PDF ↗ |
| K200573 | BoneTrust Mini Implant System | Medical Instinct Deutschland GmbH | 2021-05-14 | Abbreviated | PDF ↗ |
| K200329 | IDCAM Dental Implants | Implants Diffusion International | 2021-04-22 | Traditional | PDF ↗ |
| K210134 | Dentis s-Clean s-Line | Dentis Co., Ltd. | 2021-04-19 | Traditional | PDF ↗ |
| K203701 | Locator Overdenture Implant System | Ivory Super Holdco Inc. / Zest Anchors, LLC | 2021-04-15 | Traditional | PDF ↗ |
| K202773 | s-Clean SQ-SL Implant System Mini | Dentis Co., Ltd. | 2021-03-18 | Traditional | PDF ↗ |
| K203382 | Neodent Implant System-Easy Pack | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2021-03-15 | Traditional | PDF ↗ |
| K210132 | s-Clean SQ-SL Implant System Regular | Dentis Co., Ltd. | 2021-02-17 | Special | PDF ↗ |
| K192839 | DSP Implant System | D.S.P Industrial Eireli | 2021-02-11 | Traditional | PDF ↗ |
| K202942 | Straumann 4 mm Short Implants | Straumann USA, LLC | 2021-02-08 | Traditional | PDF ↗ |
| K201553 | Simply Iconic Implants | Implant Direct Sybron Manufacturing, LLC | 2021-01-22 | Traditional | PDF ↗ |
| K201700 | BEGO Semados® RS/RSX Implant System | Bego Implant Systems GmbH & Co. KG | 2021-01-13 | Traditional | PDF ↗ |
| K201491 | Neodent Implant System - Zirconia Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2020-12-22 | Traditional | PDF ↗ |
| K201712 | Z5-TL | Z-Systems AG | 2020-12-01 | Traditional | PDF ↗ |
| K200992 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | 2020-11-17 | Traditional | PDF ↗ |
| K202344 | TiUltra Implants and Xeal Abutments | Nobel Biocare AB | 2020-11-16 | Traditional | PDF ↗ |
| K183044 | JTK Dental Implant System | Jiangyin Jintech Biotech Co., Ltd. | 2020-11-10 | Traditional | PDF ↗ |
| K181477 | MS Lide Implant Systems | Hangzhou Minsheng Lide Medical Science & Technology Co., Ltd. | 2020-10-20 | Traditional | PDF ↗ |
| K200906 | MINICONE Implant | Medentika GmbH | 2020-10-16 | Traditional | PDF ↗ |
| K200386 | Z5-BL | Z-Systems AG | 2020-10-14 | Traditional | PDF ↗ |
| K200817 | URIS OMNI Narrow System & Prosthetic | Truabutment, Inc. | 2020-10-07 | Traditional | PDF ↗ |
| K193401 | Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE Implants | Altatec GmbH | 2020-09-29 | Traditional | PDF ↗ |
| K202039 | Honorst Implant System | Medimecca Co., Ltd. | 2020-09-25 | Special | PDF ↗ |
| K202479 | IBS Implant System | Innobiosurg Co., Ltd. | 2020-09-23 | Special | PDF ↗ |
Product code DZE · Class II · Dental. Data: openFDA.