Review Panel
Dental FDA 510(k) Clearances & Devices
- Cleared Devices
- 12,679
- Product Codes (page)
- 33
- Latest Decision
- 2022-03-28
Clearances · page 12 of 127
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K213672 | T3 Pro Implants | Biomet 3i, LLC | DZE | Class II | 2022-03-28 |
| K213965 | BeautiBond Xtreme | Shofu Dental Corporation | KLE | Class II | 2022-03-18 |
| K212939 | Vintage Prime Press | Shofu Dental Corporation | EIH | Class II | 2022-03-18 |
| K210489 | SICtapered & SICvantage tapered | Sic Invent AG | DZE | Class II | 2022-03-17 |
| K220726 | K Clear | Kline Europe GmbH | NXC | Class II | 2022-03-16 |
| K212628 | DESS Dental Smart Solutions | Terrats Medical SL | NHA | Class II | 2022-03-11 |
| K202075 | Dental Electric Motor | Foshan Cicada Dental Instrument Co, Ltd. | EBW | Class I | 2022-03-11 |
| K220422 | Dental sensors NanoPix1, NanoPix2 | Iray Technology Taicang , Ltd. | MUH | Class II | 2022-03-11 |
| K214071 | Hexa-Temp | Spident Co., Ltd. | EBG | Class II | 2022-03-10 |
| K202675 | InRoad® Dental Synthetic Bone Graft | Osteogene Tech Corp | LYC | Class II | 2022-03-04 |
| K213994 | Flexible Block | Shandong Huge Dental Material Corporation | EBI | Class II | 2022-03-04 |
| K212676 | Osteon Precision Milled Suprastructure | Implant Solutions Pty Ltd (Osteon Medical) | NHA | Class II | 2022-03-03 |
| K214091 | Dental Image Plate Scanner, Model DFC-4T-SMART | Hefei Dentafilm Medical Equipment Co., Ltd. | MUH | Class II | 2022-03-02 |
| K213932 | A-dec 300, A-dec 500 | A-Dec, Inc. | EIA | Class I | 2022-03-02 |
| K202046 | LOTA SLA Dental Implant System and LOTA HA Dental Implant System | Kj Meditech Co., Ltd. | DZE | Class II | 2022-03-01 |
| K211510 | uLab Systems Dental Aligner Kit | Ulab Systems, Inc. | NXC | Class II | 2022-02-24 |
| K213599 | SuperLine | Dentium Co., Ltd. | DZE | Class II | 2022-02-23 |
| K213392 | INLIANT Surgical Navigation System | Navigate Surgical Technologies, Inc. | PLV | Class II | 2022-02-22 |
| K220471 | VALO X, VALO X Accessory Lenses | Ultradent Products, Inc. | EBZ | Class II | 2022-02-22 |
| K214005 | Zirconia Dental Ceramics | Shenzhen Yurucheng Dental Materials Co., Ltd. | EIH | Class II | 2022-02-18 |
| K214003 | Dental Zirconia Pre-shaded Block | Shenzhen Yurucheng Dental Materials Co., Ltd. | EIH | Class II | 2022-02-18 |
| K220277 | Digital Intraoral X-ray Sensor | Shenzhen Xpectvision Technology Co., Ltd. | MUH | Class II | 2022-02-17 |
| K220419 | Apapro Desensitizer | Sangi Co., Ltd. | LBH | Class II | 2022-02-16 |
| K210636 | Morpheus | S4S UK , Ltd. | LRK | Class II | 2022-02-15 |
| K212570 | OsteoPlan System | Osteomed, LLC | DZJ | Class II | 2022-02-11 |
| K213890 | IMICRYL Impression Materials | Imicryl Dis Malzemeleri San. VE Tic. A.S. | ELW | Class II | 2022-02-11 |
| K213297 | Redline | Johns Dental Laboratories | NXC | Class II | 2022-02-09 |
| K201191 | ELEC-LED | Micro-Nx Co., Ltd. | EBW | Class I | 2022-02-07 |
| K210356 | Noris Medical Dental Implants System | Noris Medical , Ltd. | NHA | Class II | 2022-02-04 |
| K213777 | Stryker Resorbable Fixation System | Stryker Leibinger Micro Implants | JEY | Class II | 2022-02-04 |
| K210826 | Healing Abutment, Cover Screw | Megagen Implant Co., Ltd. | NHA | Class II | 2022-02-03 |
| K210832 | EVOCLEAN CLEANsert Ultrasonic Insert | Ttbio Corp. | ELC | Class II | 2022-02-02 |
| K211701 | X-Guide® Surgical Navigation System | X-Nav Technologies, LLC | QRY | Class II | 2022-02-01 |
| K220257 | Permadyne | 3M Deutschland GmbH | ELW | Class II | 2022-02-01 |
| K213401 | DIAPLUS Universal | DiaDent Group International | KLE | Class II | 2022-01-31 |
| K213093 | STEP-1 PumEtch | Rounding Third, LLC | KLE | Class II | 2022-01-28 |
| K212533 | BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants | Institut Straumann AG | DZE | Class II | 2022-01-28 |
| K213475 | Elevo Snoring Intervention Set | Zelegent, Inc. | LRK | Class II | 2022-01-27 |
| K212173 | HDH Treatment Planning System | Cdb Corporation | PNN | Class II | 2022-01-25 |
| K201323 | INNO SLA Submerged Implant System | Cowellmedi Co., Ltd. | NHA | Class II | 2022-01-25 |
| K213343 | Saremco Print CROWNTEC | Saremco Dental AG | EBF | Class II | 2022-01-21 |
| K210259 | Parkell Self-Adhesive Cement | Parkell, Inc. | EMA | Class II | 2022-01-20 |
| K203072 | Franz Zirconia Dental Crown | Franz Biotech, Inc. | ELL | Class II | 2022-01-19 |
| K212772 | Precision Align | Precision Align, LLC | NXC | Class II | 2022-01-15 |
| K213643 | UltraPrint-Dental Temp C&B UV | Guangzhou Heygears IMC., Inc. | EBG | Class II | 2022-01-14 |
| K220097 | PRESIDENT The Original | Coltène/Whaledent AG | ELW | Class II | 2022-01-13 |
| K203706 | Dental Electric Motor | Guilin Woodpecker Medical Instrument Co., Ltd. | EBW | Class I | 2022-01-13 |
| K213391 | High Retention Attachment System | Zest Anchors, LLC | NHA | Class II | 2022-01-11 |
| K212541 | 3Delta Denture Base - 3Delta Denture Bond - 3Delta Denture Fix | Deltamed GmbH | EBI | Class II | 2022-01-10 |
| K203360 | EK Implants and Abutments System | Hiossen, Inc. | DZE | Class II | 2022-01-07 |
| K213570 | Dental Zirconia Ceramic | Aidite (Qinhuangdao) Technology Co., Ltd. | EIH | Class II | 2022-01-07 |
| K210039 | CORE1 Implant System | Cybermed, Inc. | DZE | Class II | 2022-01-07 |
| K211978 | Jplant | Jj Medical Co., Ltd. | DZE | Class II | 2022-01-05 |
| K210711 | Neocis Guidance System (NGS) with Yomi Plan v2.0.1 | Neocis, Inc. | PLV | Class II | 2021-12-22 |
| K213159 | Encore System | Siesta Medical, Inc. | ORY | Class II | 2021-12-22 |
| K211109 | N1 TiUltra TCC Implant System | Nobel Biocare Services AG | DZE | Class II | 2021-12-21 |
| K213139 | SURGmatic S15 L Pro | Kavo Dental GmbH | EGS | Class I | 2021-12-21 |
| K203660 | TRI-matrix Implant Line | Tri Dental Implants Int. AG | DZE | Class II | 2021-12-21 |
| K212770 | Vision | Softsmile, Inc. | PNN | Class II | 2021-12-21 |
| K212730 | BellaTek Encode Emergence Healing Abutments | Biomet 3i, LLC | NHA | Class II | 2021-12-21 |
| K210559 | ATOZ Mini-Screw | Mk Meditech, Inc. | OAT | Class II | 2021-12-19 |
| K211531 | Cordless Prophy System, Model: i-Polish | Guilin Woodpecker Medical Instrument Co., Ltd. | EKX | Class I | 2021-12-17 |
| K213916 | ArchForm Orthodontic Software System | Archform, Inc. | PNN | Class II | 2021-12-16 |
| K212538 | DESS Dental Implants | Terrats Medical SL | DZE | Class II | 2021-12-14 |
| K212577 | DESS Dental Smart Solutions | Terrats Medical SL | NHA | Class II | 2021-12-10 |
| K213637 | JAZZ Solo sensor | Jazz Imaging, LLC Dba Jazz Imaging | MUH | Class II | 2021-12-10 |
| K203615 | Dental Scaler and Air Polisher | Guilin Woodpecker Medical Instrument Co., Ltd. | ELC | Class II | 2021-12-10 |
| K210817 | C&B 5.0 Hybrid | Arum Dentistry Co., Ltd. | EBG | Class II | 2021-12-08 |
| K212983 | Injectable Root Canal Bioceramic Sealer | Beijing C-Root Dental Medical Devices Co., Ltd. | KIF | Class II | 2021-12-08 |
| K211804 | 3Delta Crown | Deltamed GmbH | EBF | Class II | 2021-12-06 |
| K212548 | LUXEN CL Dental Liquid | Dentalmax Co., Ltd. | EIH | Class II | 2021-12-06 |
| K211721 | PS System | Inter-Med, Inc. | NYL | Class I | 2021-12-02 |
| K210117 | Paltop Narrow Implant | Paltop Advanced Dental Solutions, Ltd. | DZE | Class II | 2021-11-30 |
| K212664 | Sherlock | Open Implants, LLC | NHA | Class II | 2021-11-30 |
| K211345 | C-30 Crown Kit | Perfect Fit Crowns, LLC | EBF | Class II | 2021-11-24 |
| K211854 | VITA Akzent LC | Vita Zahnfabrik GmbH H Rauter & CO | EBD | Class II | 2021-11-22 |
| K211871 | FAICO Dental Implant System and CAD/CAM Abutments | Faico Medical, LLC | NHA | Class II | 2021-11-18 |
| K213425 | BruxZir Esthetic | Prismatik Dentalcraft, Inc. | EIH | Class II | 2021-11-17 |
| K213449 | DS Implants abutments provided with the EV connection | Dentsply Sirona | NHA | Class II | 2021-11-15 |
| K212765 | Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Bloomden Bioceramics (HuNan) Co., Ltd. | EIH | Class II | 2021-11-15 |
| K212259 | Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Zirdent New Material Co., Ltd. | EIH | Class II | 2021-11-12 |
| K202371 | Highspeed Airturbine Handpiece | Beijing Dongbo Dental Handpiece Co., Ltd. | EFB | Class I | 2021-11-08 |
| K212496 | Ortho Aligner System | Ortho Lab Services, LLC | NXC | Class II | 2021-11-04 |
| K210473 | Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus) | Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | EMA | Class II | 2021-11-02 |
| K210499 | Alpha Dent Implants Dental Implants System | Alpha Dent Implants GmbH | DZE | Class II | 2021-11-01 |
| K211537 | QuickAligners | Oral Image, Inc. | NXC | Class II | 2021-10-26 |
| K211069 | EndSnorZ Sleep Appliance | Prismatik Dentalcraft, Inc. | LRK | Class II | 2021-10-26 |
| K203808 | Multi-unit Abutment, Multi-unit Angled Abutment | Megagen Implant Co., Ltd. | NHA | Class II | 2021-10-20 |
| K211921 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | DZE | Class II | 2021-10-20 |
| K212517 | Magicore System | Innobiosurg Co., Ltd. | DZE | Class II | 2021-10-15 |
| K211992 | Ortho MI System | Osteonic Co., Ltd. | OAT | Class II | 2021-10-15 |
| K210231 | Vittra APS Unique | Dentscare Ltda | EBF | Class II | 2021-10-14 |
| K211905 | UltraCal XS | Ultradent Products, Inc. | KIF | Class II | 2021-10-13 |
| K203750 | Straumann CARES P-Series CAD/CAM System | Institut Straumann AG | NHA | Class II | 2021-10-09 |
| K203688 | Clear Aligner | Wuxi EA Medical Instruments Technologies Limited. | NXC | Class II | 2021-10-08 |
| K201210 | The Micro Screw System, Micro Screw System Basic | Hager& Meisinger GmbH | DZL | Class II | 2021-10-08 |
| K212279 | Digital Intraoral X-ray Imaging System | Iray Technology Taicang , Ltd. | MUH | Class II | 2021-10-07 |
| K202063 | TrusFIL Universal Composite Restorative | Rizhao Huge Biomaterials Company, Ltd. | EBF | Class II | 2021-10-06 |
| K211308 | INNI-CERA | Aon Co., Ltd. | EIH | Class II | 2021-10-04 |
| K212828 | BRIUS Planner Software | Brius Technologies, Inc. | PNN | Class II | 2021-10-01 |
12,679 clearances in the Dental panel. Data: openFDA.