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 9 of 16
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K051018 | INTERMEZZO IMPLANT SYSTEMS | Megagen Co., Ltd. | 2005-09-02 | Traditional | PDF ↗ |
| K051507 | MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEM | Blue Sky Bio, LLC | 2005-09-02 | Traditional | PDF ↗ |
| K051576 | AVANA DENTAL IMPLANT SYSTEM | Osstem Co., Ltd. | 2005-09-01 | Traditional | PDF ↗ |
| K050635 | ALLFIM IMPLANT SYSTEMS | Cowellmedi Co., Ltd. | 2005-07-28 | Traditional | PDF ↗ |
| K051502 | SPI DENTAL IMPLANT | Thommen Medical AG | 2005-06-21 | Special | PDF ↗ |
| K050478 | MEDICON IMF-ORION SCREWS | Medicon EG | 2005-06-15 | Traditional | PDF ↗ |
| K051189 | PREVAIL DENTAL IMPLANTS | Implant Innovations, Inc. | 2005-06-08 | Traditional | PDF ↗ |
| K050406 | NOBELSPEEDY IMPLANTS | Nobel Biocare AB | 2005-06-08 | Traditional | PDF ↗ |
| K050568 | ORLUS MINI SCREW | Ortholution Co., Ltd. | 2005-06-01 | Traditional | PDF ↗ |
| K050705 | TIUNITE IMPLANTS | Nobel Biocare AB | 2005-05-19 | Traditional | PDF ↗ |
| K050393 | THE GUIDED SURGERY CONCEPT | Nobel Biocare AB | 2005-05-04 | Traditional | PDF ↗ |
| K050712 | 4.5.* 6.0MM DENTAL IMPLANT AND 6.0*6.0 MM DENTAL IMPLANT | Bicon, Inc. | 2005-04-22 | Traditional | PDF ↗ |
| K050258 | GROOVY IMPLANTS | Nobel Biocare AB | 2005-04-19 | Traditional | PDF ↗ |
| K050506 | PRIMASOLO ONE-PIECE IMPLANTS & HEALING CAPS | Lifecore Biomedical, Inc. | 2005-04-15 | Abbreviated | PDF ↗ |
| K040757 | SIC PRO | Sic Invent AG | 2005-04-13 | Traditional | PDF ↗ |
| K050408 | BICON ORTHODONTIC IMPLANT SYSTEM | Bicon, Inc. | 2005-04-07 | Traditional | PDF ↗ |
| K043195 | NEO IMPLANT SYSTEM | Neoss, Ltd. | 2005-03-07 | Traditional | PDF ↗ |
| K050257 | LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS) (STERILE) | Mondeal Medical Systems GmbH | 2005-02-07 | Special | PDF ↗ |
| K042971 | TITAN DENTAL IMPLANT SYSTEM | Titan Implants, Inc. | 2005-01-14 | Traditional | PDF ↗ |
| K043226 | ENDURE IMPLANT, MODELS 3508, 4308, 3520, 4320 | Imtec Corp. | 2005-01-13 | Traditional | PDF ↗ |
| K042345 | LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS) | Mondeal Medical Systems GmbH | 2005-01-13 | Abbreviated | PDF ↗ |
| K031568 | BICONITE SURFACE TREATMENT | Bicon, Inc. | 2004-11-23 | Traditional | PDF ↗ |
| K042637 | THE 5.0 X 6.0MM DENTAL IMPLANT | Bicon, Inc. | 2004-11-15 | Traditional | PDF ↗ |
| K042339 | NEOPLANT IMPLANT SYSTEM | Neobiotech Co., Ltd. | 2004-11-02 | Traditional | PDF ↗ |
| K041271 | STERNGOLD 3.25 ERA DENTAL IMPLANT SYSTEM | Sterngold | 2004-10-28 | Abbreviated | PDF ↗ |
| K040170 | FRIADENT PLUS DENTAL IMPLANT SYSTEMS | Friadent GmbH | 2004-10-27 | Traditional | PDF ↗ |
| K041136 | MODIFICATION TO SILHOUETTE IC OR SILHOUETTE; LASER-LOK SURFACE TREATMENT -OPTIONAL SURFACE MODIFICATION TO IMPLANTS | Bio-Lok Intl., Inc. | 2004-10-22 | Traditional | PDF ↗ |
| K041651 | STRYKER LEIBINGER SKELETAL ANCHORING SYSTEM | Stryker Leibinger | 2004-09-30 | Traditional | PDF ↗ |
| K042462 | AMERICAN DENTAL IMPLANT | American Dental Implant Corporation | 2004-09-21 | Traditional | PDF ↗ |
| K042354 | MODIFICATION TO: CRESCO TI IMPLANT CONCEPT | Cresco TI Systems AB | 2004-09-21 | Special | PDF ↗ |
| K042429 | THE PRODIGY SYSTEM DENTAL IMPLANTS | BioHorizons Implant Systems, Inc. | 2004-09-16 | Special | PDF ↗ |
| K042289 | MDI ORTHO | Imtec Corp. | 2004-09-15 | Traditional | PDF ↗ |
| K040143 | MONORAIL | Nats Corp. | 2004-09-13 | Traditional | PDF ↗ |
| K041655 | BIO PLANT SYSTEM (IMPLANTS AND ABUTMENTS) | Cowellmedi Co., Ltd. | 2004-09-08 | Abbreviated | PDF ↗ |
| K041661 | NOBEL BIOCARE ENDOSSEOUS IMPLANTS | Nobel Biocare Uas, Inc. | 2004-08-26 | Traditional | PDF ↗ |
| K041509 | ANKYLOS DENTAL IMPLANT SYSTEM | Friadent GmbH | 2004-08-26 | Traditional | PDF ↗ |
| K041876 | NOBELDIRECT OD IMPLANT | Nobel Biocare Uas, Inc. | 2004-08-20 | Traditional | PDF ↗ |
| K041527 | AARHUS ANCHORAGE SYSTEM | Medicon EG | 2004-08-19 | Traditional | PDF ↗ |
| K041492 | ASTRA TECH IMPLANTS - DENTAL SYSTEM | Astra Tech, Inc. | 2004-08-09 | Traditional | PDF ↗ |
| K041368 | DENTIUM CO., LTD. IMPLANTIUM | Dentium Co., Ltd. | 2004-07-29 | Abbreviated | PDF ↗ |
| K041759 | ACE CONNECT INTERNAL CONNECTION | Ace Surgical Supply Co., Inc. | 2004-07-22 | Special | PDF ↗ |
| K041938 | MAXIMUS OS (OVERDENTURE SYSTEM) | BioHorizons Implant Systems, Inc. | 2004-07-22 | Special | PDF ↗ |
| K040946 | ANKYLOS DENTAL IMPLANT SYSTEM | Friadent GmbH | 2004-07-01 | Traditional | PDF ↗ |
| K033984 | STRAUMANN DENTAL IMPLANT SYSTEM | Institut Straumann AG | 2004-06-30 | Traditional | PDF ↗ |
| K041402 | MODIFICATION TO OSSEOTITE NT CERTAIN IMPLANTS | Implant Innovations, Inc. | 2004-06-16 | Special | PDF ↗ |
| K040807 | MIS DENTAL IMPLANT SYSTEM | Mis - Implant Technologies , Ltd. | 2004-06-09 | Traditional | PDF ↗ |
| K040891 | KLS MARTIN ORTHO ANCHORAGE SYSTEM (PLATES) | KLS-Martin L.P. | 2004-05-28 | Traditional | PDF ↗ |
| K040983 | LORENZ SELF-DRILLING IMF SCREW | Walter Lorenz Surgical, Inc. | 2004-05-05 | Special | PDF ↗ |
| K033171 | NSI HEXED AND NON-HEXED IMPLANT SYSTEM AND IMMEDIATE LOADING | Northern Implants, LLC | 2004-04-27 | Traditional | PDF ↗ |
| K033699 | LOCATOR BAR FEMALE, LOCATOR LASER BAR FEMALE, LOCATOR BAR CAST-TO FEMALE, MODELS 08587, 08588, 08586 | Zest Anchors, Inc. | 2004-04-22 | Traditional | PDF ↗ |
| K033630 | MODIFICATION OF: SPHERO FLEX, PIVOT FLEX, AND SPHERO BLOCK | Rhein 83 Srl | 2004-04-21 | Special | PDF ↗ |
| K040714 | HYBRID ENDOPORE ENDOSSEOUS DENTAL IMPLANT | Innova Corp. | 2004-04-09 | Special | PDF ↗ |
| K040643 | BRANEMARK INTEGRATION DENTAL IMPLANT AND ACCESSORIES | Branemark Integration AB | 2004-04-07 | Special | PDF ↗ |
| K034067 | ZTI IMPLANTS SYSTEM, DRM IMPLANTS | Drm Research Laboratories, Inc. | 2004-03-08 | Traditional | PDF ↗ |
| K034014 | SPI CONTACT DENTAL IMPLANT | Thommen Medical AG | 2004-03-05 | Traditional | PDF ↗ |
| K032454 | SILHOUETTE(TM) IC OR SILHOUETTE(TM) & LASER-LOK (TM) | Bio-Lok Intl., Inc. | 2004-03-04 | Traditional | PDF ↗ |
| K033767 | DUAL TOP ANCHOR SYSTEM SCREWS | Jeil Medical Corporation | 2004-02-24 | Traditional | PDF ↗ |
| K030685 | TEETH IN AN HOUR - ARK IMPLANT CONCEPT | Nobel Biocare AB | 2004-02-06 | Traditional | PDF ↗ |
| K034022 | UCLA AND CEMENT-ON ABUTMENTS AND ACCESSORIES | Diamodent | 2004-01-30 | Traditional | PDF ↗ |
| K032263 | 3I PATIENT-SPECIFIC DENTAL ABUTMENT AND OVERDENTURE BAR | Implant Innovations, Inc. | 2004-01-28 | Traditional | PDF ↗ |
| K033483 | KLS-MARTIN ORTHO ANCHORAGE SYSTEM | KLS-Martin L.P. | 2004-01-15 | Traditional | PDF ↗ |
| K031936 | OSTEOMED ORTHODONTIC SCREW SYSTEM | Osteomed LP | 2004-01-07 | Traditional | PDF ↗ |
| K033922 | MODIFICATION TO ITI DENTAL IMPLANT SYSTEM | Institut Straumann AG | 2004-01-07 | Special | PDF ↗ |
| K031322 | INTRA-LOCK HYDROXYAPATITE COATED IMPLANTS | Intra-Lock International | 2003-12-23 | Abbreviated | PDF ↗ |
| K033392 | IMMEDIATE STABILIZING IMPLANT (ISI) | O Co., Inc. | 2003-12-10 | Traditional | PDF ↗ |
| K032774 | RENOVA INTERNAL HEX IMPLANT SYSTEM | Lifecore Biomedical, Inc. | 2003-11-26 | Traditional | PDF ↗ |
| K033430 | 3I TG OSSEOTITE IMPLANT, MODELS TG685, TG610, TG611, TG613, TG5685, TG5610, TG5611, TG5613, TG5615 | Implant Innovations, Inc. | 2003-11-07 | Special | PDF ↗ |
| K032351 | THE MAESTRO SYSTEM 3.0MM DIAMETER IMPLANT | BioHorizons Implant Systems, Inc. | 2003-10-21 | Traditional | PDF ↗ |
| K032302 | XIVE TG ABUTMENTS | Friadent GmbH | 2003-10-02 | Traditional | PDF ↗ |
| K032750 | MODIFICATION TO: XIVE 3.0 DENTAL IMPLANT SYSTEM, MULTIPLE | Friandent GmbH | 2003-10-02 | Special | PDF ↗ |
| K032140 | 5.0 X 5MM ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM | Innova Life Sciences Corp. | 2003-10-02 | Traditional | PDF ↗ |
| K032495 | THE LIFECORE STAGE-1 ANGLED ABUTMENT SYSTEM | Lifecore Biomedical, Inc. | 2003-09-17 | Traditional | PDF ↗ |
| K031632 | OSSEOTITE IOL IMPLANTS AND OSSEOTITE CERTAIN IOL IMPLANTS | Implant Innovations, Inc. | 2003-09-16 | Traditional | PDF ↗ |
| K030614 | 3I DENTAL IMPLANTS | Implant Innovations, Inc. | 2003-09-15 | Traditional | PDF ↗ |
| K022258 | B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. DENTAL IMPLANT SYSTEM | B.T.I. Biotechnology Institute, Sl. | 2003-09-11 | Traditional | PDF ↗ |
| K012681 | ANKYLOS | Dentsply Ceramco | 2003-08-22 | Traditional | PDF ↗ |
| K032158 | XIVE DENTAL IMPLANT SYSTEM MULTIPLE | Friadent GmbH | 2003-08-14 | Special | PDF ↗ |
| K031674 | MODIFICATION TO FRIALIT-2 DENTAL IMPLANT SYSTEM | Friadent GmbH | 2003-08-14 | Special | PDF ↗ |
| K032284 | XIVE TG DENTAL IMPLANT SYSTEM | Friadent GmbH | 2003-08-14 | Special | PDF ↗ |
| K031106 | IMTEC SENDAX MDI AND MDI PLUS ENDOSSEOUS IMPLANT, MODELS OB-XX, SH-XX, MOB-22, MSH-XX | Imtec Corp. | 2003-08-12 | Traditional | PDF ↗ |
| K030639 | XIVE 3.0 DENTAL IMPLANT SYSTEM | Friandent GmbH | 2003-08-12 | Traditional | PDF ↗ |
| K031475 | OSSEOTITE NT CERTAIN IMPLANTS | Implant Innovations, Inc. | 2003-07-28 | Traditional | PDF ↗ |
| K031345 | NOBEL DIRECT, MODELS 30937, 30938 | Nobel Biocare Uas, Inc. | 2003-07-24 | Traditional | PDF ↗ |
| K031055 | ITI DENTAL IMPLANT SYSTEM | Straumann USA | 2003-07-07 | Traditional | PDF ↗ |
| K024111 | ASTRA TECH IMPLANTS-DENTAL SYSTEM FIXTURE OSSEOSPEED | Astra Tech, Inc. | 2003-06-10 | Traditional | PDF ↗ |
| K030243 | ENDURE IMPLANT, MODEL 3508,3511,3514,4308,4311,4314 | Imtec Corp. | 2003-04-23 | Traditional | PDF ↗ |
| K030007 | ITI DENTAL IMPLANT SYSTEM | Straumann USA | 2003-03-31 | Traditional | PDF ↗ |
| K030689 | SPI ELEMENT DENTAL IMPLANT O 3.5 MM | Thommen Medical AG | 2003-03-26 | Special | PDF ↗ |
| K024004 | XIVE TRANSGINGIVAL DENTAL IMPLANT SYSTEM | Friadent GmbH | 2003-03-03 | Special | PDF ↗ |
| K030463 | MODIFICATION TO THE MAESTRO SYSTEM | BioHorizons Implant Systems, Inc. | 2003-02-26 | Special | PDF ↗ |
| K024044 | SABER TECH IMPLANTS SYSTEM | Imtec Corp. | 2003-02-21 | Traditional | PDF ↗ |
| K030257 | NOBEL PERFECT IMPLANT SYSTEM | Nobel Biocare Uas, Inc. | 2003-02-10 | Special | PDF ↗ |
| K023705 | BICON TRANSITIONAL IMPLANT (BTI) SYSTEM | Bicon, Inc. | 2003-01-29 | Traditional | PDF ↗ |
| K023580 | STERNGOLD ACID ETCH DENTAL IMPLANT SYSTEM | Sterngold | 2003-01-17 | Abbreviated | PDF ↗ |
| K023952 | REPLACE ONE PIECE IMPLANT, HA, REPLACE ONE PIECE IMPLANT, TIUNITE | Nobel Biocare Uas, Inc. | 2003-01-16 | Traditional | PDF ↗ |
| K022009 | 3I IMPLANTS; OSSEOTITE DENTAL IMPLANTS; OSSEOTITE NT DENTAL IMPLANTS | Implant Innovations, Inc. | 2002-12-30 | Traditional | PDF ↗ |
| K010185 | 6.0 X 5.7MM DENTAL IMPLANT | Bicon, Inc. | 2002-12-30 | Traditional | PDF ↗ |
| K021915 | TRANSITIONAL IMPLANTS | Intra-Lock International | 2002-12-19 | Abbreviated | PDF ↗ |
| K023067 | IMTEC SENDAX MDI ORTHO6 AND ORTHO8 | Imtec Corp. | 2002-12-03 | Traditional | PDF ↗ |
| K014050 | HEX-LOCK TEMPORARY ABUTMENT | Sulzer Dental, Inc. | 2002-11-13 | Traditional | PDF ↗ |
Product code DZE · Class II · Dental. Data: openFDA.