Implant, Endosseous, Root-Form
Regulation 872.3640
19510(k)s in 12 months (1,550 all time)
2recalls in 12 months (212 all time)
192recalls that name a 510(k)
Top companies in DZE
| Company | 510(k)s | Recalls |
|---|---|---|
| Nobel Biocare AB | 33 | 37 |
| Biomet 3i | 11 | 52 |
| Nobelpharma AB | 52 | 0 |
| Zimmer Dental, Inc. | 19 | 30 |
| Straumann USA | 35 | 9 |
| Implant Innovations, Inc. | 37 | 4 |
| Steri-Oss, Inc. | 40 | 0 |
| BioHorizons Implant Systems, Inc. | 26 | 12 |
| Minimatic Implant Technology | 34 | 0 |
| Implant Center of the Palm Beaches | 32 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 13, 2002 | K014050 | HEX-LOCK TEMPORARY ABUTMENT Sulzer Dental, Inc. | DZE |
| Oct 11, 2002 | K022562 | VARIOUS BRANEMARK SYSTEM IMPLANTS-IMMEDIATE FUNCTION INDICATION Nobel Biocare AB | DZE |
| Oct 9, 2002 | K023336 | OCO DENTAL IMPLANT (5.0MM DIAMETER) O Co., Inc. | DZE |
| Sep 27, 2002 | K022424 | REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132 & 60162 Nobel Biocare Uas, Inc. | DZE |
| Sep 26, 2002 | K023113 | REPLACE TIUNITE ENDOSSEOUS IMPLANT Nobel Biocare Uas, Inc. | DZE |
| Sep 20, 2002 | K022912 | POST AND CORE - THIN FOR THE BASIC DENTAL IMPLANT SYSTEM Basic Dental Implant Systems, Inc. | DZE |
| Sep 19, 2002 | K022859 | ABUTMENT AND PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM Straumann USA | DZE |
| Sep 19, 2002 | K022113 | 3I DENTAL IMPLANT ACCESSORIES Implant Innovations, Inc. | DZE |
| Sep 11, 2002 | K012473 | VIDENT HEXTOP, SYNOCTA IN-CERAM BLANK/COPING MANUFACTURED BY VIDENT Vident | DZE |
| Aug 30, 2002 | K021355 | ENDOSSEOUS IMPLANT Branemark Integration AB, SE | DZE |
| Aug 27, 2002 | K011879 | 3A DENTAL IMPLANT SYSTEM Osseco Biosource, Ltd. | DZE |
| Aug 14, 2002 | K022425 | SCREWLINE Altatec Biotechnologies N.A., Inc. | DZE |
| Jul 24, 2002 | K021322 | ENDOSSOUS IMPLANTS Intra-Lock International | DZE |
| Jul 15, 2002 | K022038 | SPI ONETIME DENTAL IMPLANT Paxmed International | DZE |
| Jul 2, 2002 | K021318 | XIVE DENTAL IMPLANT SYSTEM Friadent GmbH | DZE |
| Jun 26, 2002 | K021045 | ERA IMPLANT Sterngold | DZE |
| Jun 10, 2002 | K021833 | MODIFICATION TO BLUE SKY DENTAL IMPLANT SYSTEM Blue Sky Bio | DZE |
| Jun 5, 2002 | K021584 | REPLACE SCALLOPED MARGIN IMPLANT SYSTEM Nobel Biocare Uas, Inc. | DZE |
| Jun 4, 2002 | K010132 | KLOCKNER DENTAL IMPLANTS, MODELS SK, NK, IK, S3, AND S4 SOADCO, S.L., AD | DZE |
| May 29, 2002 | K020646 | REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132, & 60162 Nobel Biocare Uas, Inc. | DZE |
| May 16, 2002 | K014235 | OSSEOTITE NT DENTAL IMPLANTS & ACCESSORIES Implant Innovations, Inc. | DZE |
| May 10, 2002 | K020617 | NSI HEXED AND NON-HEXED IMPLANT SYSTEM Nsi | DZE |
| May 3, 2002 | K021244 | ACE HA SCREW DENTAL IMPLANT SYSTEM Ace Surgical Supply Co., Inc. | DZE |
| Apr 10, 2002 | K011524 | IMMEDIATE STABILIZING DEVICE (ISD) O Co., Inc. | DZE |
| Apr 9, 2002 | K013067 | FRIALOC DENTAL IMPLANT SYSTEM Friadent GmbH | DZE |
| Mar 19, 2002 | K014214 | SULZER DENTAL CERAMIC SYSTEM-SPLINE Sulzer Dental, Inc. | DZE |
| Mar 15, 2002 | K020645 | MODIFICATION TO THE MAESTRO SYSTEM BioHorizons Implant Systems, Inc. | DZE |
| Mar 15, 2002 | K013867 | XIVE DENTAL IMPLANT SYSTEM Friadent GmbH | DZE |
| Mar 8, 2002 | K020391 | STERN MICRO ERA ATTACHMENT SYSTEM Sterngold | DZE |
| Mar 4, 2002 | K001638 | O-RING PROSTHETIC ATTACHMENT Titan Implants | DZE |
| Feb 8, 2002 | K020096 | ESTHETIC EASE ABUTMENTS FOR THE ITI DENTAL IMPLANT SYSTEM Institut Straumann AG | DZE |
| Feb 5, 2002 | K013891 | SYNOCTA ANGLED ABUTMENTS FOR THE ITI WIDE NECK IMPLANT Institut Straumann AG | DZE |
| Jan 25, 2002 | K020133 | MODIFICATION TO THE MAESTRO SYSTEM BioHorizons Implant Systems, Inc. | DZE |
| Jan 18, 2002 | K013494 | 3.75MM AND 5.0MM SPLINE TWIST IMPLANT Sulzer Dental, Inc. | DZE |
| Jan 10, 2002 | K013383 | BIOHEX ONE-PIECE ONE STAGE DENTAL IMPLANT SYSTEM Biomedical Implant Technology, Inc., CA | DZE |
| Dec 20, 2001 | K013438 | FRIALIT-2 ESTHETICBASE ABUTMENT Friadent GmbH | DZE |
| Dec 19, 2001 | K013798 | PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM Institut Straumann AG | DZE |
| Dec 18, 2001 | K981052 | CRESCO TI IMPLANT CONCEPT Cresco TI Systems AB | DZE |
| Dec 17, 2001 | K013570 | OSSEOTITE DENTAL IMPLANTS Implant Innovations, Inc. | DZE |
| Nov 28, 2001 | K013682 | MODIFICATION TO BASIC DENTAL IMPLANT SYSTEM Basic Dental Implant Systems, Inc. | DZE |
| Nov 19, 2001 | K013227 | SCREW VENT IMPLANT; TAPERED SCREW VENT IMPLANT Sulzer Dental, Inc. | DZE |
| Oct 22, 2001 | K011502 | CRYSTAL AND CRYSTAL-CARE IMPLANTS SYSTEM Crystal-Seal Dental Implants | DZE |
| Sep 28, 2001 | K012911 | 3I LOCATER ABUTMENT SYSTEM Implant Innovations, Inc. | DZE |
| Sep 28, 2001 | K011574 | UNIPLANT DENTAL IMPLANT SYSTEM Universal Implant Systems, Inc. | DZE |
| Sep 28, 2001 | K010882 | BLUE SKY BIO DENTAL IMPLANT SYSTEM Blue Sky Bio | DZE |
| Sep 28, 2001 | K010619 | UCLA AND UNIVERSAL ABUTMENTS Diamodent | DZE |
| Sep 28, 2001 | K010467 | UNIVERSAL DENTAL COPING (UDC) Paxmed International | DZE |
| Sep 28, 2001 | K003191 | MIS IMPLANT SYSTEM DECIVE Mis Implants Technologies , Ltd., IL | DZE |
| Sep 28, 2001 | K000035 | OMNICARE DENTAL IMPLANT SYSTEM Omnicare Dental Implant Center | DZE |
| Sep 20, 2001 | K991250 | QUANTUM VERSATILITY IMPLANT SYSTEM Quantum Bioengineering, Ltd. | DZE |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.