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 |
|---|---|---|---|
| Sep 9, 2005 | K051614 | PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION PROSTHETICS Lifecore Biomedical, Inc. | DZE |
| Sep 2, 2005 | K051507 | MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEM Blue Sky Bio, LLC | DZE |
| Sep 2, 2005 | K051018 | INTERMEZZO IMPLANT SYSTEMS Megagen Co., Ltd. | DZE |
| Sep 1, 2005 | K051576 | AVANA DENTAL IMPLANT SYSTEM Osstem Co., Ltd. | DZE |
| Jul 28, 2005 | K050635 | ALLFIM IMPLANT SYSTEMS Cowellmedi Co., Ltd. | DZE |
| Jun 21, 2005 | K051502 | SPI DENTAL IMPLANT Thommen Medical AG | DZE |
| Jun 15, 2005 | K050478 | MEDICON IMF-ORION SCREWS Medicon EG, DE | DZE |
| Jun 8, 2005 | K051189 | PREVAIL DENTAL IMPLANTS Implant Innovations, Inc. | DZE |
| Jun 8, 2005 | K050406 | NOBELSPEEDY IMPLANTS Nobel Biocare AB | DZE |
| Jun 1, 2005 | K050568 | ORLUS MINI SCREW Ortholution Co., Ltd. | DZE |
| May 19, 2005 | K050705 | TIUNITE IMPLANTS Nobel Biocare AB | DZE |
| May 4, 2005 | K050393 | THE GUIDED SURGERY CONCEPT Nobel Biocare AB | DZE |
| Apr 22, 2005 | K050712 | 4.5.* 6.0MM DENTAL IMPLANT AND 6.0*6.0 MM DENTAL IMPLANT Bicon, Inc. | DZE |
| Apr 19, 2005 | K050258 | GROOVY IMPLANTS Nobel Biocare AB | DZE |
| Apr 15, 2005 | K050506 | PRIMASOLO ONE-PIECE IMPLANTS & HEALING CAPS Lifecore Biomedical, Inc. | DZE |
| Apr 13, 2005 | K040757 | SIC PRO Sic Invent AG, CH | DZE |
| Apr 7, 2005 | K050408 | BICON ORTHODONTIC IMPLANT SYSTEM Bicon, Inc. | DZE |
| Mar 7, 2005 | K043195 | NEO IMPLANT SYSTEM Neoss, Ltd. | DZE |
| Feb 7, 2005 | K050257 | LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS) (STERILE) Mondeal Medical Systems GmbH, NL | DZE |
| Jan 14, 2005 | K042971 | TITAN DENTAL IMPLANT SYSTEM Titan Implants, Inc. | DZE |
| Jan 13, 2005 | K043226 | ENDURE IMPLANT, MODELS 3508, 4308, 3520, 4320 Imtec Corp. | DZE |
| Jan 13, 2005 | K042345 | LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS) Mondeal Medical Systems GmbH, NL | DZE |
| Nov 23, 2004 | K031568 | BICONITE SURFACE TREATMENT Bicon, Inc. | DZE |
| Nov 15, 2004 | K042637 | THE 5.0 X 6.0MM DENTAL IMPLANT Bicon, Inc. | DZE |
| Nov 2, 2004 | K042339 | NEOPLANT IMPLANT SYSTEM Neobiotech Co., Ltd. | DZE |
| Oct 28, 2004 | K041271 | STERNGOLD 3.25 ERA DENTAL IMPLANT SYSTEM Sterngold | DZE |
| Oct 27, 2004 | K040170 | FRIADENT PLUS DENTAL IMPLANT SYSTEMS Friadent GmbH | DZE |
| Oct 22, 2004 | K041136 | MODIFICATION TO SILHOUETTE IC OR SILHOUETTE; LASER-LOK SURFACE TREATMENT -OPTIONAL SURFACE MODIFICATION TO IMPLANTS Bio-Lok Intl., Inc. | DZE |
| Sep 30, 2004 | K041651 | STRYKER LEIBINGER SKELETAL ANCHORING SYSTEM Stryker Leibinger | DZE |
| Sep 21, 2004 | K042462 | AMERICAN DENTAL IMPLANT American Dental Implant Corporation | DZE |
| Sep 21, 2004 | K042354 | MODIFICATION TO: CRESCO TI IMPLANT CONCEPT Cresco TI Systems AB, SE | DZE |
| Sep 16, 2004 | K042429 | THE PRODIGY SYSTEM DENTAL IMPLANTS BioHorizons Implant Systems, Inc. | DZE |
| Sep 15, 2004 | K042289 | MDI ORTHO Imtec Corp. | DZE |
| Sep 13, 2004 | K040143 | MONORAIL Nats Corp. | DZE |
| Sep 8, 2004 | K041655 | BIO PLANT SYSTEM (IMPLANTS AND ABUTMENTS) Cowellmedi Co., Ltd. | DZE |
| Aug 26, 2004 | K041661 | NOBEL BIOCARE ENDOSSEOUS IMPLANTS Nobel Biocare Uas, Inc. | DZE |
| Aug 26, 2004 | K041509 | ANKYLOS DENTAL IMPLANT SYSTEM Friadent GmbH | DZE |
| Aug 20, 2004 | K041876 | NOBELDIRECT OD IMPLANT Nobel Biocare Uas, Inc. | DZE |
| Aug 19, 2004 | K041527 | AARHUS ANCHORAGE SYSTEM Medicon EG | DZE |
| Aug 9, 2004 | K041492 | ASTRA TECH IMPLANTS - DENTAL SYSTEM Astra Tech, Inc. | DZE |
| Jul 29, 2004 | K041368 | DENTIUM CO., LTD. IMPLANTIUM Dentium Co., Ltd. | DZE |
| Jul 22, 2004 | K041938 | MAXIMUS OS (OVERDENTURE SYSTEM) BioHorizons Implant Systems, Inc. | DZE |
| Jul 22, 2004 | K041759 | ACE CONNECT INTERNAL CONNECTION Ace Surgical Supply Co., Inc. | DZE |
| Jul 1, 2004 | K040946 | ANKYLOS DENTAL IMPLANT SYSTEM Friadent GmbH | DZE |
| Jun 30, 2004 | K033984 | STRAUMANN DENTAL IMPLANT SYSTEM Institut Straumann AG | DZE |
| Jun 16, 2004 | K041402 | MODIFICATION TO OSSEOTITE NT CERTAIN IMPLANTS Implant Innovations, Inc. | DZE |
| Jun 9, 2004 | K040807 | MIS DENTAL IMPLANT SYSTEM Mis - Implant Technologies , Ltd. | DZE |
| May 28, 2004 | K040891 | KLS MARTIN ORTHO ANCHORAGE SYSTEM (PLATES) KLS-Martin L.P. | DZE |
| May 5, 2004 | K040983 | LORENZ SELF-DRILLING IMF SCREW Walter Lorenz Surgical, Inc. | DZE |
| Apr 27, 2004 | K033171 | NSI HEXED AND NON-HEXED IMPLANT SYSTEM AND IMMEDIATE LOADING Northern Implants, LLC | DZE |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.