OSSEOSPEED PROFILE EV
DENTSPLY IMPLANTS MANUFACTURING GMBH
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3013111692 | 3013111692 | Dentsply Implants Manufacturing GmbH | 1 | N | 2026-01-01 | Rodenbacher Chaussee 4 Hanau Hesse DE 63457 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 07392532290282 | Astra Tech Implant System EV Surgical Tray GS - 68017201 | +1(800)531-3481 | implants-na-cs@dentsplysirona.com |
| 07392532290299 | Astra Tech Implant System EV Surgical Tray - 68015277 | +1(800)531-3481 | implants-na-cs@dentsplysirona.com |
| D716IOSCRM30400 | SYMBIOS® - OsteoShield® Collagen Resorbable Membrane (30x40mm) | +1(800)531-3481 | implants-na-cs@dentsply.com |
| D716OSCRM15200 | SYMBIOS® - OsteoShield® Collagen Resorbable Membrane (15x20mm) | +1(800)531-3481 | implants-na-cs@dentsply.com |
| D716OSCRM20300 | SYMBIOS® - OsteoShield® Collagen Resorbable Membrane (20x30mm) | +1(800)531-3481 | implants-na-cs@dentsply.com |
| D716OSNRM12240 | SYMBIOS® - OsteoShield® PTFE Non-Resorbable Membrane (12x24mm) | +1(800)531-3481 | implants-na-cs@dentsply.com |
| D716OSNRM25300 | SYMBIOS® - OsteoShield® PTFE Non-Resorbable Membrane (25x30mm) | +1(800)531-3481 | implants-na-cs@dentsply.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 195518 | 1644641810 | K073075 | FRIALIT PLUS, XIVE S PLUS, XIVE TG PLUS, ANKYLOS PLUS, DENTAL IMPLANT SYSTEMS | DZE | 2008-03-31 |
| 195518 | 1970698285 | K060287 | DRILLTECH, ISM, IMPLANTUNIT, ZIMMER SURGICAL MOTOR SYSTEM | EBW | 2006-05-03 |
| 195518 | 1167161798 | K041509 | ANKYLOS DENTAL IMPLANT SYSTEM | DZE | 2004-08-26 |
| 195518 | 1822023247 | K040170 | FRIADENT PLUS DENTAL IMPLANT SYSTEMS | DZE | 2004-10-27 |
| 195518 | 1698328171 | K032750 | MODIFICATION TO: XIVE 3.0 DENTAL IMPLANT SYSTEM, MULTIPLE | DZE | 2003-10-02 |
| 195518 | 1621870955 | K011061 | SURGICAL CONTRA-ANGEL HANDPIECES TYPES WS-56E,WS-75E/KM,WS-92 E/3,SURGICAL STRAIGHT HANDPIECES TYPES, S-9, S-10, S-11 | EGS | 2001-06-28 |
| 195518 | 1005170314 | ||||
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| 195518 | 1980480145 | ||||
| 195518 | 1986173087 | ||||
| 195518 | 2006712508 | ||||
| 195518 | 2036169383 | ||||
| 195518 | 2061652889 |
DENTSPLY IMPLANTS MANUFACTURING GMBH
2022-07-14
2026-09-29
2026-09-29
2017-06-24
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2017-02-03
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2025-11-04
2025-11-04
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2025-11-04
2025-10-17
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