Implant Center of the Palm Beaches
N. Palm Beach, FL, US
Implant Center of the Palm Beaches appears in FDA device records in N. Palm Beach, FL. FDA records list 32 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 32
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 32 510(k) clearances for Implant Center of the Palm Beaches between 1994 and 1998. The busiest year on record is 1995, with 26. The most recent is 1998, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 1 |
| 1995 | 26 |
| 1996 | 4 |
| 1998 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K974280 | ABUTMENT - COMPLETE | DZE | Substantially Equivalent | |
| K960111 | KIS MT4 | DZE | Substantially Equivalent | |
| K960110 | KIS MT3 | DZE | Substantially Equivalent | |
| K960112 | KIS MT5 | DZE | Substantially Equivalent | |
| K955048 | KIS MED THREAD IMPLANT & PROSTHESIS SYSTEM | DZE | Substantially Equivalent | |
| K953558 | KIS II LG HEX SCREW & CYLINDER IMPLANTS | DZE | Substantially Equivalent | |
| K953234 | SCREW IMPLANTS, GRADE 3; UNCOATED, HA, TP-B3 | DZE | Substantially Equivalent | |
| K953001 | TP-4K SCREW IMPLANT 3.3, 3.75, 4.0 | DZE | Substantially Equivalent | |
| K953000 | WIDE SYSTEM SCREW B5 UNCOATED 5MM, 6MM | DZE | Substantially Equivalent | |
| K952999 | UNCOATED SCREW IMPLANT 3.75, 4.0-B5 | DZE | Substantially Equivalent | |
| K952998 | TP SCREW IMPLANT 3.75, 4.0-B5 | DZE | Substantially Equivalent | |
| K952997 | PRE ANGULATED PROSTH: 15 DEG ANGLED, 25,& 25 CONE ANGLED | DZE | Substantially Equivalent | |
| K952996 | HA/TP COATED CYLINDER IMPLANT 3.3,4.0 | DZE | Substantially Equivalent | |
| K952994 | TP-4 WIDE CYLINDER IMPLANTS | DZE | Substantially Equivalent | |
| K952992 | PROSTHETICS 4MM | DZE | Substantially Equivalent | |
| K952991 | WIDE SCREW HA-5B, CYL-HA-5 | DZE | Substantially Equivalent | |
| K952985 | WIDE SCREWS TP-5B. PROS G5, TOOLS G5 OR 17-4 SS | DZE | Substantially Equivalent | |
| K954539 | LG HEX PROSTHETICS | DZE | Substantially Equivalent | |
| K953281 | HA, TP CYLINDER OVAL | DZE | Substantially Equivalent | |
| K953280 | HA, TP CYLINDER, UNIHOLE | DZE | Substantially Equivalent | |
| K953237 | PROSTHETICS & INSTRUMENTATION A. PROSTHETIC ABUTMENTS 4, 5, 6 DIAMETER, GRADE 3, B. IRRIGATION DRILLS, TOOLING & PREANG' | DZE | Substantially Equivalent | |
| K953236 | CYLINDER IMPLANTS HA, TP, GRADE 3 | DZE | Substantially Equivalent | |
| K953235 | SCREW IMPLANTS, GRADE 3; UNCOATED, HA, TP-K3 | DZE | Substantially Equivalent | |
| K953139 | KIS-- FOUR HOLE CYLINDER | DZE | Substantially Equivalent | |
| K952989 | WIDE STR-TP-4K, PROS STR, CLY-STR-TP 4 | DZE | Substantially Equivalent | |
| K952988 | WIDE SCREWS TP-4K, PROS-G4, TOOLS G4 OR 17-4 SS | DZE | Substantially Equivalent | |
| K951606 | KIS-II IMPLANT FIXTURES | DZE | Substantially Equivalent | |
| K950893 | KIS-V PRE-ANGULATED AND WIDE BODY ABUTMENTS | DZE | Substantially Equivalent | |
| K944725 | KIS-II STR FIXTURES | DZE | Substantially Equivalent | |
| K943984 | KIS-II NON-ANGULATED ABUTMENTS | DZE | Substantially Equivalent | |
| K943971 | KIS-II IMPLANT FIXTURES | DZE | Substantially Equivalent | |
| K944356 | KIS-II IMPLANT SYSTEM/DRILLS | DZE | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain