Implant Innovations International, Inc.
West Palm Beach, FL, US
Implant Innovations International, Inc. appears in FDA device records in West Palm Beach, FL. FDA records list 18 510(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
- 18
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 18 510(k) clearances for Implant Innovations International, Inc. between 1987 and 1995. The busiest year on record is 1987, with 6. The most recent is 1995, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1987 | 6 |
| 1988 | 2 |
| 1989 | 5 |
| 1991 | 3 |
| 1994 | 1 |
| 1995 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K935544 | 3I STANDARD THREADED/SELF-TAPPING THREADED IMPLANTS MODIFICATION | DZE | Substantially Equivalent | |
| K932123 | IMPLANT INNOVATION PRE-ANGLED ABUTMENT SYSTEM | DZE | Substantially Equivalent | |
| K911655 | IMPLARETTE | EKJ | Substantially Equivalent | |
| K905303 | ABUTMENT GLO | EJR | Substantially Equivalent | |
| K911701 | G-FLOSS & G-FLOSS II | JES | Substantially Equivalent | |
| K891613 | OVERDENTURE ATTACHMENT | DZE | Substantially Equivalent | |
| K891612 | DRILLING MACHINE W/HANDPIECES & INTERNAL IRRIGA. | EFD | Substantially Equivalent | |
| K891617 | INSERTION TOOLS | DZE | Substantially Equivalent | |
| K891618 | TITANIUM FORCEPS | DZE | Substantially Equivalent | |
| K891615 | SURGICAL DRILLS | DZE | Substantially Equivalent | |
| K874590 | INNOVATIVE IMPLANTS AND COVER SCREWS | DZE | Substantially Equivalent | |
| K874400 | NON-ROTATING GOLD CYLINDER AND SCREW | DZE | Substantially Equivalent | |
| K874401 | TITANIUM SUCTION TIP | EHZ | Substantially Equivalent | |
| K871955 | TEMPORARY SCREW | DZE | Substantially Equivalent | |
| K871954 | ABUTMENT HEAD POST | DZE | Substantially Equivalent | |
| K871953 | TEMPORARY BRIDGE HEAD | DZE | Substantially Equivalent | |
| K871863 | ADBUTMENT CYLINDER AND SCREW | DZE | Substantially Equivalent | |
| K871862 | POST. SCREW & HEX DRIVER/ADBUT & ADBUT HEAD DRIVER | 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