Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Implant Innovations International, Inc. · Predicate Candidate Screening
18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
72 daysmedian FDA review time
389 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K935544 | 3I STANDARD THREADED/SELF-TAPPING THREADED IMPLANTS MODIFICA | Implant Innovations International, Inc. | 1995-03-13 | 486 | 0 |
| K932123 | IMPLANT INNOVATION PRE-ANGLED ABUTMENT SYSTEM | Implant Innovations International, Inc. | 1994-05-27 | 389 | 0 |
| K911655 | IMPLARETTE | Implant Innovations International, Inc. | 1991-10-21 | 192 | 0 |
| K905303 | ABUTMENT GLO | Implant Innovations International, Inc. | 1991-06-10 | 194 | 0 |
| K911701 | G-FLOSS & G-FLOSS II | Implant Innovations International, Inc. | 1991-05-15 | 29 | 0 |
| K891613 | OVERDENTURE ATTACHMENT | Implant Innovations International, Inc. | 1989-10-10 | 204 | 6 |
| K891612 | DRILLING MACHINE W/HANDPIECES & INTERNAL IRRIGA. | Implant Innovations International, Inc. | 1989-06-12 | 84 | 0 |
| K891617 | INSERTION TOOLS | Implant Innovations International, Inc. | 1989-05-01 | 42 | 0 |
| K891615 | SURGICAL DRILLS | Implant Innovations International, Inc. | 1989-04-17 | 28 | 0 |
| K891618 | TITANIUM FORCEPS | Implant Innovations International, Inc. | 1989-04-17 | 28 | 0 |
| K874590 | INNOVATIVE IMPLANTS AND COVER SCREWS | Implant Innovations International, Inc. | 1988-05-11 | 184 | 0 |
| K874400 | NON-ROTATING GOLD CYLINDER AND SCREW | Implant Innovations International, Inc. | 1988-03-02 | 126 | 1 |
| K874401 | TITANIUM SUCTION TIP | Implant Innovations International, Inc. | 1987-11-12 | 15 | 0 |
| K871953 | TEMPORARY BRIDGE HEAD | Implant Innovations International, Inc. | 1987-07-31 | 72 | 0 |
| K871954 | ABUTMENT HEAD POST | Implant Innovations International, Inc. | 1987-07-31 | 72 | 0 |
| K871955 | TEMPORARY SCREW | Implant Innovations International, Inc. | 1987-07-31 | 72 | 0 |
| K871862 | POST. SCREW & HEX DRIVER/ADBUT & ADBUT HEAD DRIVER | Implant Innovations International, Inc. | 1987-07-10 | 58 | 0 |
| K871863 | ADBUTMENT CYLINDER AND SCREW | Implant Innovations International, Inc. | 1987-07-10 | 58 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda