Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
O Co., Inc. — Predicate Candidate Screening
17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
108 daysmedian FDA review time
531 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K033392 | IMMEDIATE STABILIZING IMPLANT (ISI) | O Co., Inc. | 2003-12-10 | 48 | 0 |
| K023336 | OCO DENTAL IMPLANT (5.0MM DIAMETER) | O Co., Inc. | 2002-10-09 | 2 | 0 |
| K021460 | OCO DENTAL IMPLANT | O Co., Inc. | 2002-05-22 | 15 | 0 |
| K011524 | IMMEDIATE STABILIZING DEVICE (ISD) | O Co., Inc. | 2002-04-10 | 328 | 0 |
| K010142 | OCO DENTAL IMPLANT | O Co., Inc. | 2001-02-01 | 15 | 0 |
| K973926 | O BUTMENT HS IMPLANT | O Co., Inc. | 1998-01-05 | 82 | 0 |
| K961665 | O BUTMENT ET IMPLANT | O Co., Inc. | 1996-11-15 | 199 | 0 |
| K950066 | DENTAL IMPLANT ENDOSSEOUS | O Co., Inc. | 1995-09-15 | 249 | 0 |
| K946113 | IMPLANT BODY RETRIEVER/REMOVER | O Co., Inc. | 1995-03-01 | 76 | 0 |
| K946129 | IMPLANT BODY DEPTH GAUGE/TRYIN | O Co., Inc. | 1995-03-01 | 75 | 0 |
| K945300 | ACCESSORY ITEM TO ENDOSSEOUS DENTAL IMPLANT | O Co., Inc. | 1995-02-16 | 108 | 0 |
| K944904 | PARRALLEL PIN | O Co., Inc. | 1995-02-16 | 134 | 0 |
| K923889 | O BUTMENT ES IMPLANT | O Co., Inc. | 1994-08-29 | 755 | 0 |
| K921933 | O BUTMENT HB | O Co., Inc. | 1992-07-08 | 75 | 0 |
| K903999 | OBUTMENT HB | O Co., Inc. | 1992-02-11 | 531 | 0 |
| K903211 | O BUTMENT | O Co., Inc. | 1991-03-29 | 252 | 0 |
| K884296 | O BUTMENT | O Co., Inc. | 1989-08-01 | 293 | 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