Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Steri-Oss, Inc. · Predicate Candidate Screening
46 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
516 days90th percentile
46clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K982400 | STERI-OSS' IMPROV TEMPORARY DENTAL CEMENT | Steri-Oss, Inc. | 1998-09-23 | 75 | 0 |
| K980439 | REPLACE CYLINDRICAL IMPLANTS | Steri-Oss, Inc. | 1998-03-16 | 40 | 0 |
| K973433 | STERI-OSS 3.25 MM REPLACE(TITANIUM PLASMA SPRAYED) DENTAL IM | Steri-Oss, Inc. | 1997-12-05 | 86 | 0 |
| K973423 | STERI-OSS 3.25 MM REPLACE(HYDROXYAPATITE-COATED)DENTAL IMPLA | Steri-Oss, Inc. | 1997-12-05 | 86 | 0 |
| K973402 | STERI-OSS 3.25 MM REPLACE DENTAL IMPLANT SYSTEM | Steri-Oss, Inc. | 1997-11-26 | 78 | 0 |
| K972965 | STERI-OSS UNTIL IMPLANT CEMENT | Steri-Oss, Inc. | 1997-11-07 | 88 | 0 |
| K970073 | BIO-ESTHETIC INDIRECT ABUTMENT | Steri-Oss, Inc. | 1997-07-03 | 176 | 0 |
| K964739 | STERI-OSS TIODIZED SCREW | Steri-Oss, Inc. | 1997-03-31 | 125 | 0 |
| K964220 | REPLACE TITANIUM IMPLANT SYSTEM | Steri-Oss, Inc. | 1997-03-05 | 134 | 1 |
| K963945 | STERI-OSS GOLD ATTACHMENT SYSTEM | Steri-Oss, Inc. | 1997-02-11 | 132 | 0 |
| K964944 | ROUND DENTAL BUR | Steri-Oss, Inc. | 1997-02-10 | 62 | 0 |
| K963224 | STERI-OSS IMPLANTS FOR SINGLE STAGE PLACEMENT | Steri-Oss, Inc. | 1996-11-14 | 90 | 0 |
| K963897 | STERI-OSS SINUS AUGMENTATION KIT | Steri-Oss, Inc. | 1996-11-06 | 40 | 0 |
| K963121 | FIXTURE MOUNT KIT | Steri-Oss, Inc. | 1996-11-05 | 85 | 0 |
| K963401 | TPS APICAL IMPLANT | Steri-Oss, Inc. | 1996-11-05 | 68 | 0 |
| K962845 | REPLACE HA COATED IMPLANTS | Steri-Oss, Inc. | 1996-10-18 | 88 | 0 |
| K962844 | REPLACE TPS COATED IMPLANTS | Steri-Oss, Inc. | 1996-10-18 | 88 | 0 |
| K963078 | STERI-OSS TEMPORARY IMPLANT CEMENT | Steri-Oss, Inc. | 1996-09-10 | 33 | 0 |
| K962449 | OSTEO COMPACTION KIT | Steri-Oss, Inc. | 1996-09-06 | 74 | 0 |
| K960398 | STERI-OSS APICAL IMPLANT | Steri-Oss, Inc. | 1996-08-01 | 185 | 0 |
| K960886 | STERI-OSS 6 MM DIAMETER HA COATED IMPLANTS | Steri-Oss, Inc. | 1996-08-01 | 150 | 0 |
| K962120 | TOMOGRAPH ACCESSORIES | Steri-Oss, Inc. | 1996-07-25 | 55 | 0 |
| K961020 | STERI-OSS 6MM DIAMETER TPS COATED IMPLANTS | Steri-Oss, Inc. | 1996-06-05 | 85 | 0 |
| K960979 | SCREW EXTRACTION DEVICE AND THREAD CLEANING TAP | Steri-Oss, Inc. | 1996-05-20 | 70 | 0 |
| K952917 | STERI-OSS IMMEDIATE PLACEMENT IMPLANT | Steri-Oss, Inc. | 1995-10-16 | 112 | 0 |
| K953836 | ABUTMENT | Steri-Oss, Inc. | 1995-09-21 | 37 | 0 |
| K953331 | COMBINATION KIT | Steri-Oss, Inc. | 1995-09-08 | 53 | 0 |
| K953380 | LABORATORY SUPPLIES | Steri-Oss, Inc. | 1995-09-05 | 48 | 0 |
| K953103 | LAPPING TOOL KIT | Steri-Oss, Inc. | 1995-08-29 | 57 | 0 |
| K952644 | STERI-OSS SELF TAPING IMPLANT | Steri-Oss, Inc. | 1995-06-23 | 14 | 0 |
| K952120 | TORQUE LIMITER | Steri-Oss, Inc. | 1995-06-22 | 48 | 0 |
| K951065 | SURGICAL INSTRUMENT MOTOTRS AND ACCESSORIES/ATTACHMENTS | Steri-Oss, Inc. | 1995-06-08 | 92 | 0 |
| K952193 | OSTEOTOMES | Steri-Oss, Inc. | 1995-06-02 | 24 | 0 |
| K950446 | BONE CUTTING INSTRUMENT AND ACCESSORIES | Steri-Oss, Inc. | 1995-05-03 | 89 | 0 |
| K950936 | BONE CUTTING INSTRUMENT AND ACCESSORIES | Steri-Oss, Inc. | 1995-04-20 | 50 | 0 |
| K943681 | STERI-OSS SCALER FOR DENTAL IMPLANTS | Steri-Oss, Inc. | 1995-04-14 | 262 | 0 |
| K944158 | STERI-OSS TITANIUM ALLOY SCREW SERIES IMPLANT FOR SINGLE STA | Steri-Oss, Inc. | 1995-03-29 | 215 | 0 |
| K925481 | STERI-OSS TITANIUM PLASMA SPRAY SERIES IMPLANT | Steri-Oss, Inc. | 1994-09-19 | 689 | 0 |
| K925555 | STERI-OSS THREADED TPS HEX SERIES IMPLANT | Steri-Oss, Inc. | 1994-09-19 | 685 | 0 |
| K930155 | MINIBALL ABUTMENT | Steri-Oss, Inc. | 1994-02-14 | 397 | 0 |
| K923484 | STERI-OSS TITANIUM SCREW SERIES IMPLANT | Steri-Oss, Inc. | 1993-12-13 | 516 | 0 |
| K923695 | STERI-OSS SCREW STYLE CP TITANIUM IMPLANT | Steri-Oss, Inc. | 1993-12-10 | 505 | 0 |
| K924121 | STERI-OSS SCREW STYLE ITIANIUM IMPLANT | Steri-Oss, Inc. | 1993-12-10 | 483 | 0 |
| K911593 | STERI-OSS DUAL COATED CYLINDRICAL IMPLANTS | Steri-Oss, Inc. | 1993-10-07 | 912 | 0 |
| K911592 | STERI-OSS TITANIUM PLAMA SPRAY CYLINDRICAL IMPLANT | Steri-Oss, Inc. | 1993-07-22 | 835 | 0 |
| K915733 | STERI-OSS DRILLS AND TAPS | Steri-Oss, Inc. | 1992-07-17 | 210 | 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