Steri-Oss, Inc.
Anaheim, CA, US
Steri-Oss, Inc. appears in FDA device records in Anaheim, CA. FDA records list 46 510(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
- 46
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 46 510(k) clearances for Steri-Oss, Inc. between 1992 and 1998. The busiest year on record is 1995, with 13. The most recent is 1998, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1992 | 1 |
| 1993 | 5 |
| 1994 | 3 |
| 1995 | 13 |
| 1996 | 13 |
| 1997 | 9 |
| 1998 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K982400 | STERI-OSS' IMPROV TEMPORARY DENTAL CEMENT | EMA | Substantially Equivalent | |
| K980439 | REPLACE CYLINDRICAL IMPLANTS | DZE | Substantially Equivalent | |
| K973433 | STERI-OSS 3.25 MM REPLACE(TITANIUM PLASMA SPRAYED) DENTAL IMPLANT | DZE | Substantially Equivalent | |
| K973423 | STERI-OSS 3.25 MM REPLACE(HYDROXYAPATITE-COATED)DENTAL IMPLANT | DZE | Substantially Equivalent | |
| K973402 | STERI-OSS 3.25 MM REPLACE DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | |
| K972965 | STERI-OSS UNTIL IMPLANT CEMENT | EMA | Substantially Equivalent | |
| K970073 | BIO-ESTHETIC INDIRECT ABUTMENT | NHA | Substantially Equivalent | |
| K964739 | STERI-OSS TIODIZED SCREW | DZE | Substantially Equivalent | |
| K964220 | REPLACE TITANIUM IMPLANT SYSTEM | DZE | Substantially Equivalent | |
| K963945 | STERI-OSS GOLD ATTACHMENT SYSTEM | DZE | Substantially Equivalent | |
| K964944 | ROUND DENTAL BUR | DZE | Substantially Equivalent | |
| K963224 | STERI-OSS IMPLANTS FOR SINGLE STAGE PLACEMENT | DZE | Substantially Equivalent | |
| K963897 | STERI-OSS SINUS AUGMENTATION KIT | EMM | Substantially Equivalent | |
| K963401 | TPS APICAL IMPLANT | DZE | Substantially Equivalent | |
| K963121 | FIXTURE MOUNT KIT | DZE | Substantially Equivalent | |
| K962845 | REPLACE HA COATED IMPLANTS | DZE | Substantially Equivalent | |
| K962844 | REPLACE TPS COATED IMPLANTS | DZE | Substantially Equivalent | |
| K963078 | STERI-OSS TEMPORARY IMPLANT CEMENT | EMA | Substantially Equivalent | |
| K962449 | OSTEO COMPACTION KIT | DZE | Substantially Equivalent | |
| K960886 | STERI-OSS 6 MM DIAMETER HA COATED IMPLANTS | DZE | Substantially Equivalent | |
| K960398 | STERI-OSS APICAL IMPLANT | DZE | Substantially Equivalent | |
| K962120 | TOMOGRAPH ACCESSORIES | EHD | Substantially Equivalent | |
| K961020 | STERI-OSS 6MM DIAMETER TPS COATED IMPLANTS | DZE | Substantially Equivalent | |
| K960979 | SCREW EXTRACTION DEVICE AND THREAD CLEANING TAP | DZE | Substantially Equivalent | |
| K952917 | STERI-OSS IMMEDIATE PLACEMENT IMPLANT | DZE | Substantially Equivalent | |
| K953836 | ABUTMENT | DZE | Substantially Equivalent | |
| K953331 | COMBINATION KIT | DZE | Substantially Equivalent | |
| K953380 | LABORATORY SUPPLIES | DZE | Substantially Equivalent | |
| K953103 | LAPPING TOOL KIT | DZE | Substantially Equivalent | |
| K952644 | STERI-OSS SELF TAPING IMPLANT | DZE | Substantially Equivalent | |
| K952120 | TORQUE LIMITER | DZE | Substantially Equivalent | |
| K951065 | SURGICAL INSTRUMENT MOTOTRS AND ACCESSORIES/ATTACHMENTS | DZE | Substantially Equivalent | |
| K952193 | OSTEOTOMES | DZE | Substantially Equivalent | |
| K950446 | BONE CUTTING INSTRUMENT AND ACCESSORIES | DZE | Substantially Equivalent | |
| K950936 | BONE CUTTING INSTRUMENT AND ACCESSORIES | DZE | Substantially Equivalent | |
| K943681 | STERI-OSS SCALER FOR DENTAL IMPLANTS | DZE | Substantially Equivalent | |
| K944158 | STERI-OSS TITANIUM ALLOY SCREW SERIES IMPLANT FOR SINGLE STAGE SURGICAL PLACEMENT | DZE | Substantially Equivalent | |
| K925555 | STERI-OSS THREADED TPS HEX SERIES IMPLANT | DZE | Substantially Equivalent | |
| K925481 | STERI-OSS TITANIUM PLASMA SPRAY SERIES IMPLANT | DZE | Substantially Equivalent | |
| K930155 | MINIBALL ABUTMENT | DZE | Substantially Equivalent | |
| K923484 | STERI-OSS TITANIUM SCREW SERIES IMPLANT | DZE | Substantially Equivalent | |
| K924121 | STERI-OSS SCREW STYLE ITIANIUM IMPLANT | DZE | Substantially Equivalent | |
| K923695 | STERI-OSS SCREW STYLE CP TITANIUM IMPLANT | DZE | Substantially Equivalent | |
| K911593 | STERI-OSS DUAL COATED CYLINDRICAL IMPLANTS | DZE | Substantially Equivalent | |
| K911592 | STERI-OSS TITANIUM PLAMA SPRAY CYLINDRICAL IMPLANT | DZE | Substantially Equivalent | |
| K915733 | STERI-OSS DRILLS AND TAPS | 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