Not currently registered with FDA under this name
Steri-Oss, Inc.
Yorba Linda, CA, United States. Named as applicant on 46 dental 510(k) clearances between 1992 and 1998. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 461992–1998
- Markets registered in
- 23 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1990–2026
Registered in 2 markets
Where regulators' registries name Steri-Oss, Inc. as the manufacturer or the registration holder of a device.
RegisteredHome: United StatesOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Steri-Oss, Inc. | 46 clearances | 1992–1998 | Below |
| South Korea | MFDS | Manufacturer | Steri-oss Inc.Steri -oss Inc | 3 | 1998–1998 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
510(k) clearances
Clearances on which FDA names Steri-Oss, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 23 Sep 1998 | K982400 | STERI-OSS' IMPROV TEMPORARY DENTAL CEMENT | EMA Dental Cement |
| 16 Mar 1998 | K980439 | REPLACE CYLINDRICAL IMPLANTS | DZE Root-Form Endosseous Implant |
| 5 Dec 1997 | K973433 | STERI-OSS 3.25 MM REPLACE(TITANIUM PLASMA SPRAYED) DENTAL IMPLANT | DZE Root-Form Endosseous Implant |
| 5 Dec 1997 | K973423 | STERI-OSS 3.25 MM REPLACE(HYDROXYAPATITE-COATED)DENTAL IMPLANT | DZE Root-Form Endosseous Implant |
| 26 Nov 1997 | K973402 | STERI-OSS 3.25 MM REPLACE DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 7 Nov 1997 | K972965 | STERI-OSS UNTIL IMPLANT CEMENT | EMA Dental Cement |
| 3 Jul 1997 | K970073 | BIO-ESTHETIC INDIRECT ABUTMENT | NHA Endosseous Dental Implant Abutment |
| 31 Mar 1997 | K964739 | STERI-OSS TIODIZED SCREW | DZE Root-Form Endosseous Implant |
| 5 Mar 1997 | K964220 | REPLACE TITANIUM IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 11 Feb 1997 | K963945 | STERI-OSS GOLD ATTACHMENT SYSTEM | DZE Root-Form Endosseous Implant |
| 10 Feb 1997 | K964944 | ROUND DENTAL BUR | DZE Root-Form Endosseous Implant |
| 14 Nov 1996 | K963224 | STERI-OSS IMPLANTS FOR SINGLE STAGE PLACEMENT | DZE Root-Form Endosseous Implant |
| 6 Nov 1996 | K963897 | STERI-OSS SINUS AUGMENTATION KIT | EMM Surgical Osteotome Chisel |
| 5 Nov 1996 | K963401 | TPS APICAL IMPLANT | DZE Root-Form Endosseous Implant |
| 5 Nov 1996 | K963121 | FIXTURE MOUNT KIT | DZE Root-Form Endosseous Implant |
| 18 Oct 1996 | K962845 | REPLACE HA COATED IMPLANTS | DZE Root-Form Endosseous Implant |
| 18 Oct 1996 | K962844 | REPLACE TPS COATED IMPLANTS | DZE Root-Form Endosseous Implant |
| 10 Sep 1996 | K963078 | STERI-OSS TEMPORARY IMPLANT CEMENT | EMA Dental Cement |
| 6 Sep 1996 | K962449 | OSTEO COMPACTION KIT | DZE Root-Form Endosseous Implant |
| 1 Aug 1996 | K960886 | STERI-OSS 6 MM DIAMETER HA COATED IMPLANTS | DZE Root-Form Endosseous Implant |
| 1 Aug 1996 | K960398 | STERI-OSS APICAL IMPLANT | DZE Root-Form Endosseous Implant |
| 25 Jul 1996 | K962120 | TOMOGRAPH ACCESSORIES | EHD Extraoral with Timer X-Ray Unit |
| 5 Jun 1996 | K961020 | STERI-OSS 6MM DIAMETER TPS COATED IMPLANTS | DZE Root-Form Endosseous Implant |
| 20 May 1996 | K960979 | SCREW EXTRACTION DEVICE AND THREAD CLEANING TAP | DZE Root-Form Endosseous Implant |
| 16 Oct 1995 | K952917 | STERI-OSS IMMEDIATE PLACEMENT IMPLANT | DZE Root-Form Endosseous Implant |
| 21 Sep 1995 | K953836 | ABUTMENT | DZE Root-Form Endosseous Implant |
| 8 Sep 1995 | K953331 | COMBINATION KIT | DZE Root-Form Endosseous Implant |
| 5 Sep 1995 | K953380 | LABORATORY SUPPLIES | DZE Root-Form Endosseous Implant |
| 29 Aug 1995 | K953103 | LAPPING TOOL KIT | DZE Root-Form Endosseous Implant |
| 23 Jun 1995 | K952644 | STERI-OSS SELF TAPING IMPLANT | DZE Root-Form Endosseous Implant |
| 22 Jun 1995 | K952120 | TORQUE LIMITER | DZE Root-Form Endosseous Implant |
| 8 Jun 1995 | K951065 | SURGICAL INSTRUMENT MOTOTRS AND ACCESSORIES/ATTACHMENTS | DZE Root-Form Endosseous Implant |
| 2 Jun 1995 | K952193 | OSTEOTOMES | DZE Root-Form Endosseous Implant |
| 3 May 1995 | K950446 | BONE CUTTING INSTRUMENT AND ACCESSORIES | DZE Root-Form Endosseous Implant |
| 20 Apr 1995 | K950936 | BONE CUTTING INSTRUMENT AND ACCESSORIES | DZE Root-Form Endosseous Implant |
| 14 Apr 1995 | K943681 | STERI-OSS SCALER FOR DENTAL IMPLANTS | DZE Root-Form Endosseous Implant |
| 29 Mar 1995 | K944158 | STERI-OSS TITANIUM ALLOY SCREW SERIES IMPLANT FOR SINGLE STAGE SURGICAL PLACEMENT | DZE Root-Form Endosseous Implant |
| 19 Sep 1994 | K925555 | STERI-OSS THREADED TPS HEX SERIES IMPLANT | DZE Root-Form Endosseous Implant |
| 19 Sep 1994 | K925481 | STERI-OSS TITANIUM PLASMA SPRAY SERIES IMPLANT | DZE Root-Form Endosseous Implant |
| 14 Feb 1994 | K930155 | MINIBALL ABUTMENT | DZE Root-Form Endosseous Implant |
| 13 Dec 1993 | K923484 | STERI-OSS TITANIUM SCREW SERIES IMPLANT | DZE Root-Form Endosseous Implant |
| 10 Dec 1993 | K924121 | STERI-OSS SCREW STYLE ITIANIUM IMPLANT | DZE Root-Form Endosseous Implant |
| 10 Dec 1993 | K923695 | STERI-OSS SCREW STYLE CP TITANIUM IMPLANT | DZE Root-Form Endosseous Implant |
| 7 Oct 1993 | K911593 | STERI-OSS DUAL COATED CYLINDRICAL IMPLANTS | DZE Root-Form Endosseous Implant |
| 22 Jul 1993 | K911592 | STERI-OSS TITANIUM PLAMA SPRAY CYLINDRICAL IMPLANT | DZE Root-Form Endosseous Implant |
| 17 Jul 1992 | K915733 | STERI-OSS DRILLS AND TAPS | DZE Root-Form Endosseous Implant |
Some of these clearances are listed with FDA today by another company: Nobel Biocare Services AG (5), Scientific Pharmaceuticals (1).
Sources
FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.