FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STERI-OSS' IMPROV TEMPORARY DENTAL CEMENT
K Number: K982400
·
Decision Sep 23, 1998
Classifications
1
FEI Numbers
144
Registration Numbers
144
Same Product Code
504
Applicant Total
46
Review Days
75
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Basic Information
- Device Name
- STERI-OSS' IMPROV TEMPORARY DENTAL CEMENT
- K Number
- K982400
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3275
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Steri-Oss, Inc.
- Date Received
- July 10, 1998
- Decision Date
- September 23, 1998
- Product Code
- EMA
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EMA | Cement, Dental | FDA class 2 | Dental |
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Other Clearances by Steri-Oss, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K980439 | REPLACE CYLINDRICAL IMPLANTS | Mar 16, 1998 | Substantially Equivalent |
| K973423 | STERI-OSS 3.25 MM REPLACE(HYDROXYAPATITE-COATED)DENTAL IMPLANT | Dec 5, 1997 | Substantially Equivalent |
| K973433 | STERI-OSS 3.25 MM REPLACE(TITANIUM PLASMA SPRAYED) DENTAL IMPLANT | Dec 5, 1997 | Substantially Equivalent |
| K973402 | STERI-OSS 3.25 MM REPLACE DENTAL IMPLANT SYSTEM | Nov 26, 1997 | Substantially Equivalent |
| K972965 | STERI-OSS UNTIL IMPLANT CEMENT | Nov 7, 1997 | Substantially Equivalent |
| K970073 | BIO-ESTHETIC INDIRECT ABUTMENT | Jul 3, 1997 | Substantially Equivalent |
| K964739 | STERI-OSS TIODIZED SCREW | Mar 31, 1997 | Substantially Equivalent |
| K964220 | REPLACE TITANIUM IMPLANT SYSTEM | Mar 5, 1997 | Substantially Equivalent |
| K963945 | STERI-OSS GOLD ATTACHMENT SYSTEM | Feb 11, 1997 | Substantially Equivalent |
| K964944 | ROUND DENTAL BUR | Feb 10, 1997 | Substantially Equivalent |