FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AMERICAN DENTAL PRODUCTS ALGINATE FLAVORING
K Number: K954223
·
Decision Sep 29, 1995
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
401
Applicant Total
23
Review Days
18
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Basic Information
- Device Name
- AMERICAN DENTAL PRODUCTS ALGINATE FLAVORING
- K Number
- K954223
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- American Dental Products, Inc.
- Date Received
- September 11, 1995
- Decision Date
- September 29, 1995
- Product Code
- ELW
- 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 |
|---|---|---|---|
| ELW | Material, Impression | FDA class 2 | Dental |
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|---|---|---|---|
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| K954637 | AMERICAN DENTAL PRODUCTS TISSUE CONDITIONER & TEMPORARY RELINER | Dec 28, 1995 | Substantially Equivalent |
| K954876 | AMERICAN DENTAL PRODUCTS ROOT CANAL SEALER, WACH'S FORMULA | Nov 15, 1995 | Substantially Equivalent |
| K954406 | AMERICAN DENTAL PRODUCTS COMPOSITE RESIN CORE PASTE WITH FLUORIDE | Oct 30, 1995 | Substantially Equivalent |
| K954701 | AMERICAN DENTAL PRODUCTS PIT & FISSUE SEALANT LIGHT CURING | Oct 30, 1995 | Substantially Equivalent |
| K954407 | AMERICAN DENTAL PRODUCTS WHITE COMPOSITE RESIN CORE PASTE WITH FLUORIDE | Oct 30, 1995 | Substantially Equivalent |