FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AMERICAN DENTAL PRODUCTS ETCH-DETECT
K Number: K991099
·
Decision Jun 10, 1999
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
130
Applicant Total
23
Review Days
70
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Basic Information
- Device Name
- AMERICAN DENTAL PRODUCTS ETCH-DETECT
- K Number
- K991099
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3765
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- American Dental Products, Inc.
- Date Received
- April 1, 1999
- Decision Date
- June 10, 1999
- Product Code
- EBC
- 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 |
|---|---|---|---|
| EBC | Sealant, Pit And Fissure, And Conditioner | FDA class 2 | Dental |
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Other Clearances by American Dental Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K093014 | AMERICAN DENTAL PRODUCTS SE BONDEASY | Apr 16, 2010 | Substantially Equivalent |
| K994368 | AMERICAN DENTAL PRODUCTS CARIES-DETECTOR PLUS | Mar 14, 2000 | Substantially Equivalent |
| K973185 | AMERICAN DENTAL PRODUCTS HB-35 DESENSITIZER WITH FLUORIDE | Nov 14, 1997 | Substantially Equivalent |
| K964133 | AMERICAN DENTAL PRODUCTS HG 35 DESENSITIZER WITH FLUORIDE | Jan 9, 1997 | Substantially Equivalent |
| 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 |
| K954408 | AMERICAN DENTAL PRODUCTS LIGHT ACTIVATED COMPOSITE RESIN CORE BUILDUP BLUE PASTEE | Oct 30, 1995 | Substantially Equivalent |