FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AMERICAN DENTAL PRODUCTS ORTHODONTIC ADHESIVE W/ONE STEP BONDING SYSTEM
K Number: K954333
·
Decision Oct 12, 1995
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
192
Applicant Total
23
Review Days
24
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Basic Information
- Device Name
- AMERICAN DENTAL PRODUCTS ORTHODONTIC ADHESIVE W/ONE STEP BONDING SYSTEM
- K Number
- K954333
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3750
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- American Dental Products, Inc.
- Date Received
- September 18, 1995
- Decision Date
- October 12, 1995
- Product Code
- DYH
- 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 |
|---|---|---|---|
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 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 |
| K991099 | AMERICAN DENTAL PRODUCTS ETCH-DETECT | Jun 10, 1999 | 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 |