FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ZINC CEMENT
K Number: K760978
·
Decision Nov 15, 1976
Classifications
1
FEI Numbers
144
Registration Numbers
144
Same Product Code
504
Applicant Total
11
Review Days
25
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Basic Information
- Device Name
- ZINC CEMENT
- K Number
- K760978
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3275
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Adp Intl., Inc.
- Date Received
- October 21, 1976
- Decision Date
- November 15, 1976
- 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 Adp Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K760988 | DENTAL HANDPIECES | Nov 15, 1976 | Substantially Equivalent |
| K760983 | ENDODONTIC INSTRUMENTS | Nov 15, 1976 | Substantially Equivalent |
| K760985 | HAND INSTRUMENTS | Nov 15, 1976 | Substantially Equivalent |
| K760980 | DENTAL ALLOY | Nov 15, 1976 | Substantially Equivalent |
| K760984 | ORTHODONTIC INSTRUMENTS | Nov 15, 1976 | Substantially Equivalent |
| K760982 | DENTAL VARNISH | Nov 15, 1976 | Substantially Equivalent |
| K760979 | COMPOSITE MATERIAL | Nov 15, 1976 | Substantially Equivalent |
| K760987 | DIAMOND STONES | Nov 15, 1976 | Substantially Equivalent |
| K760986 | CARBIDE DENTAL BURS | Nov 15, 1976 | Substantially Equivalent |
| K760981 | ALGINATE IMPRESSION MATERIAL | Nov 15, 1976 | Substantially Equivalent |