FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PERIODONTAL INSTRUMENT #21 GOLDMAN-FOX
K Number: K781035
·
Decision Jun 30, 1978
Classifications
1
FEI Numbers
213
Registration Numbers
213
Same Product Code
4
Applicant Total
41
Review Days
11
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Basic Information
- Device Name
- PERIODONTAL INSTRUMENT #21 GOLDMAN-FOX
- K Number
- K781035
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Premier Dental Products Co.
- Date Received
- June 19, 1978
- Decision Date
- June 30, 1978
- Product Code
- EMN
- 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 |
|---|---|---|---|
| EMN | Scaler, Periodontic | FDA class 1 | Dental |
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| K051866 | PREMIER TEMPORARY CEMENT | Sep 6, 2005 | Substantially Equivalent |
| K042215 | RADIOPAQUE, GLASS IONOMER ENDODONTIC CEMENT | Sep 21, 2004 | Substantially Equivalent |