FDA 510(k)
FDA class 1
Substantially Equivalent
🇧🇷 Brazil
DENTAL DIAMOND DRILLS
K Number: K923757
·
Decision Mar 16, 1993
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
20
Applicant Total
1
Review Days
231
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Basic Information
- Device Name
- DENTAL DIAMOND DRILLS
- K Number
- K923757
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4535
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Alpha Industrializacao DE Metais Ltda.
- Date Received
- July 28, 1992
- Decision Date
- March 16, 1993
- Product Code
- DZP
- 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 |
|---|---|---|---|
| DZP | Instrument, Diamond, Dental | FDA class 1 | Dental |
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