FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
3D DENTAL DIAMOND ROTARY INSTRUMENTS
K Number: K893844
·
Decision Aug 11, 1989
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
20
Applicant Total
3
Review Days
78
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Basic Information
- Device Name
- 3D DENTAL DIAMOND ROTARY INSTRUMENTS
- K Number
- K893844
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4535
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Lustgarten Multi-Tech International, Inc.
- Date Received
- May 25, 1989
- Decision Date
- August 11, 1989
- 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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