FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PRECAPSULED DENTAL AMALGAM
K Number: K822610
·
Decision Sep 14, 1982
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
3
Applicant Total
3
Review Days
15
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Basic Information
- Device Name
- PRECAPSULED DENTAL AMALGAM
- K Number
- K822610
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3110
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Syntex Dental Products, Inc.
- Date Received
- August 30, 1982
- Decision Date
- September 14, 1982
- Product Code
- DZS
- 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 |
|---|---|---|---|
| DZS | Capsule, Dental, Amalgam | FDA class 1 | Dental |
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