FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AMALGAMATOR
K Number: K880993
·
Decision May 11, 1988
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
14
Applicant Total
1
Review Days
64
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Basic Information
- Device Name
- AMALGAMATOR
- K Number
- K880993
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3100
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Acecodent, Inc.
- Date Received
- March 8, 1988
- Decision Date
- May 11, 1988
- Product Code
- EFD
- 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 |
|---|---|---|---|
| EFD | Amalgamator, Dental, Ac-Powered | FDA class 1 | Dental |
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