FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PERMITE DENTAL AMALGAM ALLOY
K Number: K801639
·
Decision Aug 27, 1980
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
73
Applicant Total
21
Review Days
41
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Basic Information
- Device Name
- PERMITE DENTAL AMALGAM ALLOY
- K Number
- K801639
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3070
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Southern Dental Industries, Inc.
- Date Received
- July 17, 1980
- Decision Date
- August 27, 1980
- Product Code
- EJJ
- 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 |
|---|---|---|---|
| EJJ | Alloy, Amalgam | FDA class 2 | Dental |
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| K032152 | BENCO ADMIX | Aug 6, 2003 | Substantially Equivalent |
| K031658 | BENCO SPHERICAL | Jul 29, 2003 | Substantially Equivalent |
| K030568 | RADII | Apr 24, 2003 | Substantially Equivalent |