FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DISPERSALLOY-DISPERSED PHASE ALLOY SELF-
K Number: K802967
·
Decision Dec 30, 1980
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
3
Applicant Total
206
Review Days
39
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Basic Information
- Device Name
- DISPERSALLOY-DISPERSED PHASE ALLOY SELF-
- K Number
- K802967
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3110
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Johnson & Johnson Professionals, Inc.
- Date Received
- November 21, 1980
- Decision Date
- December 30, 1980
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DZS), ordered by most recent decision date.
PRECAPSULED DENTAL AMALGAM
FDA 510(k)
FDA Class 1
·Dental
MERCURY DISP. CAPSULE
FDA 510(k)
FDA Class 1
·Dental
LEE-ALLOY DISPOSABLE CAPSULES
FDA 510(k)
FDA Class 1
·Dental
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