DISPERSALLOY-DISPERSED PHASE ALLOY SELF-
FDA 510(k) clearance K802967 · decided 1980-12-30
Clearance details
- K-number
- K802967
- Device name
- DISPERSALLOY-DISPERSED PHASE ALLOY SELF-
- Applicant
- Johnson & Johnson Professionals, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-11-21
- Decision date
- 1980-12-30
- Days to decision
- 39 days
- Clearance type
- Traditional
- Product code
- DZS
- Device class
- 1
- Regulation number
- 872.3110
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Raynham, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PRECAPSULED DENTAL AMALGAM (K822610) | Syntex Dental Products, Inc. | 1982-09-14 |
| MERCURY DISP. CAPSULE (K781243) | Lee Pharmaceuticals | 1978-09-20 |
| LEE-ALLOY DISPOSABLE CAPSULES (K780966) | Lee Pharmaceuticals | 1978-08-21 |
Recalls involving this device
No recalls on record reference this clearance.