PRECAPSULED DENTAL AMALGAM
FDA 510(k) clearance K822610 · decided 1982-09-14
Clearance details
- K-number
- K822610
- Device name
- PRECAPSULED DENTAL AMALGAM
- Applicant
- Syntex Dental Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-08-30
- Decision date
- 1982-09-14
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- DZS
- Device class
- 1
- Regulation number
- 872.3110
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Mchenry, IL, 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 |
|---|---|---|
| DISPERSALLOY-DISPERSED PHASE ALLOY SELF- (K802967) | Johnson & Johnson Professionals, Inc. | 1980-12-30 |
| 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.