JOHNSON & JOHNSON OPAQUE COLOR MODIFI
FDA 510(k) clearance K830491 · decided 1983-03-17
Clearance details
- K-number
- K830491
- Device name
- JOHNSON & JOHNSON OPAQUE COLOR MODIFI
- Applicant
- Johnson & Johnson Professionals, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-02-15
- Decision date
- 1983-03-17
- Days to decision
- 30 days
- Clearance type
- Traditional
- Product code
- EBE
- Device class
- 2
- Regulation number
- 872.3300
- 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 |
|---|---|---|
| CS-11 (K832500) | Chema-Scutum, Inc. | 1983-10-27 |
| CONCEPT II (K790339) | Richardson Merrel, Inc. | 1979-07-17 |
Recalls involving this device
No recalls on record reference this clearance.