BOSWORTH COPALIONER
FDA 510(k) clearance K933505 · decided 1994-01-07
Clearance details
- K-number
- K933505
- Device name
- BOSWORTH COPALIONER
- Applicant
- Harry J. Bosworth Co.
- Decision
- Substantially Equivalent
- Date received
- 1993-07-15
- Decision date
- 1994-01-07
- Days to decision
- 176 days
- Clearance type
- Traditional
- Product code
- LBH
- Device class
- 2
- Regulation number
- 872.3260
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Skokie, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Keystone Bosworth Copaliner Cavity Varnish .5oz (14 ml)- Intended to provide a marginal se recall (Z-2579-2023) | Keystone Industries | 2023-09-12 |