IMPROVED DYCAL
FDA 510(k) clearance K780384 · decided 1978-03-15
Clearance details
- K-number
- K780384
- Device name
- IMPROVED DYCAL
- Applicant
- L.D. Caulk Co.
- Decision
- Substantially Equivalent
- Date received
- 1978-03-09
- Decision date
- 1978-03-15
- Days to decision
- 6 days
- Clearance type
- Traditional
- Product code
- EJK
- Device class
- 2
- Regulation number
- 872.3250
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OMNIPLASTIC BONE CEMENT (N17113) | L.D. Caulk Co. | 1981-09-16 |