CALCIUM HYDROXIDE PASTE
FDA 510(k) clearance K943372 · decided 1994-09-19
Clearance details
- K-number
- K943372
- Device name
- CALCIUM HYDROXIDE PASTE
- Applicant
- Ultradent Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-07-13
- Decision date
- 1994-09-19
- Days to decision
- 68 days
- Clearance type
- Traditional
- Product code
- EJK
- Device class
- 2
- Regulation number
- 872.3250
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- South Jordan, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.