BISICO SL(PUTTY) BISICO S2(REGULAR) S3 HEAVY ETC.
FDA 510(k) clearance K844446 · decided 1985-10-29
Clearance details
- K-number
- K844446
- Device name
- BISICO SL(PUTTY) BISICO S2(REGULAR) S3 HEAVY ETC.
- Applicant
- Pulpdent Corp. of America
- Decision
- Substantially Equivalent
- Date received
- 1984-11-16
- Decision date
- 1985-10-29
- Days to decision
- 347 days
- Clearance type
- Traditional
- Product code
- ELW
- Device class
- 2
- Regulation number
- 872.3660
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Brookline, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.