SEAL BLOCK PRO (NOT FINALIZED), SEAL BLOCK OTC (NOT FINALIZED)
FDA 510(k) clearance K123653 · decided 2013-06-03
Clearance details
- K-number
- K123653
- Device name
- SEAL BLOCK PRO (NOT FINALIZED), SEAL BLOCK OTC (NOT FINALIZED)
- Applicant
- Bisco, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-11-27
- Decision date
- 2013-06-03
- Days to decision
- 188 days
- Clearance type
- Traditional
- Product code
- LBH
- Device class
- 2
- Regulation number
- 872.3260
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Schaumburg, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.