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FDA 510(k), K033938, CLEARFIL PROTECT BOND
FDA 510(k), K033938, CLEARFIL PROTECT BOND
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510(K) Number: K033938
Device Name: CLEARFIL PROTECT BOND
Manufacturer: KEITH A BARRITT
Device Classification Name: Agent, Tooth Bonding, Resin
Regulation Number: KLE
Classification Product Code: KXA
Date Received: 12/19/2003
Decision Date: 01/29/2004
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
Device Name: CLEARFIL PROTECT BOND
Manufacturer: KEITH A BARRITT
Device Classification Name: Agent, Tooth Bonding, Resin
Regulation Number: KLE
Classification Product Code: KXA
Date Received: 12/19/2003
Decision Date: 01/29/2004
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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