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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name syringe, restorative and impression material
510(k) Number K812277
Device Name PRISMA-FIL COMPULES
Applicant
CAULK CO., DIV. DENTSPLY
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
CAULK CO., DIV. DENTSPLY
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number872.4565
Classification Product Code
EID  
Date Received08/13/1981
Decision Date 09/08/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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