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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name solution, cement dissolving
510(k) Number K771974
Device Name SOLVENEX I-0
Applicant
DEN-MAT CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
DEN-MAT CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number872.3750
Classification Product Code
KZP  
Date Received10/17/1977
Decision Date 01/12/1978
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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