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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Post, Root Canal
510(k) Number K851038
Device Name ARCEE DENTAL POST
Applicant
Arcee Dental Products Co.
1021 E. 7th. St.
Brooklyn,  NY  11230
Applicant Contact FRAY S LEVINE
Correspondent
Arcee Dental Products Co.
1021 E. 7th. St.
Brooklyn,  NY  11230
Correspondent Contact FRAY S LEVINE
Regulation Number872.3810
Classification Product Code
ELR  
Date Received03/14/1985
Decision Date 04/29/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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