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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Denture, Relining, Repairing, Rebasing
510(k) Number K011820
Device Name DENTORIUM CONVERTIBLE ACRYLIC
Applicant
Nats Corp.
30 Northport Rd.
Sound Beach,  NY  11789
Applicant Contact RICHARD C LANZILLOTTO
Correspondent
Nats Corp.
30 Northport Rd.
Sound Beach,  NY  11789
Correspondent Contact RICHARD C LANZILLOTTO
Regulation Number872.3760
Classification Product Code
EBI  
Date Received06/11/2001
Decision Date 09/05/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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