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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K951609
Device Name IMZ - DENTAL IMPLANT SURGICAL TRAY
Applicant
Imz, GmbH
9229 Cranford Dr.
Potomac,  MD  20854
Applicant Contact R. J SLOMOFF
Correspondent
Imz, GmbH
9229 Cranford Dr.
Potomac,  MD  20854
Correspondent Contact R. J SLOMOFF
Regulation Number872.3640
Classification Product Code
DZE  
Date Received04/07/1995
Decision Date 08/01/1995
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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