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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 K963520
Device Name IMZ TWIN PLUS SCREW
Applicant
Imz, GmbH
9229 Cranford Dr.
Potomac,  MD  20854
Applicant Contact ROBERT J SLOMOFF
Correspondent
Imz, GmbH
9229 Cranford Dr.
Potomac,  MD  20854
Correspondent Contact ROBERT J SLOMOFF
Regulation Number872.3640
Classification Product Code
DZE  
Date Received09/03/1996
Decision Date 08/12/1997
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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