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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 K895333
Device Name OSSEODENT PROSTHETIC KIT
Applicant
Celtrix Laboratories
2500 Faber Pl.
Palo Alto,  CA  94303
Applicant Contact CINDY DOMECUS
Correspondent
Celtrix Laboratories
2500 Faber Pl.
Palo Alto,  CA  94303
Correspondent Contact CINDY DOMECUS
Regulation Number872.3640
Classification Product Code
DZE  
Date Received08/31/1989
Decision Date 11/29/1989
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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