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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 K921805
Device Name STRYKER PRECISION DENTAL IMPLANT SYSTEM
Applicant
Stryker Instruments
420 Alcott St.
Kalamazoo,  MI  49001
Applicant Contact CHAD A COBERLY
Correspondent
Stryker Instruments
420 Alcott St.
Kalamazoo,  MI  49001
Correspondent Contact CHAD A COBERLY
Regulation Number872.3640
Classification Product Code
DZE  
Date Received04/15/1992
Decision Date 03/10/1994
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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