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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 K926311
Device Name PHOENIX 4.0 MM ANGLED DENTAL ATTACHMENTS
Applicant
Vancouver Implant Center
3555 Sykes Rd.
North Vancouver, Bc Canada
V7k 2x4,  CA
Applicant Contact VIC MARQUES
Correspondent
Vancouver Implant Center
3555 Sykes Rd.
North Vancouver, Bc Canada
V7k 2x4,  CA
Correspondent Contact VIC MARQUES
Regulation Number872.3640
Classification Product Code
DZE  
Date Received12/15/1992
Decision Date 09/21/1995
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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