SYNTEC DENTAL IMPLANT


Device Classification Name

implant, endosseous, root-form

510(k) Number K111189
Device Name SYNTEC DENTAL IMPLANT
Applicant
SYNTEC SCIENTIFIC CORP.
3f1. 96 chung hsiao e. rd.
sec. 3
taipei city, 

TW

106

Applicant Contact chia-ching lee
Correspondent
SYNTEC SCIENTIFIC CORP.
3f1. 96 chung hsiao e. rd.
sec. 3
taipei city, 

TW

106

Correspodent Contact chia-ching lee
Regulation Number 872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received 04/28/2011
Decision Date 12/20/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No