HC-BIOS DENTAL IMPLANT


Device Classification Name

implant, endosseous, root-form

510(k) Number K110425
Device Name HC-BIOS DENTAL IMPLANT
Applicant
HUNG CHUN BIO-S CO., LTD.
no.45, minsheng rd
danshui town
taipei county, 

TW

251

Applicant Contact michael lee
Correspondent
HUNG CHUN BIO-S CO., LTD.
no.45, minsheng rd
danshui town
taipei county, 

TW

251

Correspodent Contact michael lee
Regulation Number 872.3640
Classification Product Code
DZE  
Date Received 02/14/2011
Decision Date 07/27/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No