STERNIC IMPLANT 4.2MM RN, 1.8MM, 8.0MM / 4.1MM RN, 1.8MM, 10.MM / 4.1 MM RN, 1.8MM, 12.0MM / 4.1MM RN, 1.8MM, 14.0MM …


Device Classification Name

implant, endosseous, root-form

510(k) Number K111798
Device Name STERNIC IMPLANT 4.2MM RN, 1.8MM, 8.0MM / 4.1MM RN, 1.8MM, 10.MM / 4.1 MM RN, 1.8MM, 12.0MM / 4.1MM RN, 1.8MM, 14.0MM …
Applicant
STERNGOLD DENTAL LLC.
23 frank mossberg dr
attleboro, 
MA 
02703

Applicant Contact maria rao
Correspondent
STERNGOLD DENTAL LLC.
23 frank mossberg dr
attleboro, 
MA 
02703

Correspodent Contact maria rao
Regulation Number 872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received 06/27/2011
Decision Date 06/01/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No