DELIKIT PUTTY, DELIKIT HEAVY BODY, DELIKIT LIGHT BODY


Device Classification Name

material, impression

510(k) Number K103346
Device Name DELIKIT PUTTY, DELIKIT HEAVY BODY, DELIKIT LIGHT BODY
Applicant
SHERPA KOREA
56b shadowbrook dr
hudson, 
NH 
03051

Applicant Contact raymond kelly
Correspondent
SHERPA KOREA
56b shadowbrook dr
hudson, 
NH 
03051

Correspodent Contact raymond kelly
Regulation Number 872.3660
Classification Product Code
ELW  
Date Received 11/15/2010
Decision Date 02/11/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No