DIMENSION GARANT L, DIMENSION GARANT L QUICK


Device Classification Name

material, impression

510(k) Number K000588
Device Name DIMENSION GARANT L, DIMENSION GARANT L QUICK
Original Applicant
ESPE DENTAL AG
espe platz
seefeld, bavaria, 

DE

d-82229

Original Contact andreas petermann
Regulation Number 872.3660
Classification Product Code
ELW  
Date Received 02/22/2000
Decision Date 03/30/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

Type Traditional
Reviewed by Third Party No

Combination Product

No