CERAM-PRIME


codes

Device Classification Name

agent, tooth bonding, resin

510(k) Number K002502
Device Name CERAM-PRIME
Original Applicant
S & C POLYMER GMBH
robert-bosch-str. 5
d-25335
elmshorn, 

DE

Original Contact jurgen engelbrecht
Regulation Number 872.3200
Classification Product Code
KLE  
Date Received 08/14/2000
Decision Date 11/08/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

Type Traditional
Reviewed by Third Party No

Combination Product

No