TRILUX, Z-TONE, ACRY ROCK


Device Classification Name

denture, plastic, teeth

510(k) Number K022299
Device Name TRILUX, Z-TONE, ACRY ROCK
Original Applicant
RUTHIBRAS IMP. EXP. COM. DE MATERIAIS ODONTOLOGICO
13 red fox ln.
littleton, 
CO 
80127

Original Contact kevin walls
Regulation Number 872.3590
Classification Product Code
ELM  
Date Received 07/16/2002
Decision Date 10/07/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No