ADD-ON CONDYLE

Device Classification Name

prosthesis, condyle, mandibular, temporary

510(k) Number K002790
Device Name ADD-ON CONDYLE
Original Applicant
WALTER LORENZ SURGICAL, INC.
11520 tradeport dr.
jacksonville, 
FL 
32218 -2480

Original Contact trevor byrd
Regulation Number 872.4770
Classification Product Code
NEI  
Date Received 09/07/2000
Decision Date 08/06/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

Type Traditional
Reviewed by Third Party No

Combination Product

No