AIGIS-SOFT


Device Classification Name

alloy, gold-based noble metal

510(k) Number K024136
Device Name AIGIS-SOFT
Original Applicant
SB LUCIUS, INC.
9778 katella ave. ste. 205
anaheim, 
CA 
92804

Original Contact daekyu chang
Regulation Number 872.3060
Classification Product Code
EJT  
Date Received 12/16/2002
Decision Date 03/10/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No