REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PAST


Device Classification Name

bone grafting material, human source

510(k) Number K080418
Device Name REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PAST
Applicant
REGENERATION TECHNOLOGIES, INC.
11621 research cir.
p.o. box 2650
alachua, 
FL 
32616 -2650

Applicant Contact travis arola
Correspondent
REGENERATION TECHNOLOGIES, INC.
11621 research cir.
p.o. box 2650
alachua, 
FL 
32616 -2650

Correspodent Contact travis arola
Regulation Number 872.3930
Classification Product Code
NUN  
Date Received 02/15/2008
Decision Date 04/30/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

Yes