ENDOBON XENOGRAFT GRANULES


Device Classification Name

bone grafting material, synthetic

510(k) Number K110449
Device Name ENDOBON XENOGRAFT GRANULES
Applicant
BIOMET 3I
4555 riverside drive
palm beach gardens, 
FL 
33410

Applicant Contact martha i garay
Correspondent
BIOMET 3I
4555 riverside drive
palm beach gardens, 
FL 
33410

Correspodent Contact martha i garay
Regulation Number 872.3930
Classification Product Code
LYC  
Date Received 02/16/2011
Decision Date 05/13/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No