BIO-97


Device Classification Name

alloy, gold-based noble metal

510(k) Number K991901
Device Name BIO-97
Applicant
JENERIC/PENTRON, INC.
53 north plains industrial rd.
p.o. box 724
wallingford, 
CT 
06492 -0724

Applicant Contact murray g gamberg
Correspondent
JENERIC/PENTRON, INC.
53 north plains industrial rd.
p.o. box 724
wallingford, 
CT 
06492 -0724

Correspodent Contact murray g gamberg
Regulation Number 872.3060
Classification Product Code
EJT  
Date Received 06/04/1999
Decision Date 09/07/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No