BPA-FREE PIT AND FISSURE SEALANT


Device Classification Name

sealant, pit and fissure, and conditioner

510(k) Number K110058
Device Name BPA-FREE PIT AND FISSURE SEALANT
Applicant
NOVOCOL INC. DBA SEPTODONT AND CONFI-DENTAL PRODUC
416 s. taylor ave
louisville, 
CO 
80027

Applicant Contact cora bracho-troconis
Correspondent
NOVOCOL INC. DBA SEPTODONT AND CONFI-DENTAL PRODUC
416 s. taylor ave
louisville, 
CO 
80027

Correspodent Contact cora bracho-troconis
Regulation Number 872.3765
Classification Product Code
EBC  
Date Received 01/10/2011
Decision Date 03/31/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Abbreviated
Reviewed by Third Party No

Combination Product

No