SEITY 37% PHOSPHORIC ACID ETCHANT GEL


Device Classification Name

agent, tooth bonding, resin

510(k) Number K112597
Device Name SEITY 37% PHOSPHORIC ACID ETCHANT GEL
Applicant
MYCONE DENTAL SUPPLY CO., INC.
616 hollywood ave.
cherry hill, 
NJ 
08002

Applicant Contact william evans
Correspondent
MYCONE DENTAL SUPPLY CO., INC.
616 hollywood ave.
cherry hill, 
NJ 
08002

Correspodent Contact william evans
Regulation Number 872.3200
Classification Product Code
KLE  
Date Received 09/07/2011
Decision Date 12/07/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No