ALL-ETCH, ALL- ETCH WITH BAC; UNI- ETCH, UNI- ETCH WITH BAC; ETCH- 37, ETCH- 37 WITH BAC; DARK- ETCH, DARK ETCH (BLUE- E

Agent, Tooth Bonding, Resin

BISCO, INC.

The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for All-etch, All- Etch With Bac; Uni- Etch, Uni- Etch With Bac; Etch- 37, Etch- 37 With Bac; Dark- Etch, Dark Etch (blue- E.

Pre-market Notification Details

Device IDK101485
510k NumberK101485
Device Name:ALL-ETCH, ALL- ETCH WITH BAC; UNI- ETCH, UNI- ETCH WITH BAC; ETCH- 37, ETCH- 37 WITH BAC; DARK- ETCH, DARK ETCH (BLUE- E
ClassificationAgent, Tooth Bonding, Resin
Applicant BISCO, INC. 1100 WEST IRVING PARK RD. Schaumburg,  IL  60193
ContactMichelle Schultz- Taing
CorrespondentMichelle Schultz- Taing
BISCO, INC. 1100 WEST IRVING PARK RD. Schaumburg,  IL  60193
Product CodeKLE  
CFR Regulation Number872.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-05-28
Decision Date2010-08-26
Summary:summary

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