FLUOR-ETCH GEL ETCHANT

Sealant, Pit And Fissure, And Conditioner

TELEDYNE, INC.

The following data is part of a premarket notification filed by Teledyne, Inc. with the FDA for Fluor-etch Gel Etchant.

Pre-market Notification Details

Device IDK862695
510k NumberK862695
Device Name:FLUOR-ETCH GEL ETCHANT
ClassificationSealant, Pit And Fissure, And Conditioner
Applicant TELEDYNE, INC. 1550 GREENLEAF AVE. Elk Grove Village,  IL  60007
ContactJohn Washburn
CorrespondentJohn Washburn
TELEDYNE, INC. 1550 GREENLEAF AVE. Elk Grove Village,  IL  60007
Product CodeEBC  
CFR Regulation Number872.3765 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-07-15
Decision Date1986-07-31

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