SELECT DEFENSE DENTAL PIT AND FISSURE SEALANT

Sealant, Pit And Fissure, And Conditioner

CLASSONE ORTHODONTICS, INC.

The following data is part of a premarket notification filed by Classone Orthodontics, Inc. with the FDA for Select Defense Dental Pit And Fissure Sealant.

Pre-market Notification Details

Device IDK093059
510k NumberK093059
Device Name:SELECT DEFENSE DENTAL PIT AND FISSURE SEALANT
ClassificationSealant, Pit And Fissure, And Conditioner
Applicant CLASSONE ORTHODONTICS, INC. 5064 50TH ST. Lubbock,  TX  79414
ContactJudy Ribordy
CorrespondentJudy Ribordy
CLASSONE ORTHODONTICS, INC. 5064 50TH ST. Lubbock,  TX  79414
Product CodeEBC  
CFR Regulation Number872.3765 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-09-30
Decision Date2010-02-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00858290006574 K093059 000
00858290006567 K093059 000
00858290006536 K093059 000
00858290006529 K093059 000
D8281330231 K093059 000
D8281330229 K093059 000

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