Six Month Smiles

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Bracket, Plastic, Orthodontic (DYW) (5) Adhesive, Bracket And Tooth Conditioner, Resin (DYH) (3) Aligner, Sequential (NXC) (1)

Premarket Exempt

No Yes

Clear

Lucid-Lok™ - 00817645020108 Catalog Number : 20308

Device Description : Lucid-Lok™ UR3 Cuspid .022 Composite Bracket w/Hook

Device Class : 2

Duns Number: 081365847

Premarket Exempt : Yes

Product Code : DYW

Prescription Use : Yes

Device Count : 1

Lucid-Lok™ - 00817645020115 Catalog Number : 20311

Device Description : Lucid-Lok™ LR1/2 and LL1/2 .022 Composite Bracket

Device Class : 2

Duns Number: 081365847

Premarket Exempt : Yes

Product Code : DYW

Prescription Use : Yes

Device Count : 1

Lucid-Lok™ - 00817645020122 Catalog Number : 20312

Device Description : Lucid-Lok™ LL3 Cuspid .022 Composite Bracket w/Hook

Device Class : 2

Duns Number: 081365847

Premarket Exempt : Yes

Product Code : DYW

Prescription Use : Yes

Device Count : 1

Lucid-Lok™ - 00817645020139 Catalog Number : 20313

Device Description : Lucid-Lok™ LR3 Cuspid .022 Composite Bracket w/Hook

Device Class : 2

Duns Number: 081365847

Premarket Exempt : Yes

Product Code : DYW

Prescription Use : Yes

Device Count : 1

Lucid-Lok™ - 00817645020146 Catalog Number : 20321

Device Description : Lucid-Lok™ Universal 4/5 Bicuspid .022 Composite Bracket w/Hook

Device Class : 2

Duns Number: 081365847

Premarket Exempt : Yes

Product Code : DYW

Prescription Use : Yes

Device Count : 1

OrthoMax® - 00817645020160 Catalog Number : 06R

Device Description : OrthoMax® - Direct Bond 5g (Non Flouride)

Device Class : 2

Duns Number: 081365847

Premarket Exempt : Yes

Product Code : DYH

Prescription Use : Yes

Device Count : 1

6MS Aligners - 00817645020177 Catalog Number :

Device Description : Dental Aligners

Device Class : 2

Duns Number: 081365847

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Assure Plus - 00817645020184 Catalog Number :

Device Description : Assure Plus 2ml (Plus2ml)

Device Class : 2

Duns Number: 081365847

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

Porcelain Conditioner - 00817645020191 Catalog Number :

Device Description : Porcelain Conditioner

Device Class : 2

Duns Number: 081365847

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

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