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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) (8) Adhesive, Bracket And Tooth Conditioner, Resin (DYH) (2)

Premarket Exempt

No Yes

Clear

OrthoFlow® - 00817645020009 Catalog Number : 904R

Device Description : OrthoFlow® - Indirect Bond 1.5g (Indirect Bonding)

Device Class : 2

Duns Number: 081365847

Premarket Exempt : Yes

Product Code : DYH

Prescription Use : Yes

Device Count : 1

OrthoMax® - 00817645020016 Catalog Number : 905R

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

Device Class : 2

Duns Number: 081365847

Premarket Exempt : Yes

Product Code : DYH

Prescription Use : Yes

Device Count : 1

Lucid-Lok™ - 00817645020023 Catalog Number : 20320-1

Device Description : Lucid-Lok™ Composite Clearlet (Pack of 10)

Device Class : 2

Duns Number: 081365847

Premarket Exempt : Yes

Product Code : DYW

Prescription Use : Yes

Device Count : 1

Lucid-Lok™ - 00817645020030 Catalog Number : 20301

Device Description : Lucid-Lok™ .022 Composite Bracket 5 Set Carousel w/Metal Molar Tubes

Device Class : 2

Duns Number: 081365847

Premarket Exempt : Yes

Product Code : DYW

Prescription Use : Yes

Device Count : 1

Lucid-Lok™ - 00817645020047 Catalog Number : 20302

Device Description : Lucid-Lok™ .022 Composite Bracket Set w/Metal Molar Tubes

Device Class : 2

Duns Number: 081365847

Premarket Exempt : Yes

Product Code : DYW

Prescription Use : Yes

Device Count : 1

Lucid-Lok™ - 00817645020054 Catalog Number : 20303

Device Description : Lucid-Lok™ UL1 Central .022 Composite Bracket

Device Class : 2

Duns Number: 081365847

Premarket Exempt : Yes

Product Code : DYW

Prescription Use : Yes

Device Count : 1

Lucid-Lok™ - 00817645020061 Catalog Number : 20304

Device Description : Lucid-Lok™ UR1 Central .022 Composite Bracket

Device Class : 2

Duns Number: 081365847

Premarket Exempt : Yes

Product Code : DYW

Prescription Use : Yes

Device Count : 1

Lucid-Lok™ - 00817645020078 Catalog Number : 20305

Device Description : Lucid-Lok™ UL2 Lateral .022 Composite Bracket

Device Class : 2

Duns Number: 081365847

Premarket Exempt : Yes

Product Code : DYW

Prescription Use : Yes

Device Count : 1

Lucid-Lok™ - 00817645020085 Catalog Number : 20306

Device Description : Lucid-Lok™ UR2 Lateral .022 Composite Bracket

Device Class : 2

Duns Number: 081365847

Premarket Exempt : Yes

Product Code : DYW

Prescription Use : Yes

Device Count : 1

Lucid-Lok™ - 00817645020092 Catalog Number : 20307

Device Description : Lucid-Lok™ UL3 Cuspid .022 Composite Bracket w/Hook

Device Class : 2

Duns Number: 081365847

Premarket Exempt : Yes

Product Code : DYW

Prescription Use : Yes

Device Count : 1

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