ORTHODONTIC SUPPLY & EQUIPMENT COMPANY INC

Address:7851 Airpark Rd Ste 202,GAITHERSBURG,MD,20879,US

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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

Cement, Dental (EMA) (4) Adhesive, Bracket And Tooth Conditioner, Resin (DYH) (3) Agent, Tooth Bonding, Resin (KLE) (3) Material, Tooth Shade, Resin (EBF) (3)

Premarket Exempt

No Yes

Clear

Adhere - 00869843000215 Catalog Number :

Device Description : 9 ml Catalyst Primer for the Adhere™ Orthodontic Bonding System

Device Class : 2

Duns Number: 077801124

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

Adhere - 00869843000222 Catalog Number :

Device Description : Adhere™ Orthodontic Bonding System

Device Class : 2

Duns Number: 077801124

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

Depend-On - 00869843000239 Catalog Number :

Device Description : Depend-On™ Orthodontic Bonding System

Device Class : 2

Duns Number: 077801124

Premarket Exempt : No

Product Code : KLE, EBF, DYH, EMA

Prescription Use : Yes

Device Count : 1

OSE - 00869843000246 Catalog Number :

Device Description : Glass Ionomer Cement

Device Class : 2

Duns Number: 077801124

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

OSE - 00869843000253 Catalog Number :

Device Description : Zinc Phosphate Cement Kit

Device Class : 2

Duns Number: 077801124

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

OSE - 00869843000260 Catalog Number :

Device Description : Zinc Phosphate Cement Powder

Device Class : 2

Duns Number: 077801124

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

OSE - 00869843000277 Catalog Number :

Device Description : POSI-Lock™ Light Cure Flowable Composite Kit

Device Class : 2

Duns Number: 077801124

Premarket Exempt : No

Product Code : KLE, EBF

Prescription Use : Yes

Device Count : 1

OSE - 00869843000284 Catalog Number :

Device Description : POSI-Lock™ Light Cure Flowable Composite Syringe

Device Class : 2

Duns Number: 077801124

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

OSE 8oz. Orthodontic Etching Gel - Blue - 00869843000291 Catalog Number :

Device Class : 2

Duns Number: 077801124

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 1

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