PROPEL ORTHODONTICS LLC

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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

Setter, Band, Orthodontic (ECR) (5) Driver, Wire, And Bone Drill, Manual (DZJ) (4) Handle, Instrument, Dental (EJB) (1) Orthodontic Vibratory Accessory (OYH) (1)

Premarket Exempt

No Yes

Clear

Propel - 00852673007004 Catalog Number : ASM-20010

Device Description : Perforation Device, Propel XL

Device Class : 2

Duns Number: 117334253

Premarket Exempt : No

Product Code : DZJ

Prescription Use : Yes

Device Count : 1

Propel - 00852673007011 Catalog Number : ASM-20018

Device Description : C-Shaped Vibration Device

Device Class : 1

Duns Number: 117334253

Premarket Exempt : Yes

Product Code : ECR

Prescription Use : Yes

Device Count : 1

Propel - 00852673007028 Catalog Number : ASM-20010-04

Device Description : Assy. Packaged Perforation Device, Contra-Angle

Device Class : 2

Duns Number: 117334253

Premarket Exempt : No

Product Code : DZJ

Prescription Use : Yes

Device Count : 1

Propel - 00852673007035 Catalog Number : ASM-20010-01

Device Description : Assy. Packaged Disposable Drill Tip, Closed

Device Class : 2

Duns Number: 117334253

Premarket Exempt : No

Product Code : DZJ

Prescription Use : Yes

Device Count : 1

Propel - 00852673007042 Catalog Number : ASM-20010-03

Device Description : Propel, Reusable Handle

Device Class : 1

Duns Number: 117334253

Premarket Exempt : Yes

Product Code : EJB

Prescription Use : Yes

Device Count : 1

Propel - 00852673007059 Catalog Number : ASM-20010-02

Device Description : Assy. Packaged Disposable Drill Tip-Open

Device Class : 2

Duns Number: 117334253

Premarket Exempt : No

Product Code : DZJ

Prescription Use : Yes

Device Count : 1

Propel - 00852673007066 Catalog Number : ASM-20022

Device Description : Packaged Mouthpiece, Single, Assy

Device Class : 1

Duns Number: 117334253

Premarket Exempt : Yes

Product Code : ECR

Prescription Use : Yes

Device Count : 1

Propel - 00852673007073 Catalog Number : ASM-20021

Device Description : Packaged C-Shaped Mouthpiece, Tapered, Assy

Device Class : 1

Duns Number: 117334253

Premarket Exempt : Yes

Product Code : OYH, ECR

Prescription Use : Yes

Device Count : 1

Propel - 00852673007080 Catalog Number : ASM-20018-04

Device Description : C-Shaped Vibration Device, Brazil

Device Class : 1

Duns Number: 117334253

Premarket Exempt : Yes

Product Code : ECR

Prescription Use : Yes

Device Count : 1

Propel - 00852673007097 Catalog Number :

Device Description : VPro+

Device Class : 1

Duns Number: 062805389

Premarket Exempt : Yes

Product Code : ECR

Prescription Use : Yes

Device Count : 1

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