Dentsply Professional

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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

Dental barriers and sleeves (PEM) (9) HANDPIECE, DIRECT DRIVE, AC-POWERED (EKX) (7) Additively manufactured, preformed, resin denture tooth (PZY) (1) HANDPIECE, AIR-POWERED, DENTAL (EFB) (1)

Premarket Exempt

No Yes

Clear

Lucitone Digital IPN 3D Premium Tooth - D0039063980 Catalog Number : 906398

Device Class : 2

Duns Number: 144140845

Premarket Exempt : Yes

Product Code : PZY

Prescription Use : No

Device Count : 1

MIDWEST® - D00390701L011 Catalog Number :

Device Description : MIDWEST® RDH Freedom® Cordless Prophy System - Lavender. Contains: 1 Basic Syste MIDWEST® RDH Freedom® Cordless Prophy System - Lavender. Contains: 1 Basic System, 20 NUPRO Freedom® Disposable Prophy Angles, 1 Disposa-Shield® Trial Pack.

Device Class : 1

Duns Number: 144140845

Premarket Exempt : No

Product Code : PEM, EKX

Prescription Use : Yes

Device Count : 1

MIDWEST® - D00390702L011 Catalog Number :

Device Description : MIDWEST® RDH Freedom® Cordless Prophy System, Premium System With Carrying Case MIDWEST® RDH Freedom® Cordless Prophy System, Premium System With Carrying Case - Lavender Contains: 3 Sheaths, 200 NUPRO Freedom® Disposable Prophy Angles and 1 Disposa-Shield ® Trial Pack.

Device Class : 1

Duns Number: 144140845

Premarket Exempt : No

Product Code : EKX, PEM

Prescription Use : Yes

Device Count : 1

MIDWEST® - D00390702L031 Catalog Number :

Device Description : MIDWEST® RDH Freedom® Cordless Prophy System, Premium System - Lavender. Contain MIDWEST® RDH Freedom® Cordless Prophy System, Premium System - Lavender. Contains: 3 Sheaths, 200 NUPRO Freedom® Disposable Prophy Angles and 1 Disposa-Shield ® Trial Pack.

Device Class : 1

Duns Number: 144140845

Premarket Exempt : No

Product Code : PEM, EKX

Prescription Use : Yes

Device Count : 1

MIDWEST® - D00390702PK011 Catalog Number :

Device Description : MIDWEST® RDH Freedom® Cordless Prophy System, Premium System With Carrying Case MIDWEST® RDH Freedom® Cordless Prophy System, Premium System With Carrying Case - Pink Contains: 3 Sheaths, 200 NUPRO Freedom® Disposable Prophy Angles and 1 Disposa-Shield ® Trial Pack.

Device Class : 1

Duns Number: 144140845

Premarket Exempt : No

Product Code : EKX, PEM

Prescription Use : Yes

Device Count : 1

MIDWEST® - D00390702PK031 Catalog Number :

Device Description : MIDWEST® RDH Freedom® Cordless Prophy System, Premium System - Pink. Contains: 3 MIDWEST® RDH Freedom® Cordless Prophy System, Premium System - Pink. Contains: 3 Sheaths, 200 NUPRO Freedom® Disposable Prophy Angles and 1 Disposa-Shield ® Trial Pack.

Device Class : 1

Duns Number: 144140845

Premarket Exempt : No

Product Code : PEM, EKX

Prescription Use : Yes

Device Count : 1

Disposa-Shield® - D003907361 Catalog Number :

Device Description : Disposa-Shield® Surface Barrier For Midwest®RDH Freedom® Inner Module Trial Pack Disposa-Shield® Surface Barrier For Midwest®RDH Freedom® Inner Module Trial Pack. Box of 25

Device Class :

Duns Number: 144140845

Premarket Exempt : No

Product Code : EFB, PEM

Prescription Use : Yes

Device Count : 25

Nupro - D00390741L011 Catalog Number :

Device Description : NUPRO Freedom™ with SmartMode™ Technology Cordless Prophy System Basic Kit - Lav NUPRO Freedom™ with SmartMode™ Technology Cordless Prophy System Basic Kit - Lavender - Contains: 1 Cordless Prophy System, 20 Nupro Freedom® Disposable Prophy Angles, 1 Disposa-Shield® Barrier Trial Pack (Polyethylene Barriers)

Device Class : 1

Duns Number: 144140845

Premarket Exempt : No

Product Code : PEM, EKX

Prescription Use : Yes

Device Count : 1

Nupro - D00390741L031 Catalog Number :

Device Description : Nupro Freedom™ with SmartMode™ Technology Cordless Prophy System Premium Kit - L Nupro Freedom™ with SmartMode™ Technology Cordless Prophy System Premium Kit - Lavender. Contains: 1 Cordless Prophy System, 3 Handpiece Sheaths, 200 Nupro Freedom® Disposable Prophy Angles, 500 Disposa-Shield® Barrier Trial Pack (Polyethylene Barriers)

Device Class : 1

Duns Number: 144140845

Premarket Exempt : No

Product Code : PEM, EKX

Prescription Use : Yes

Device Count : 1

Disposa-Shield® - D0039078911 Catalog Number :

Device Description : Disposa-Shield® Disposable Barrier Trial Pack For Cordless Prophy System Inner M Disposa-Shield® Disposable Barrier Trial Pack For Cordless Prophy System Inner Module Contains: 25 Disposable Polyethylene Barriers

Device Class :

Duns Number: 144140845

Premarket Exempt : No

Product Code : PEM

Prescription Use : Yes

Device Count : 25

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