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) (5) UNIT, SYRINGE, AIR AND/OR WATER (ECB) (4) VARNISH, CAVITY (LBH) (3) AIRBRUSH (KOJ) (1) Scaler, ultrasonic (ELC) (1)

Premarket Exempt

No Yes

Clear

Sani-Tip® - D0031222101 Catalog Number :

Device Description : Sani-Tip® Disposable Air/Water Syringe Tip. Contents: Standard Regular Kit - 25 Sani-Tip® Disposable Air/Water Syringe Tip. Contents: Standard Regular Kit - 250 Tips and 250 Sani-Shield® Sleeves.

Device Class : 1

Duns Number: 144140845

Premarket Exempt : No

Product Code : ECB, PEM

Prescription Use : Yes

Device Count : 1

Sani-Tip® - D0031222151 Catalog Number :

Device Description : Sani-Tip® Disposable Air/Water Syringe Tip. Contents: Bulk Kit - 1,500 Tips and Sani-Tip® Disposable Air/Water Syringe Tip. Contents: Bulk Kit - 1,500 Tips and 250 Sani-Shield® Sleeves.

Device Class : 1

Duns Number: 144140845

Premarket Exempt : No

Product Code : PEM, ECB

Prescription Use : Yes

Device Count : 1

Sani-Tip® - D0031222181 Catalog Number :

Device Description : Sani-Tip® Disposable Air/Water Syringe Tip. Contents: Mini Regular Kit - 250 Ti Sani-Tip® Disposable Air/Water Syringe Tip. Contents: Mini Regular Kit - 250 Tips and 250 Sani-Shield® Sleeves.

Device Class : 1

Duns Number: 144140845

Premarket Exempt : No

Product Code : ECB, PEM

Prescription Use : Yes

Device Count : 1

Sani-Tip® - D0031222241 Catalog Number :

Device Class : 1

Duns Number: 144140845

Premarket Exempt : No

Product Code : ECB, PEM

Prescription Use : Yes

Device Count : 1

Cavitron® - D0031300021 Catalog Number :

Device Description : Prophy-Jet® Mint Flavored Sodium Bicarbonate Prophy Powder 364g

Device Class : 2

Duns Number: 144140845

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Sani-Shield® - D0031300101 Catalog Number :

Device Description : Sani-Shield® Disposable Barrier for Air/Water Syringes

Device Class :

Duns Number: 144140845

Premarket Exempt : No

Product Code : PEM

Prescription Use : Yes

Device Count : 250

Cavitron® - D0031302031 Catalog Number :

Device Description : Cavitron® JET-Fresh® Mint Flavored Prophy Powder with Aluminimum Trihydroxide 364g

Device Class : 2

Duns Number: 144140845

Premarket Exempt : No

Product Code : KOJ

Prescription Use : Yes

Device Count : 1

NUPRO® - D0031302101 Catalog Number :

Device Description : NUPRO® 5% Sodium Fluoride White Varnish, Patient Dose Kit - Grape. Contents: 50 NUPRO® 5% Sodium Fluoride White Varnish, Patient Dose Kit - Grape. Contents: 50 Patient Doses of 0.4g, 50 Brush applicators and 1 Prophy Grip.

Device Class :

Duns Number: 144140845

Premarket Exempt : No

Product Code : LBH

Prescription Use : Yes

Device Count : 50

NUPRO® - D0031302111 Catalog Number :

Device Description : NUPRO® 5% Sodium Fluoride White Varnish, Patient Dose Kit - Grape. Contents: 100 NUPRO® 5% Sodium Fluoride White Varnish, Patient Dose Kit - Grape. Contents: 100 Patient Doses of 0.4g, 100 Brush applicators and 1 Prophy Grip.

Device Class :

Duns Number: 144140845

Premarket Exempt : No

Product Code : LBH

Prescription Use : Yes

Device Count : 100

NUPRO® - D0031302121 Catalog Number :

Device Description : NUPRO® 5% Sodium Fluoride White Varnish, Grape. Contents: 500 Patient Doses of 0 NUPRO® 5% Sodium Fluoride White Varnish, Grape. Contents: 500 Patient Doses of 0.4g, 500 Brush Applicators, and 3 Prophy Grips.

Device Class :

Duns Number: 144140845

Premarket Exempt : No

Product Code : LBH

Prescription Use : Yes

Device Count : 500

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