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

SEALANT, PIT AND FISSURE, AND CONDITIONER (EBC) (8) Dental barriers and sleeves (PEM) (1) HANDPIECE, AIR-POWERED, DENTAL (EFB) (1) MATERIAL, TOOTH SHADE, RESIN (EBF) (1) VARNISH, CAVITY (LBH) (1)

Premarket Exempt

No Yes

Clear

NUPRO® - D0031303281 Catalog Number :

Device Description : NUPRO® 5% Sodium Fluoride White Varnish, Patient Dose Kit - Raspberry. Contents: NUPRO® 5% Sodium Fluoride White Varnish, Patient Dose Kit - Raspberry. Contents: Integrated Brush, 500 Patient Doses of 0.4g.

Device Class :

Duns Number: 144140845

Premarket Exempt : No

Product Code : LBH

Prescription Use : Yes

Device Count : 500

DELTON® - D00321021 Catalog Number :

Device Description : DELTON® Pit & Fissure Sealant Contents: 2 Etching Liquid of 7 ml.

Device Class :

Duns Number: 144140845

Premarket Exempt : No

Product Code : EBC

Prescription Use : Yes

Device Count : 2

DELTON® - D00321031 Catalog Number :

Device Description : EZ Etch 34% Etchant Gel. Contains: 2 Syringes (3 mL each) and 25 Tips.

Device Class : 2

Duns Number: 144140845

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

DELTON® - D00326951 Catalog Number :

Device Description : DELTON® Pit & Fissure Sealant Direct Delivery System Light Curing Clear. Contain DELTON® Pit & Fissure Sealant Direct Delivery System Light Curing Clear. Contains: 50 Cartridges - 4 ml

Device Class :

Duns Number: 144140845

Premarket Exempt : No

Product Code : EBC

Prescription Use : Yes

Device Count : 50

DELTON® - D00326961 Catalog Number :

Device Description : DELTON® Pit & Fissure Sealant Direct Delivery System Light Curing Opaque. Contai DELTON® Pit & Fissure Sealant Direct Delivery System Light Curing Opaque. Contains: 50 Cartridges - 4 ml

Device Class :

Duns Number: 144140845

Premarket Exempt : No

Product Code : EBC

Prescription Use : Yes

Device Count : 50

DELTON® - D003279651 Catalog Number :

Device Description : DELTON® Regular Kit Light Curing Pit and Fissure Sealant, Clear. Contents: 2 se DELTON® Regular Kit Light Curing Pit and Fissure Sealant, Clear. Contents: 2 sealant bottles of 2.mL, Etchant bottle of 7 mL, Applicator with Tubes, Disposable Mixing Trays.

Device Class : 2

Duns Number: 144140845

Premarket Exempt : No

Product Code : EBC

Prescription Use : Yes

Device Count : 1

DELTON® - D003279751 Catalog Number :

Device Description : DELTON® Regular Kit Light Curing Pit & Fissure Sealant, Opaque. Contents: 2 sea DELTON® Regular Kit Light Curing Pit & Fissure Sealant, Opaque. Contents: 2 sealant bottles of 2.mL, Etchant bottle of 7 mL, Applicator with Tubes, Disposable Mixing Trays.

Device Class : 2

Duns Number: 144140845

Premarket Exempt : No

Product Code : EBC

Prescription Use : Yes

Device Count : 1

DELTON® - D00328941 Catalog Number :

Device Description : DELTON® PLUS Pit & Fissure Sealant with FLUORIDE Direct Delivery System Light Cu DELTON® PLUS Pit & Fissure Sealant with FLUORIDE Direct Delivery System Light Curing, Opaque. Contents: 1 DDS Autoclavable Applicator, 50 Cartridges of 4 ml Sealant, EZ Etch Syringe of 3ml, 25 Etch Brush Tips.

Device Class : 2

Duns Number: 144140845

Premarket Exempt : No

Product Code : EBC

Prescription Use : Yes

Device Count : 1

DELTON® - D00328961 Catalog Number :

Device Description : DELTON® PLUS Pit & Fissure Sealant with Fluoride Direct Delivery System Light Cu DELTON® PLUS Pit & Fissure Sealant with Fluoride Direct Delivery System Light Curing, Opaque. Contents: 50 DDS Cartridges of 4 ml.

Device Class :

Duns Number: 144140845

Premarket Exempt : No

Product Code : EBC

Prescription Use : Yes

Device Count : 50

DELTON® - D0033101011 Catalog Number :

Device Description : DELTON® FS+ FLOWABLE Pit & Fissure Sealant with FLUORIDE Light Curing Opaque. Al DELTON® FS+ FLOWABLE Pit & Fissure Sealant with FLUORIDE Light Curing Opaque. Also contains: Delton® Syringes, EZ Etch Syringe, EZ Tips, and Syringe Sleeves.

Device Class : 1

Duns Number: 144140845

Premarket Exempt : No

Product Code : EBC, PEM, EFB

Prescription Use : Yes

Device Count : 1

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