Dentsply Professional

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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

Scaler, ultrasonic (ELC) (9) Dental barriers and sleeves (PEM) (1) HANDPIECE, AIR-POWERED, DENTAL (EFB) (1) SEALANT, PIT AND FISSURE, AND CONDITIONER (EBC) (1)

Premarket Exempt

No Yes

Clear

DELTON® - D0033102011 Catalog Number :

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

Device Class : 1

Duns Number: 144140845

Premarket Exempt : No

Product Code : EBC, EFB, PEM

Prescription Use : Yes

Device Count : 1

SoftTip™ - D0033800591 Catalog Number :

Device Description : SofTip Disposable Prophy Tips

Device Class :

Duns Number: 144140845

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 100

Cavitron® - D00361201021 Catalog Number :

Device Description : Classic P Ultrasonic Insert 25K P-3

Device Class : 2

Duns Number: 144140845

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Cavitron® - D00361201081 Catalog Number :

Device Description : Classic P Ultrasonic Insert 25K P-10

Device Class : 2

Duns Number: 144140845

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Cavitron® - D00361217021 Catalog Number :

Device Description : Thru Flow® Ultrasonic Insert 25K TFI®-3

Device Class : 2

Duns Number: 144140845

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Cavitron® - D00361217081 Catalog Number :

Device Description : Thru Flow® Ultrasonic Insert 25K TFI®-10

Device Class : 2

Duns Number: 144140845

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Cavitron® - D00361220011 Catalog Number :

Device Description : Thru Flow® Ultrasonic Insert 25K TFI®-1000

Device Class : 2

Duns Number: 144140845

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Cavitron® - D003637401 Catalog Number :

Device Description : JET Air Polishing Insert. Contains: 1 Insert, 1 Cleaning Tool, 1 Receptacle

Device Class : 2

Duns Number: 144140845

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Cavitron® - D00363741021 Catalog Number :

Device Description : Thru Flow™ Ultrasonic Insert 30K TFI®-3

Device Class : 2

Duns Number: 144140845

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Cavitron® - D00363741061 Catalog Number :

Device Description : Thru Flow™ Ultrasonic Insert 30K TFI®-10

Device Class : 2

Duns Number: 144140845

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

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