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) (10)

Premarket Exempt

No Yes

Clear

Cavitron® - D00381351031 Catalog Number :

Device Description : Cavitron® Built-In Ultrasonic Model G90 Dealer Kit SPS (82 GRY). Also contains: Cavitron® Built-In Ultrasonic Model G90 Dealer Kit SPS (82 GRY). Also contains: Steri-Mate® Handpiece with Swivel cable, Ultrasonic insert, and Installation kit.

Device Class : 2

Duns Number: 144140845

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Cavitron® - D00381351041 Catalog Number :

Device Description : Cavitron® Built-In Ultrasonic Model G90 Dealer Kit SPS (82 SURF). Also contains: Cavitron® Built-In Ultrasonic Model G90 Dealer Kit SPS (82 SURF). Also contains: Steri-Mate® Handpiece with Swivel cable, Ultrasonic insert, and Installation kit.

Device Class : 2

Duns Number: 144140845

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Cavitron® - D00381352011 Catalog Number :

Device Description : Cavitron® Built-In Ultrasonic Scaler Model G90 (66 GRY). Also contains: Steri-Ma Cavitron® Built-In Ultrasonic Scaler Model G90 (66 GRY). Also contains: Steri-Mate® Handpiece with Swivel cable, Ultrasonic insert,Installation kit, and Power Supply.

Device Class : 2

Duns Number: 144140845

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Cavitron® - D00381352021 Catalog Number :

Device Description : Cavitron® Built-In Ultrasonic Scaler Model G90 (66 SURF). Also contains: Steri-M Cavitron® Built-In Ultrasonic Scaler Model G90 (66 SURF). Also contains: Steri-Mate® Handpiece with Swivel cable, Ultrasonic insert,Installation kit, and Power Supply.

Device Class : 2

Duns Number: 144140845

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Cavitron® - D00381352031 Catalog Number :

Device Description : Cavitron® Built-In Ultrasonic Scaler Model G90 (82 GRAY). Also contains: Steri-M Cavitron® Built-In Ultrasonic Scaler Model G90 (82 GRAY). Also contains: Steri-Mate® Handpiece with Swivel cable, Ultrasonic insert,Installation kit, and Power Supply.

Device Class : 2

Duns Number: 144140845

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Cavitron® - D00381352041 Catalog Number :

Device Description : Cavitron® Built-In Ultrasonic Scaler Model G90 (82 SURF). Also contains: Steri-M Cavitron® Built-In Ultrasonic Scaler Model G90 (82 SURF). Also contains: Steri-Mate® Handpiece with Swivel cable, Ultrasonic insert,Installation kit, and Power Supply.

Device Class : 2

Duns Number: 144140845

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Cavitron® - D003815001 Catalog Number :

Device Description : Bellissima® FOCUSED SPRAY® PowerLINE® Ultrasonic Insert 30K (B) FSI®-PWR-3

Device Class : 2

Duns Number: 144140845

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Cavitron® - D003815011 Catalog Number :

Device Description : Bellissima® FOCUSED SPRAY® PowerLINE® Ultrasonic Insert 30K (B) FSI®-PWR-10

Device Class : 2

Duns Number: 144140845

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Cavitron® - D003815021 Catalog Number :

Device Description : Bellissima® FOCUSED SPRAY® PowerLINE® Ultrasonic Insert 30K (B) FSI®-PWR-100

Device Class : 2

Duns Number: 144140845

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Cavitron® - D003815031 Catalog Number :

Device Description : Bellissima® FOCUSED SPRAY® PowerLINE® Ultrasonic Insert 30K (B) FSI®-PWR-1000

Device Class : 2

Duns Number: 144140845

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

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