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

Scaler, ultrasonic (ELC) (10)

Premarket Exempt

No Yes

Clear

Cavitron® - D00388002021 Catalog Number :

Device Description : Cavitron® Built-In a-dec® Ultrasonic Scaler Model G139 (82 GRAY, S/M 360, w/ PWR Cavitron® Built-In a-dec® Ultrasonic Scaler Model G139 (82 GRAY, S/M 360, w/ PWR SPLY) Also contains: Handpiece with swivel cable, Ultrasonic insert, Installation kit.

Device Class : 2

Duns Number: 144140845

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Cavitron® - D00388002031 Catalog Number :

Device Description : Cavitron® integrated systems Built-In a-dec® Ultrasonic Scaler Model G139 (66 GR Cavitron® integrated systems Built-In a-dec® Ultrasonic Scaler Model G139 (66 GRAY, S/M, w/ PWR SPLY) Also contains: Handpiece with swivel cable, Ultrasonic insert, Installation kit.

Device Class : 2

Duns Number: 144140845

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Cavitron® - D00388002041 Catalog Number :

Device Description : Cavitron® integrated systems Built-In a-dec® Ultrasonic Scaler Model G139 (82 GR Cavitron® integrated systems Built-In a-dec® Ultrasonic Scaler Model G139 (82 GRAY, S/M, w/ PWR SPLY) Also contains: Handpiece with swivel cable, Ultrasonic insert, Installation kit.

Device Class : 2

Duns Number: 144140845

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Cavitron® - D00388003011 Catalog Number :

Device Description : Cavitron® integrated systems Built-In Ultrasonic Scaler Model G139- Pelton & Cra Cavitron® integrated systems Built-In Ultrasonic Scaler Model G139- Pelton & Crane (66 GRAY, S/M 360) Also contains: 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® - D00388003021 Catalog Number :

Device Description : Cavitron® integrated systems Built-In Ultrasonic Scaler Model G139- Pelton & Cra Cavitron® integrated systems Built-In Ultrasonic Scaler Model G139- Pelton & Crane (66 GRAY, S/M) Also contains: 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® - D00388004011 Catalog Number :

Device Description : Cavitron® integrated systems Built-In Ultrasonic Scaler Model G139- MidMark (66 Cavitron® integrated systems Built-In Ultrasonic Scaler Model G139- MidMark (66 SURF, S/M 360) Also contains: 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® - D00388004021 Catalog Number :

Device Description : Cavitron® integrated systems Built-In Ultrasonic Scaler Model G139- MidMark (157 Cavitron® integrated systems Built-In Ultrasonic Scaler Model G139- MidMark (157 SURF, S/M 360) Also contains: 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® - D00388005011 Catalog Number :

Device Description : Cavitron® Integrated Systems Built-In Ultrasonic Scaling System for Intego (52.7 Cavitron® Integrated Systems Built-In Ultrasonic Scaling System for Intego (52.75" Gray, Intego). Also contains: Handpiece with swivel cable, Ultrasonic insert, Installation kit.

Device Class : 2

Duns Number: 144140845

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Cavitron® - D00388005021 Catalog Number :

Device Description : Cavitron® Integrated Systems Built-In Ultrasonic Scaling System for Intego (52.7 Cavitron® Integrated Systems Built-In Ultrasonic Scaling System for Intego (52.75" Gray, Intego) with Retro Fit Kit. Also contains: Handpiece with swivel cable, Ultrasonic insert, Installation kit.

Device Class : 2

Duns Number: 144140845

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Cavitron® - D00388007011 Catalog Number :

Device Description : Cavitron® integrated systems Built-In Module Assembly - Spare Part Kit MidMark Model G139

Device Class : 2

Duns Number: 144140845

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

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