Cavitron®

GUDID D00381800011

Cavitron® SPS™ Self Install Ultrasonic Scaler with Cavitron® Steri-Mate® Handpiece with Swivel 115V Power Cord - 6.5 GRY Hdpc Cable

Dentsply Professional

Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system

• Primary Device ID: D00381800011
• NIH Device Record Key: 1553d51d-a7d5-4abb-85ae-aa77d1e431bd
• Commercial Distribution Discontinuation: 2023-05-10
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Cavitron®
• Version Model Number: 8180001
• Company DUNS: 144140845
• Company Name: Dentsply Professional
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)989-8825
• Email: xx@xx.xx
• Phone: +1(800)989-8825
• Email: xx@xx.xx
• Phone: +1(800)989-8825
• Email: xx@xx.xx
• Phone: +1(800)989-8825
• Email: xx@xx.xx
• Phone: +1(800)989-8825
• Email: xx@xx.xx
• Phone: +1(800)989-8825
• Email: xx@xx.xx
• Phone: +1(800)989-8825
• Email: xx@xx.xx
• Phone: +1(800)989-8825
• Email: xx@xx.xx
• Phone: +1(800)989-8825
• Email: xx@xx.xx
• Phone: +1(800)989-8825
• Email: xx@xx.xx
• Phone: +1(800)989-8825
• Email: xx@xx.xx
• Phone: +1(800)989-8825
• Email: xx@xx.xx

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Atmospheric limitations 500 to 1060 hPa. Do not place on or next to a radiator or other heat source.
• Special Storage Condition, Specify: Between 0 and 0 *Atmospheric limitations 500 to 1060 hPa. Do not place on or next to a radiator or other heat source.
• Special Storage Condition, Specify: Between 0 and 0 *Atmospheric limitations 500 to 1060 hPa. Do not place on or next to a radiator or other heat source.
• Special Storage Condition, Specify: Between 0 and 0 *Atmospheric limitations 500 to 1060 hPa. Do not place on or next to a radiator or other heat source.
• Special Storage Condition, Specify: Between 0 and 0 *Atmospheric limitations 500 to 1060 hPa. Do not place on or next to a radiator or other heat source.
• Special Storage Condition, Specify: Between 0 and 0 *Atmospheric limitations 500 to 1060 hPa. Do not place on or next to a radiator or other heat source.
• Special Storage Condition, Specify: Between 0 and 0 *Atmospheric limitations 500 to 1060 hPa. Do not place on or next to a radiator or other heat source.
• Special Storage Condition, Specify: Between 0 and 0 *Atmospheric limitations 500 to 1060 hPa. Do not place on or next to a radiator or other heat source.
• Special Storage Condition, Specify: Between 0 and 0 *Atmospheric limitations 500 to 1060 hPa. Do not place on or next to a radiator or other heat source.
• Special Storage Condition, Specify: Between 0 and 0 *Atmospheric limitations 500 to 1060 hPa. Do not place on or next to a radiator or other heat source.
• Special Storage Condition, Specify: Between 0 and 0 *Atmospheric limitations 500 to 1060 hPa. Do not place on or next to a radiator or other heat source.
• Special Storage Condition, Specify: Between 0 and 0 *Atmospheric limitations 500 to 1060 hPa. Do not place on or next to a radiator or other heat source.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D00381800011 [Primary]

FDA Product Code

• ELC: Scaler, ultrasonic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2023-05-11
• Device Publish Date: 2016-09-23

On-Brand Devices [Cavitron®]

• D003902601: Cavitron® Insert Sterilization Cassette
• D00382703131: Cavitron 300 Series Ultrasonic Scaling System Unit 113v
• D00382703121: Cavitron 300 Series Ultrasonic Scaling System Unit 240V
• D00382703111: Cavitron 300 Series Ultrasonic Scaling System Unit 220/240V
• D00377602051: Prophy-Jet® Air Polishing Nozzle, Steri-Pak®. Contains: 3 Nozzles and 1 Cleaning Tool.
• D00377602011: Prophy-Jet® Air Polishing Nozzle. Contains: 1 Cleaning Tool.
• D003901481: Cavitron® Select™ Reservoir Bottle (G123)
• D003901471: Cavitron® Select™ Reservoir Pump (Export)
• D003901461: Cavitron® Select™ Reservoir Pump (G123)
• D003815141: Bellissima® FOCUSED SPRAY® slimLINE® Ultrasonic Insert 30K (B) FSI®-SLI® 2-Pack. Contains:
• D003815131: Bellissima® FOCUSED SPRAY® slimLINE® Ultrasonic Insert 30K (B) FSI®-SLI® 3-Pack. Contains:
• D003815121: Bellissima® FOCUSED SPRAY® slimLINE® Ultrasonic Insert 30K (B) FSI®-SLI®-10L
• D003815111: Bellissima® FOCUSED SPRAY® slimLINE® Ultrasonic Insert 30K (B) FSI®-SLI®-10R
• D003815101: Bellissima® FOCUSED SPRAY® slimLINE® Ultrasonic Insert 30K (B) FSI®-SLI®-10S
• D003815031: Bellissima® FOCUSED SPRAY® PowerLINE® Ultrasonic Insert 30K (B) FSI®-PWR-1000
• D003815021: Bellissima® FOCUSED SPRAY® PowerLINE® Ultrasonic Insert 30K (B) FSI®-PWR-100
• D003815011: Bellissima® FOCUSED SPRAY® PowerLINE® Ultrasonic Insert 30K (B) FSI®-PWR-10
• D003815001: Bellissima® FOCUSED SPRAY® PowerLINE® Ultrasonic Insert 30K (B) FSI®-PWR-3
• D00381350041: Cavitron® a-dec® Built-In Ultrasonic Scaler Model G90 (82 SURF). Also contains: Steri-Mate® H
• D00382500011: Cavitron® touch™ Ultrasonic Scaler and Cavitron® Handpiece 115V-DOM
• D00381800021: Cavitron® SPS™ Self Install Ultrasonic Scaler with Cavitron® Steri-Mate® Handpiece with Swi
• D00381800011: Cavitron® SPS™ Self Install Ultrasonic Scaler with Cavitron® Steri-Mate® Handpiece with Swi
• D00381614261: Cavitron® touch™ Package. Contains: Cavitron Touch™ Ultrasonic Scaling System, Steri-Mate®
• D003812961: Cavitron® Surface Mount Ultrasonic Scaler Model G98A Also contains: Steri-Mate® Handpiece with
• D00381296021: Cavitron® Surface Mount Ultrasonic Scaler Model G98A Also contains: Steri-Mate® Handpiece with
• D00381296011: Cavitron® Surface Mount Ultrasonic Scaler Model G98A Also contains: Steri-Mate® Handpiece with
• D00381295021: Cavitron® Built-In Ultrasonic Scaler G90 Also contains: Steri-Mate® Handpiece with Swivel, Ult