Cavitron® - SofTip™ Ultrasonic Implant Insert. Also contains: - Dentsply Professional

Duns Number:144140845

Device Description: SofTip™ Ultrasonic Implant Insert. Also contains: Prophy Tips, Tip Wool.

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More Product Details

Catalog Number

-

Brand Name

Cavitron®

Version/Model Number

90411

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

ELC

Product Code Name

Scaler, ultrasonic

Device Record Status

Public Device Record Key

3fc2c9c6-bfdd-4513-8c6e-32fb37e8393f

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DENTSPLY PROFESSIONAL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 13
2 A medical device with a moderate to high risk that requires special controls. 156