Fiber Optic Probe For use with DENTSPLY Curing lights - Curing Probe, 13mm - 80° angle - DENTSPLY INTERNATIONAL INC.

Duns Number:083235549

Device Description: Curing Probe, 13mm - 80° angle

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More Product Details

Catalog Number

644714

Brand Name

Fiber Optic Probe For use with DENTSPLY Curing lights

Version/Model Number

644714

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 05, 2019

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)

-

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

EBZ

Product Code Name

ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION

Device Record Status

Public Device Record Key

30eeb26a-aebb-4dd1-840b-c48401a5a6fe

Public Version Date

October 03, 2022

Public Version Number

3

DI Record Publish Date

September 21, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DENTSPLY INTERNATIONAL INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 123
2 A medical device with a moderate to high risk that requires special controls. 397
U Unclassified 2