Bite Dx Occlusal Pain Diagnostic Instruments - While competitive products work well to identify - PRACTICON, INC.

Duns Number:119193803

Device Description: While competitive products work well to identify fractures and to isolate pain associated While competitive products work well to identify fractures and to isolate pain associated with a single cusp, their small size and hard plastic construction slip around and are inadequate for diagnosing chewing pain unrelated to cracked teeth. The Bite Dx Occlusal Pain Diagnostic Instrument allows the patient to bite down onto soft, non-slip elastomer pads with all cusps of a single tooth at one time to detect chewing pain on all types of teeth. Helps diagnose PDL inflammation and the spread of pulpitis to the apical ligament, in addition to cracks. Tough polypropylene handle also features a traditional pyramid-shaped end for cusp fracture detection. Fully autoclavable

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More Product Details

Catalog Number

71-36615

Brand Name

Bite Dx Occlusal Pain Diagnostic Instruments

Version/Model Number

7136615

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

DZN

Product Code Name

Instruments, Dental Hand

Device Record Status

Public Device Record Key

c93de254-9254-41b1-8241-b03e4be74c40

Public Version Date

August 20, 2018

Public Version Number

1

DI Record Publish Date

July 19, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PRACTICON, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 93
2 A medical device with a moderate to high risk that requires special controls. 2