AccessGUDID - DEVICE: Bite Dx Occlusal Pain Diagnostic Instruments (00723896008836)

GUDID

Device Identifier (DI) Information

Brand Name: Bite Dx Occlusal Pain Diagnostic Instruments
Version or Model: 7136615
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 71-36615
Company Name: PRACTICON, INC.

Primary DI Number: 00723896008836
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 119193803 *Terms of Use

Device Description: 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

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35812	Dental surgical probe, reusable	A slender, rod-like, hand-held manual dental surgical instrument intended to be used to explore, measure and/or perform therapeutic procedures during various types of dental surgical intervention. The distal end may be needle-like, hooked, or blunt; it is made of flexible or rigid metallic and/or synthetic polymer material and it may have scaled markings for measurements. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DZN	Instruments, Dental Hand

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c93de254-9254-41b1-8241-b03e4be74c40
Public Version Date: January 20, 2023
Public Version Number: 2
DI Record Publish Date: July 19, 2018