AccessGUDID - DEVICE: Occlusal Reduction Rings Green 2.0mm Refill 50-pack (00359883006457)

GUDID

Device Identifier (DI) Information

Brand Name: Occlusal Reduction Rings Green 2.0mm Refill 50-pack
Version or Model: 692050
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 692050
Company Name: DEN-MAT HOLDINGS, LLC

Primary DI Number: 00359883006457
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 809857704 *Terms of Use

Device Description: Dental occlusal gauge instrument

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:	Yes
Prescription Use (Rx):	Yes
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?
45240	Interproximal/occlusal dental gauge, single-use	A device intended to be used to directly measure the interproximal (adjacent) and/or occlusal (opposing) clearance of a prepared tooth, typically to ensure sufficient space in the development of a dental restoration. The device may be in the form of a flexible tab (e.g., thermoplastic material) available in a variety of standard thicknesses. This is a single-use 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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store at room temperature
Storage Environment Temperature: between 15 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Width: 2.0 Millimeter

Device Record Status

Public Device Record Key: dc8de737-eda1-44e8-8dad-12821e0f6d9a
Public Version Date: March 20, 2025
Public Version Number: 1
DI Record Publish Date: March 12, 2025