AccessGUDID - DEVICE: iNterra™ iNoffice Nightguard (D00261D0301)

GUDID

Device Identifier (DI) Information

Brand Name: iNterra™ iNoffice Nightguard
Version or Model: 61D030
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 61D030
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D00261D0301
Issuing Agency: HIBCC
Commercial Distribution End Date: December 15, 2022
Device Count: 6
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: iNterra™ iNoffice Nightguard Refill Package, Medium Arch, 6

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?
38620	Custom-made mouthguard	A custom-made oral device designed to protect the teeth, bones, and tissues of the mouth from damage due to impact/trauma typically during contact sports, and/or to prevent teeth grinding/clenching (bruxism). It is custom-made for a specified patient from impressions of the dental arch. Some types are referred to as nightguards or bite raising appliances. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBI	RESIN, DENTURE, RELINING, REPAIRING, REBASING
MQC	Mouthguard, prescription

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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: Keep away from sunlight.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 6 iNterra™ Nightguard Arches, Medium Arch

Device Record Status

Public Device Record Key: d0fa12ab-d59d-4bb2-abb6-36080e1a6559
Public Version Date: December 20, 2023
Public Version Number: 5
DI Record Publish Date: September 21, 2016