AccessGUDID - DEVICE: iNterra™ iNoffice Nightguard Starter Kit (D00261D0101)

GUDID

Device Identifier (DI) Information

Brand Name: iNterra™ iNoffice Nightguard Starter Kit
Version or Model: 61D010
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 61D010
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D00261D0101
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: iNterra™ iNoffice Nightguard Starter Kit

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:	Yes
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
MQC	Mouthguard, prescription
EBI	RESIN, DENTURE, RELINING, REPAIRING, REBASING

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.
Storage Environment Temperature: between 10 and 24 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 50 Milliliter
Device Size Text, specify: 1 Small Arch, 2 Medium Arches, 1 Large Arch, 1 Cartridge Regisil® Rigid Super Fast Set Material (50mL), 6 Mixing Tips

Device Record Status

Public Device Record Key: 04f8b2fe-7b78-44c8-8f0f-0e64cec1c129
Public Version Date: September 24, 2018
Public Version Number: 4
DI Record Publish Date: September 21, 2016