AccessGUDID - DEVICE: Ora-GUARD (00816161015131)

GUDID

Device Identifier (DI) Information

Brand Name: Ora-GUARD
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Doc Brands, Inc.

Primary DI Number: 00816161015131
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081254601 *Terms of Use

Device Description: Ora-GUARD is an OTC device worn on the teeth while sleeping, intended to protect the teeth and reduce damage caused by bruxing or nighttime grinding and prevention of the noise associated with bruxing and grinding.

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):	Yes
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?
46493	Removable dental occlusal splint, customizable	A device intended for home-use intended to overlay the occlusal surfaces of the teeth to maintain the position of displaced or moveable teeth, to treat teeth clenching and bruxism and their sequelae, and to provide temporary relief from muscle or temporomandibular joint (TMJ) pain (e.g., from TMJ dysfunction). It is removable by the patient (e.g., during meals), and is typically made of plastic materials and can be softened, typically in hot water, and moulded over the teeth by the user to provide an anatomical fit (customizable). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OBR	Mouthguard, Over-The-Counter

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6a947f81-c112-4301-ab0e-8d45f4f55db7
Public Version Date: February 10, 2025
Public Version Number: 3
DI Record Publish Date: March 09, 2022