AccessGUDID - DEVICE: YC3 Shield (00190746075889)

GUDID

Device Identifier (DI) Information

Brand Name: YC3 Shield
Version or Model: 855-711M
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 855-711M
Company Name: AMERICAN ORTHODONTICS CORPORATION

Primary DI Number: 00190746075889
Issuing Agency: GS1
Commercial Distribution End Date: February 17, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 044668515 *Terms of Use

Device Description: YC3 CLASS III MIXED DENTITION APPLIANCE MIXED DENTITION

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?
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
BRW	Protector, dental

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0a734b6c-dcec-483b-b61f-3329635dbe32
Public Version Date: October 21, 2024
Public Version Number: 5
DI Record Publish Date: September 04, 2020