AccessGUDID - DEVICE: E-Guard Blue (04260683220041)

GUDID

Device Identifier (DI) Information

Brand Name: E-Guard Blue
Version or Model: RES-01-3121
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RES-01-3121
Company Name: Envisiontec GmbH

Primary DI Number: 04260683220041
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 332025159 *Terms of Use

Device Description: E-Guard Blue is a light-curing material for the additive manufacturing of individual dental bite splints

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?
43025	Removable dental occlusal splint, custom-made	A rigid or flexible custom-made device 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 synthetic polymer materials and manufactured to meet the needs of an individual patient. This is a reusable device.	Active	false
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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K201173	000

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: Protect from sunlight
Storage Environment Temperature: between 41 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fc74e2eb-c916-4f19-b4b8-1a4687c28e67
Public Version Date: October 21, 2024
Public Version Number: 2
DI Record Publish Date: December 17, 2020