AccessGUDID - DEVICE: Reva Thermoforming Sheet Material (00860461001790)

GUDID

Device Identifier (DI) Information

Brand Name: Reva Thermoforming Sheet Material
Version or Model: FG0010
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Ulab Systems, Inc.

Primary DI Number: 00860461001790
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081092722 *Terms of Use

Device Description: The uLab Systems Reva Disc is a non-sterile sheet of thermoplastic intended to be used by a dental practitioner to fabricate polymer orthodontic and dental appliances. The sheets of material are heated by the dental practitioner in an office setting and then vacuum-formed over a dental impression of the patient’s teeth. Once formed, the appliance is then trimmed to fit the patient.

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):	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?
44738	Orthodontic progressive aligner	A custom-made orthodontic appliance, typically supplied in series intended to be worn in succession and self-changed every few weeks, designed to influence the shape and/or function of the stomatognathic system to correct malocclusions (e.g., underbites, overbites, cross bites, open bites, crooked teeth) and/or other cosmetic and/or structural flaws of teeth and/or jaws. Also described as sequential or successive, the device is custom-made based on an oral impression, self-removable, and is typically made of clear/transparent synthetic polymers (e.g., a thermoformed polycarbonate); a post-treatment orthodontic retainer/positioner may be included with the device. 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 [?]
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: b97fb5a8-119d-4fba-931c-99a63508048f
Public Version Date: May 07, 2025
Public Version Number: 1
DI Record Publish Date: April 29, 2025