Reva Thermoforming Sheet Material

GUDID 00860461001790

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.

Ulab Systems, Inc.

Orthodontic progressive aligner

• Primary Device ID: 00860461001790
• NIH Device Record Key: b97fb5a8-119d-4fba-931c-99a63508048f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reva Thermoforming Sheet Material
• Version Model Number: FG0010
• Company DUNS: 081092722
• Company Name: Ulab Systems, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860461001790 [Primary]

FDA Product Code

• MQC: Mouthguard, Prescription

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-07
• Device Publish Date: 2025-04-29

Devices Manufactured by Ulab Systems, Inc.

• 00860461001790 - Reva Thermoforming Sheet Material: 2025-05-07The 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.
• 00860461001790 - Reva Thermoforming Sheet Material: 2025-05-07 The uLab Systems Reva Disc is a non-sterile sheet of thermoplastic intended to be used by a dental practitioner to fabricate pol
• 00860461001776 - uLab Systems uDesign: 2025-02-05 The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imp
• 00860461001783 - uLab Systems uDesign: 2024-05-28 The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imp
• 00860461001714 - Clearjoy Dental Aligner: 2023-11-10 The Clearjoy Dental Aligner kit is a line extension of the uLab Systems Dental Aligner Kit and is an orthodontic treatment syste
• 00860461001769 - uLab Systems uDesign: 2023-11-10 The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imp
• 00860002380087 - uLab Systems uDesign: 2023-04-04 The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imp
• 00860002380094 - uLab Systems Dental Aligner: 2022-06-09 The uLab Systems Dental Aligner Kit is an orthodontic treatment system, that consists of doctor-prescribed, clear, thin, plastic
• 00860002380049 - uLab Systems uDesign: 2021-07-27 The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imp