FDA.reportPublic FDA data

Reva Thermoforming Sheet Material

Primary DI
00860461001790
Brand
Reva Thermoforming Sheet Material
Company
Ulab Systems, Inc.
Model
FG0010
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.
Published
2025-04-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
MQCMouthguard, Prescription

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQCMouthguard, PrescriptionUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860461001790PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860461001790008604610017908604610017900860461001790

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic progressive alignerA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081092722
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860461001714Clearjoy Dental Aligner1FG0094-052023-11-02
00860461001776uLab Systems uDesign10FG00642025-01-28
00860461001783uLab Systems uDesign9FG00642024-05-20
00860002380094uLab Systems Dental AlignerFG0094 2022-06-01
00860461001769uLab Systems uDesign8FG00642023-11-02
00860002380087uLab Systems uDesign72022-04-11
00860002380049uLab Systems uDesign5.9FG00642020-11-16
00860002380070uLab Systems uDesign6.02021-05-10
00860002380063uLab Systems Dental AlignerFG0094 Rev. D2020-10-12
00860002380032uLab Systems uDesignVersion 5.8FG00642020-07-14
00860002380056uLab Systems Dental AlignerFG00942020-07-20
00860002380025uLab Systems uDesignVersion 5.6FG00642020-07-10
00860002380001uLab Systems uDesignVersion 5FG00642019-09-18
00860002380018uLab Systems uDesignVersion 5.5FG00642020-02-18
00860461001707uLab Systems uDesignVersion 2.2FG00642018-08-20
00000860002381uLab Systems uDesignVersion 5.5FG00642020-02-18
00008600023801uLab Systems uDesignVersion 5FG00642019-09-18

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EPRCD1001501printodent GR-19.1 OApro3dure medical GmbHMQC2023-08-29
EPRCD1001504printodent GR-19.1 OA I MSIpro3dure medical GmbHMQC2023-08-29
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