FDA.reportPublic FDA data

Freeprint ortho UV 1000g

Primary DI
EDET040951
Brand
Freeprint ortho UV 1000g
Company
DETAX GmbH
Model
04095
Published
2022-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DYJRetainer, Screw Expansion, Orthodontic
DYTMaintainer, Space Preformed, Orthodontic
KMYPositioner, Tooth, Preformed
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYJRetainer, Screw Expansion, OrthodonticDental1
DYTMaintainer, Space Preformed, OrthodonticDental1
KMYPositioner, Tooth, PreformedDental1
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EDET040951PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental occlusal splint, custom-madeA rigid or flexible custom-made appliance that overlays the occlusal surfaces of the teeth. It is used 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). This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
343947949
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EDET035381luxaprint 3D shell UV beige 500 g035382022-10-25
EDET037171luxaprint 3D mould UV clear 500g037172022-10-25
EDET037181luxaprint 3D mould UV rose 500g037182022-10-25
EDET037471freeprint shell beige 1000 g037472022-10-25
EDET039191freeprint shell black 1000 g039192022-10-25
EDET039461luxaprint 3D mould UV rose orange 1000 g039462022-10-25
EDET039731luxaprint 3D mould UV light beige 1000 g039732022-10-25
EDET040731medicalprint shell, white, 1000 g040732022-10-25
EDET038421luxaprint 3D shell white 500g038422024-08-28
EDET042461luxaprint flex UV 500 g042462022-10-26
EDET047491FREEPRINT crown A3,5 500g047492026-04-13
EDET047511FREEPRINT crown A3,5 1000g047512026-04-13
EDET047081FREEPRINT crown A3,5 1000g047082026-02-04
EDET047091FREEPRINT crown A3,5 500g047092026-02-04
EDET047541dx retainer 5 kg047542026-03-06
EDET047551dx retainer 1000g047552026-03-06
EDET030161medicalprint shell beige 2.0 1000g030162026-02-25
EDET042611Ultraprint-Dental Gingiva UV 1000g042612022-10-14
EDET045881VITA VIONIC® DENT RESIN A3,5 500 g045882026-02-04
EDET045891VITA VIONIC® DENT RESIN A3,5 1000 g045892026-02-04

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Primary DI, Brand, Company table
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07899878068266NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068273NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068280NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068297NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
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