FDA.reportPublic FDA data

Freeprint ortho 405 1000g

Primary DI
EDET040891
Brand
Freeprint ortho 405 1000g
Company
DETAX GmbH
Model
04089
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
EDET040891PrimaryHIBCC0

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
EDET027241aquaplus putty red 2 x 250 ml027242022-10-25
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07899995226457SLEEVE FOR SURGICAL GUIDEØ5.1MM OPENSin Sistema de Implante Nacional S/ANDP2026-10-29
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07899995226495SLEEVE FOR SURGICAL GUIDE Ø5.1MMSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995226501SLEEVE FOR SURGICAL GUIDE Ø5.1MMSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995226518SLEEVE FOR SURGICAL GUIDE Ø3.9MMSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995226525SLEEVE FOR SURGICAL GUIDE Ø3.9MMSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995226532SLEEVE FOR FIXER GUIDE Ø2.0MM PALATALSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995226556SLEEVE FOR FIXER GUIDE Ø2.0MM PALATALSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995226563SLEEVE FOR FIXER GUIDE Ø1.4MMSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234346DRIVER RATCHET IMP. MT16° GUIDEDSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234353DRIVER RATCHET IMP. MT16° GUIDED NARROWSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234360DRIVER HANDP. IMP. MT16° GUIDEDSin Sistema de Implante Nacional S/ANDP2026-10-29
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07899995234391ANALOG REVERSE MICRO MINI ABUT.Sin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234407ANALOG REVERSE MINI ABUT.Sin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234414ANALOG REVERSE CM11.5°Sin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234421ANALOG REVERSE MT16°Sin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234438ANALOG REVERSE ABUT MULT.Sin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234445ANALOG HYBRIDO ABUT UNIV Ø4.5X6MMSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234452ANALOG HYBRIDO ABUT UNIV Ø4.5X4MMSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234469ANALOG HYBRIDO ABUT UNIV Ø3.3X6MMSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234476ANALOG HYBRIDO ABUT UNIV Ø3.3X4MMSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234490ANALOG HYBRID MICRO MINI ABUT.Sin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234506ANALOG HYBRID 4.5IHSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234513ANALOG HYBRID 3.5IHSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234520ANALOG HYBRID 3.0IHSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234537ANALOG HYBRID HI Ø4.5MMSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234544ANALOG HYBRID HI Ø3.8MMSin Sistema de Implante Nacional S/ANDP2026-10-29