FDA.report

Freeprint ortho 405 1000g

Primary DI
EDET040891
Brand
Freeprint ortho 405 1000g
Company
DETAX GmbH & Co. KG
Model
04089
Published
2022-10-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
DYJRetainer, Screw Expansion, Orthodontic
KMYPositioner, Tooth, Preformed

Product Code Classifications

CodeDeviceSpecialtyClass
DYJRetainer, Screw Expansion, OrthodonticDental1
KMYPositioner, Tooth, PreformedDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
EDET040891PrimaryHIBCC0

GMDN Terms

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

Regulatory Flags

DUNS number
317099257
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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EDET021651detax Impression lacquer 1000 ml021652022-10-26
EDET025891detax Impression lacquer 30 ml025892022-10-26
EDET041641medicalprint shell blue opaque 1000g041642022-10-26
EDET041651medicalprint shell red opaque 1000g041652022-10-26
EDET042301detax softwear 2.0 clear 40 shore 8x 50 ml042302022-10-26
EDET042381detax softwear 2.0 blue 60 shore 2 x 50 ml042382022-10-26
EDET042461luxaprint flex UV 500 g 042462022-10-26
EDET027231aquaplus putty blue 2 x 250 ml027232022-10-25
EDET027241aquaplus putty red 2 x 250 ml027242022-10-25
EDET029411protect mold neon pink 2 x 100ml029412022-10-25
EDET029461protect mold neon green 2 x 100ml029462022-10-25
EDET029471protect mold neon green 2 x 100ml029472022-10-25
EDET029481protect mold neon orange 2 x 100ml029482022-10-25
EDET029491super coat 100ml029492022-10-25
EDET029501super coat 300ml029502022-10-25
EDET029911earflex 40 sh rainbow 8 x 50 ml029912022-10-25
EDET030121express coat 100ml030122022-10-25
EDET030141dip coat 100ml030142022-10-25
EDET030151dip coat 250ml030152022-10-25
EDET031921earflex 40 sh clear 8 x 50 ml031922022-10-25

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00190746067549PowerScopeAMERICAN ORTHODONTICS CORPORATIONDYJ2026-03-24
00190746067563PowerScopeAMERICAN ORTHODONTICS CORPORATIONDYJ2026-03-24
00190746067587PowerScopeAMERICAN ORTHODONTICS CORPORATIONDYJ2026-03-24
00190746153273PowerScopeAMERICAN ORTHODONTICS CORPORATIONDYJ2026-03-24
00190746202742PowerScopeAMERICAN ORTHODONTICS CORPORATIONDYJ2026-03-24
00190746202759PowerScopeAMERICAN ORTHODONTICS CORPORATIONDYJ2026-03-24
00815967029380RodinPac-Dent, Inc.KMY2026-03-23
00815967029397RodinPac-Dent, Inc.KMY2026-03-23
06974361422556Zhejiang YinchiliZhejiang Yinchili Medical Technology Co., Ltd.KMY2026-03-23
06974361422563Zhejiang YinchiliZhejiang Yinchili Medical Technology Co., Ltd.KMY2026-03-23
06974361422570Zhejiang YinchiliZhejiang Yinchili Medical Technology Co., Ltd.KMY2026-03-23
06974361422587Zhejiang YinchiliZhejiang Yinchili Medical Technology Co., Ltd.KMY2026-03-23
06974361423058Zhejiang YinchiliZhejiang Yinchili Medical Technology Co., Ltd.KMY2026-03-23
06974361423065Zhejiang YinchiliZhejiang Yinchili Medical Technology Co., Ltd.KMY2026-03-23
06974361423072Zhejiang YinchiliZhejiang Yinchili Medical Technology Co., Ltd.KMY2026-03-23
06974361423089Zhejiang YinchiliZhejiang Yinchili Medical Technology Co., Ltd.KMY2026-03-23
03770020010163FroggymouthBIOTECH DENTAL SMILERSKMY2026-03-17
03770020010170FroggymouthBIOTECH DENTAL SMILERSKMY2026-03-17
03770020010187FroggymouthBIOTECH DENTAL SMILERSKMY2026-03-17
EDET047541dx retainer 5 kgDETAX GmbHDYJ2026-03-06
EDET047551dx retainer 1000gDETAX GmbHDYJ2026-03-06
00810126381330Bihelix - RemovableDigital Dental Laboratories, IncDYJ2026-02-25
00810126381347Daytime applianceDigital Dental Laboratories, IncDYJ2026-02-25
00810126381354Inman spring alignerDigital Dental Laboratories, IncDYJ2026-02-25
00810126381408Retainer - 3 to 3 with meshDigital Dental Laboratories, IncDYJ2026-02-25
00810126381415Retainer - 6 mesh padsDigital Dental Laboratories, IncDYJ2026-02-25
00810126381446Retainer - lower clipDigital Dental Laboratories, IncDYJ2026-02-25
00810126381460Retainer - unsolderedDigital Dental Laboratories, IncDYJ2026-02-25
00810126381477Retainer - wrapDigital Dental Laboratories, IncDYJ2026-02-25
00810126381484Retainer- Soldered 2 arrow head claspsDigital Dental Laboratories, IncDYJ2026-02-25