FDA.report

Primeprint Guide

Primary DI
EDET027101
Brand
Primeprint Guide
Company
DETAX GmbH & Co. KG
Model
02710
Published
2022-01-12
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
DYTMaintainer, Space Preformed, Orthodontic
KMYPositioner, Tooth, Preformed

Product Code Classifications

CodeDeviceSpecialtyClass
DYTMaintainer, Space Preformed, OrthodonticDental1
KMYPositioner, Tooth, PreformedDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
EDET027101PrimaryHIBCC0

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
Moist Heat or Steam Sterilization

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
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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
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
00810126381576Band loop space regainerDigital Dental Laboratories, IncDYT2026-02-25
00810126381583Bihelix - solderedDigital Dental Laboratories, IncDYT2026-02-25
00810126381590Crozat crib and crescentDigital Dental Laboratories, IncDYT2026-02-25
00810126381606Marangos tripod splintDigital Dental Laboratories, IncDYT2026-02-25
00810126381613MonoblockDigital Dental Laboratories, IncDYT2026-02-25
00810126381620Orthopedic correctorDigital Dental Laboratories, IncDYT2026-02-25
00810126381637Orthotic - splintsDigital Dental Laboratories, IncDYT2026-02-25
00810126381644PositionerDigital Dental Laboratories, IncDYT2026-02-25
00810126381651Splint - "B"Digital Dental Laboratories, IncDYT2026-02-25
00810126381668Splint - 2 "C" ClaspsDigital Dental Laboratories, IncDYT2026-02-25
00810126381675Splint - 2 Adams ClaspsDigital Dental Laboratories, IncDYT2026-02-25
00810126381682Splint - 2 Ball ClaspsDigital Dental Laboratories, IncDYT2026-02-25
00810126381699Splint - 2 Ball Clasps/AcetalDigital Dental Laboratories, IncDYT2026-02-25
00810126381705Splint - 4 Ball ClaspsDigital Dental Laboratories, IncDYT2026-02-25
00810126381712Splint - Anterior DeprogrammerDigital Dental Laboratories, IncDYT2026-02-25
00810126381729Splint - BiocrylDigital Dental Laboratories, IncDYT2026-02-25
00810126381736Splint - BruxeezeDigital Dental Laboratories, IncDYT2026-02-25