Primeprint Splint SF 1000g

GUDID EDET044161

DETAX GmbH

Dental occlusal splint, custom-made
Primary Device IDEDET044161
NIH Device Record Keyc726dd08-1515-44e2-8664-9e5bde3bd629
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrimeprint Splint SF 1000g
Version Model Number04416
Company DUNS343947949
Company NameDETAX GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEDET044161 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DYJRetainer, Screw Expansion, Orthodontic
KMYPositioner, Tooth, Preformed

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-02
Device Publish Date2023-10-25

Devices Manufactured by DETAX GmbH

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EDET047191 - RS VIVO Denture Flex pink transparent 1000g2025-11-28
EDET047201 - RS VIVO Denture Impact pink 1000g2025-11-28
EDET047211 - RS VIVO Denture Impact pink transparent 1000g2025-11-28
EDET047221 - RS VIVO IBT 1000g2025-11-28
EDET047231 - RS VIVO Splint Flex 1000g2025-11-28
EDET047241 - RS VIVO Splint Hard 1000g2025-11-28
EDET047011 - Freeprint denture flex pink-transparent 1.000g2025-11-26

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