bulk box mix.cann.optima lila 2500pcs

GUDID EDET032451

DETAX GmbH

Dental impression material syringe, reusable
Primary Device IDEDET032451
NIH Device Record Keyef7ae647-9441-4329-9cda-b19bc6e342f2
Commercial Distribution StatusIn Commercial Distribution
Brand Namebulk box mix.cann.optima lila 2500pcs
Version Model Number03245
Company DUNS343947949
Company NameDETAX GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEDET032451 [Primary]

FDA Product Code

KCPSyringe, Ent

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-29
Device Publish Date2023-12-21

Devices Manufactured by DETAX GmbH

EDET047181 - RS VIVO Denture Flex transparent 1000g2025-11-28
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

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.