visio.paint Stains 54001250

GUDID EBRE540012509

visio.paint Stains assortment 14 parts 1 Assortment

bredent GmbH & Co. KG

Dental prosthesis veneer resin
Primary Device IDEBRE540012509
NIH Device Record Key34df831c-690c-40e3-bd80-9b855207be6c
Commercial Distribution StatusIn Commercial Distribution
Brand Namevisio.paint Stains
Version Model Number54001250
Catalog Number54001250
Company DUNS341086190
Company Namebredent GmbH & Co. KG
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEBRE540012500 [Primary]
HIBCCEBRE540012509 [Package]
Contains: EBRE540012500
Package: dummy [1 Units]
Discontinued: 2023-09-01
Not in Commercial Distribution

FDA Product Code

EBFMaterial, tooth shade, resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-11
Device Publish Date2023-09-01

Devices Manufactured by bredent GmbH & Co. KG

EBREVLCOLBLACK9 - visio.lign color Black2025-03-18 visio.lign color Black 2.6 ml
EBREVLCOLBLUE9 - visio.lign color Blue2025-03-18 visio.lign color Blue 2.6 ml
EBREVLCOLBODYA9 - visio.lign color Body A2025-03-18 visio.lign color Body A 2.6 ml
EBREVLCOLBODYB9 - visio.lign color Body B2025-03-18 visio.lign color Body B 2.6 ml
EBREVLCOLBODYC9 - visio.lign color Body C2025-03-18 visio.lign color Body C 2.6 ml
EBREVLCOLBODYD9 - visio.lign color Body D2025-03-18 visio.lign color Body D 2.6 ml
EBREVLCOLBROWN9 - visio.lign color Brown2025-03-18 visio.lign color Brown 2.6 ml
EBREVLCOLCREME9 - visio.lign color Creme2025-03-18 visio.lign color Creme 2.6 ml

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