neo.lign P tooth posterior TUWL3A20

GUDID EBRETUWL3A209

neo.lign P tooth posterior WL3 lower A20 8 parts (34,35,36,37/44,45,46,47) 1 Assortment

bredent GmbH & Co. KG

Custom-made dental crown, metal/ceramic Custom-made dental crown, metal/ceramic Custom-made dental crown, metal/ceramic Custom-made dental crown, metal/ceramic Custom-made dental crown, metal/ceramic Custom-made dental crown, metal/ceramic Custom-made dental crown, metal/ceramic Custom-made dental crown, metal/ceramic Custom-made dental crown, metal/ceramic Custom-made dental crown, metal/ceramic Custom-made dental crown, metal/ceramic Custom-made dental crown, metal/ceramic Custom-made dental crown, metal/ceramic
Primary Device IDEBRETUWL3A209
NIH Device Record Key471dbf6f-6f28-4c73-be74-3eea9b2dd331
Commercial Distribution StatusIn Commercial Distribution
Brand Nameneo.lign P tooth posterior
Version Model NumberTUWL3A20
Catalog NumberTUWL3A20
Company DUNS341086190
Company Namebredent GmbH & Co. KG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEBRETUWL3A200 [Primary]
HIBCCEBRETUWL3A209 [Package]
Contains: EBRETUWL3A200
Package: dummy [1 Units]
Discontinued: 2023-08-30
Not in Commercial Distribution

FDA Product Code

ELMDenture, plastic, teeth

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-07
Device Publish Date2023-08-30

On-Brand Devices [neo.lign P tooth posterior]

EBRETUWL3A209neo.lign P tooth posterior WL3 lower A20 8 parts (34,35,36,37/44,45,46,47) 1 Assortment
EBRETOWL4A209neo.lign P tooth posterior WL4 upper A20 8 parts (14,15,16,17/24,25,26,27) 1 Assortment
EBRETOWL3A209neo.lign P tooth posterior WL3 upper A20 8 parts (14,15,16,17/24,25,26,27) 1 Assortment

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.