AccessGUDID - DEVICE: neo.lign P tooth posterior (EBRETOWL4A200)

GUDID

Device Identifier (DI) Information

Brand Name: neo.lign P tooth posterior
Version or Model: TOWL4A20
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TOWL4A20
Company Name: bredent GmbH & Co. KG

Primary DI Number: EBRETOWL4A200
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 341086190 *Terms of Use

Device Description: neo.lign P tooth posterior WL4 upper A20 8 parts (14,15,16,17/24,25,26,27) 1 Assortment

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
38593	Custom-made dental crown, metal/ceramic	A device made of a combination of metal and tooth-coloured ceramic, and created for a specific post-pubescent/adult patient (custom-made), that functions as an artificial covering to replace the major part, or the whole part, of the clinical crown of a tooth.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ELM	Denture, plastic, teeth

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 03174ab8-9f73-49b0-b87e-f5b221b8ba5f
Public Version Date: September 07, 2023
Public Version Number: 1
DI Record Publish Date: August 30, 2023