AccessGUDID - DEVICE: VarseoSmile TriniQ (EBGOBGTQA2011)

GUDID

Device Identifier (DI) Information

Brand Name: VarseoSmile TriniQ
Version or Model: BGTQA201
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BGTQA201
Company Name: BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co.KG

Primary DI Number: EBGOBGTQA2011
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 316483072 *Terms of Use

Device Description: No description.

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?
38595	Custom-made dental crown, polymer	A device made entirely of polymer-based material with or without fibre reinforcement, 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
PZY	Additively Manufactured, Preformed, Resin Denture Tooth
EBF	Material, Tooth Shade, Resin
EBG	Crown And Bridge, Temporary, Resin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K233596	000

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
Handling Environment Temperature: between 18 and 35 Degrees Celsius
Storage Environment Temperature: between 4 and 35 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9641b8e1-7712-4b42-a2af-aa732eee7f05
Public Version Date: September 12, 2024
Public Version Number: 1
DI Record Publish Date: September 04, 2024