AccessGUDID - DEVICE: BRILLIANT COMPONEER (J00660023136)

GUDID

Device Identifier (DI) Information

Brand Name: BRILLIANT COMPONEER
Version or Model: 60023136
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 60023136
Company Name: Coltène/Whaledent AG

Primary DI Number: J00660023136
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 480017482 *Terms of Use

Device Description: BRILLIANT COMPONEER are polymerised, prefabricated, highly filled, submicron hybrid composite enamel shells for direct veneering. BRILLIANT COMPONEER upper jaw L bleach translucent 13.

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:	Yes
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?
38645	Dental veneer, professional	A custom-made dental restoration made of ceramic or polymer-based material (resin) intended to be used in aesthetic dentistry to correct the facial surface of a tooth; it is intended to be applied to the teeth by a dental professional for long-term use, typically via an adhesive. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBF	Material, Tooth Shade, Resin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K191385	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
Special Storage Condition, Specify: Do not expose to direct sunlight or other heat sources.
Special Storage Condition, Specify: Store at 4-23 °C / 39-73 °F

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e8467db6-45fd-483a-b9b6-05a48de599f5
Public Version Date: February 05, 2021
Public Version Number: 2
DI Record Publish Date: February 07, 2020