AccessGUDID - DEVICE: BRILLIANT Crios (J00660019998)

GUDID

Device Identifier (DI) Information

Brand Name: BRILLIANT Crios
Version or Model: 60019998
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 60019998
Company Name: Coltène/Whaledent AG

Primary DI Number: J00660019998
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 480017482 *Terms of Use

Device Description: BRILLIANT Crios CEREC/inLab – 5 blocs, size 12, Low Translucent, Bleach BRILLIANT Crios is a reinforced composite bloc for the fabrication of permanent, aesthetic single-tooth restorations using a CAD/CAM milling process. BRILLIANT Crios is available in a variety of shades and sizes. Composition: Dental glass, cross-linked methacrylates, amorphous silica.

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?
38649	Resin dental inlay	A custom-made dental restoration made of resin-based material that is bonded within the center of a tooth (intracoronal) typically to serve as a well-fitting, long-lasting alternative to dental fillings for tooth decay or similar damage. It is fabricated indirectly in a dental lab, sometimes by computer-aided design/computer-aided manufacturing (CAD/CAM) techniques, before being fitted and bonded to the damaged tooth. 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 [?]
K181500	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: Storage: 4-23 °C / 39-73°F

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7a04c691-ea41-4246-988c-1c96c28745c1
Public Version Date: November 01, 2018
Public Version Number: 1
DI Record Publish Date: October 01, 2018