AccessGUDID - DEVICE: Radica® (D0019083600)

GUDID

Device Identifier (DI) Information

Brand Name: Radica®
Version or Model: Material Assortment Kit
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 908360
Company Name: Dentsply International Inc.

Primary DI Number: D0019083600
Issuing Agency: HIBCC
Commercial Distribution End Date: May 05, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 606173334 *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):	No
Over the Counter (OTC):	No
Kit:	Yes
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?
31783	Temporary dental crown/bridge	A prosthetic dental device intended to temporarily replace the top of a tooth or a group of teeth until a permanent restoration is fabricated. The device is typically made of plastic material [e.g., polymethylmethacrylate (PMMA)].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBG	CROWN AND BRIDGE, TEMPORARY, RESIN
EBD	COATING, FILLING MATERIAL, RESIN

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
Device Size Text, specify: Contains: Radica Sealer (908110), Radica Stains (908112-908115), and Radica Effect Dentin Tissue Tint (908119)

Device Record Status

Public Device Record Key: 1faa12bb-b039-493f-b55d-1633a89ecb38
Public Version Date: May 06, 2022
Public Version Number: 4
DI Record Publish Date: September 21, 2016