AccessGUDID - DEVICE: MDC Dental (07506338300889)

GUDID

Device Identifier (DI) Information

Brand Name: MDC Dental
Version or Model: Bisacryl Nictone B2 Tone
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MDC DENTAL

Primary DI Number: 07506338300889
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 811180298 *Terms of Use

Device Description: Tone B2 Box wit: 2 10:1 cartridge with 70g (50 ml) + 20 mixing tips + instructions. It is used in the elaboration of all kinds of temporary dental Provisionals: inlays, onlays, veneers, bridges and partial or total crowns. It can be used as a filling / relining material for precast and temporary composite and metal crowns.

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):	No
Over the Counter (OTC):	Yes
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?
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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K991577	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
Storage Environment Temperature: between 23 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 39e887c0-7c9f-44fb-a1f4-1c8554e2f513
Public Version Date: November 10, 2021
Public Version Number: 1
DI Record Publish Date: November 02, 2021