AccessGUDID - DEVICE: MIMIC-3D Dental (00817169020165)

GUDID

Device Identifier (DI) Information

Brand Name: MIMIC-3D Dental
Version or Model: TCB-A3
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: 3D DENTAL DESIGNS AND DEVELOPMENT, LLC

Primary DI Number: 00817169020165
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080194935 *Terms of Use

Device Description: TEMPORARY CROWN & BRIDGE MATERIAL 76GM 10:1 5 TIPS A3

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):	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?
45236	Temporary dental crown/bridge resin	A material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated.	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 [?]
K102753	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 08d6bea5-878f-4038-b719-6f2743cfe795
Public Version Date: October 29, 2021
Public Version Number: 4
DI Record Publish Date: January 18, 2017