AccessGUDID - DEVICE: Advance Dental Products (10850455007232)

GUDID

Device Identifier (DI) Information

Brand Name: Advance Dental Products
Version or Model: 1000123
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: The Atlanta Dental Supply Company

Primary DI Number: 10850455007232
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 033505389 *Terms of Use

Device Description: Advance Temporary Crown & Bridge Material A3 Cartridge + Tips

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):	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?
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
EBF	Material, tooth shade, resin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K130672	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: 7726bc5d-8c61-4245-8557-e058b3a00c78
Public Version Date: March 14, 2023
Public Version Number: 1
DI Record Publish Date: March 06, 2023