AccessGUDID - DEVICE: PORTUX CAD/CAM Disc. 98.5X 18mm A3.5. MN (07701126712237)

GUDID

Device Identifier (DI) Information

Brand Name: PORTUX CAD/CAM Disc. 98.5X 18mm A3.5. MN
Version or Model: 0022230
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0022230
Company Name: PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A

Primary DI Number: 07701126712237
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 880141023 *Terms of Use

Device Description: PORTUX CAD/CAM Disc. 98.5X 18mm A3.5. MN

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:	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 [?]
K192153	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: b1683d3e-56af-45f7-a695-860052d1ff16
Public Version Date: March 15, 2024
Public Version Number: 1
DI Record Publish Date: March 07, 2024