AccessGUDID - DEVICE: DD tempMED (EDDIK111151)

GUDID

Device Identifier (DI) Information

Brand Name: DD tempMED
Version or Model: 98H15 A3
Commercial Distribution Status: In Commercial Distribution
Catalog Number: K11115
Company Name: Dental Direkt GmbH

Primary DI Number: EDDIK111151
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 313214171 *Terms of Use

Device Description: DD tempMED are pre-colored dental milling blanks out of PMMA for the manufacture of temporary crowns and bridges for long-term application in the oral cavity up to 12 months.

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):	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?
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 [?]
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
Outer Diameter: 98.5 Millimeter
Height: 15 Millimeter

Device Record Status

Public Device Record Key: bcc9580f-c8f9-452a-b886-3c5e536f2830
Public Version Date: October 29, 2021
Public Version Number: 3
DI Record Publish Date: October 05, 2016