AccessGUDID - DEVICE: Luxatemp® Ultra (EDMG1109040)

GUDID

Device Identifier (DI) Information

Brand Name: Luxatemp® Ultra
Version or Model: 110904
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 110904
Company Name: DMG Chemisch-Pharmazeutische Fabrik GmbH

Primary DI Number: EDMG1109040
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 320744915 *Terms of Use

Device Description: Temporary crown and bridge material automix system; bis acrylic composite. For a look that is hard to beat. Content: 1 syringe @ 15 g paste, accessories. Color: B1.

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?
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 [?]
K101710	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
Special Storage Condition, Specify: Do not store in the refrigerator! Protect against exposure to direct sunlight!
Storage Environment Temperature: between 15 and 25 Degrees Celsius
Storage Environment Temperature: between 59 and 77 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fd0caee6-1e93-4964-8bd0-1e99bd21495c
Public Version Date: October 29, 2021
Public Version Number: 4
DI Record Publish Date: September 21, 2016