AccessGUDID - DEVICE: LuxaPost (EDMG1107830)

GUDID

Device Identifier (DI) Information

Brand Name: LuxaPost
Version or Model: 110783
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 110783
Company Name: DMG Chemisch-Pharmazeutische Fabrik GmbH

Primary DI Number: EDMG1107830
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 320744915 *Terms of Use

Device Description: Glass fiber-reinforced pre-silanized composite root post. The DMG quality root post. Content: 5 posts (pre-silanized, Ø 1.5 mm ).

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?
38609	Root canal post, preformed	A prefabricated endodontic rod designed for insertion into the root canal of a patient to support and retain a crown prosthesis. It is typically a solid, cylindrical, metal (e.g., stainless steel, gold alloy) piece with a proximal end appropriate to support the crown on top; it is, however, available in a variety of shapes, dimensions, and materials (e.g., ceramics, fibre-reinforced polymers). In addition, it is available in a variety of types (e.g., non-threaded, pre-threaded, or self-tapping; straight or tapered). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ELR	Post, Root Canal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Liquid Chemical

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 25 Degrees Celsius
Storage Environment Temperature: between 36 and 77 Degrees Fahrenheit
Special Storage Condition, Specify: Protect against chemical vapors.

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 1.5 Millimeter

Device Record Status

Public Device Record Key: c4d78795-830c-42c4-a537-b419a183ed75
Public Version Date: September 09, 2022
Public Version Number: 1
DI Record Publish Date: September 01, 2022