AccessGUDID - DEVICE: LuxaPost (EDMG1107801)

GUDID

Device Identifier (DI) Information

Brand Name: LuxaPost
Version or Model: 110780
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 110780
Company Name: DMG Chemisch-Pharmazeutische Fabrik GmbH

Primary DI Number: EDMG1107801
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 320744915 *Terms of Use

Device Description: Core-build-up and post cementation. Content: 5 posts Ø 1.25 mm, 5 posts Ø 1.375 mm, 5 posts Ø 1.5 mm, 1 drill Ø 1.25 mm, 1 drill Ø 1.375 mm, 1 drill Ø 1.5 mm, 30 silicone stops.

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?
45650	Root canal post kit	A collection of dental devices intended for use during insertion of a root canal post(s), sometimes with core build-up. This device typically includes a prefabricated root canal post(s), drill(s), thread cutter, and may include core-build-up materials such as applicator (dispensing gun), dental composite resin(s), dentine bonding agent, and etching solution. This is a reusable 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: 1.25 Millimeter
Outer Diameter: 1.375 Millimeter
Outer Diameter: 1.5 Millimeter

Device Record Status

Public Device Record Key: 1f350ccc-d212-4547-8a1c-e75964d56f36
Public Version Date: September 09, 2022
Public Version Number: 1
DI Record Publish Date: September 01, 2022