AccessGUDID - DEVICE: Radix-Anker® Standard Set (J003C195DT00000001)

GUDID

Device Identifier (DI) Information

Brand Name: Radix-Anker® Standard Set
Version or Model: C195DT0000000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: C195DT0000000
Company Name: MAILLEFER INSTRUMENTS HOLDING Sàrl

Primary DI Number: J003C195DT00000001
Issuing Agency: HIBCC
Commercial Distribution End Date: June 30, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 480538495 *Terms of Use

Device Description: Endodontic Posts Set - Dr Spang

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):	No
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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: N/A

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0fdbef63-0578-46ff-ae63-12f73a7ecde7
Public Version Date: June 06, 2025
Public Version Number: 2
DI Record Publish Date: September 30, 2022