AccessGUDID - DEVICE: Capsule Extruder 2 (D010606065961)

GUDID

Device Identifier (DI) Information

Brand Name: Capsule Extruder 2
Version or Model: 60606596
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 60606596
Company Name: Dentsply De Trey GmbH

Primary DI Number: D010606065961
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315471722 *Terms of Use

Device Description: Capsule Extruder 2 is the device designed for extrusion and direct application of ChemFil® Rock restorative capsules

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?
16196	Dental material cartridge-plunging applicator, single-component	A hand-held manual device intended to dispense a single-component dental material (not included) from a cartridge directly into the mouth; it is not intended to dispense more than one component simultaneously. It is typically a pistol-like device with a cartridge-plunging mechanism. This is a reusable device after appropriate cleaning.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KXR	APPLICATOR, RESIN

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
Storage Environment Temperature: between 10 and 24 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 17.5 Centimeter

Device Record Status

Public Device Record Key: 26f8325f-cd75-4a8a-96cb-fe2413accab8
Public Version Date: January 08, 2021
Public Version Number: 2
DI Record Publish Date: December 16, 2020