AccessGUDID - DEVICE: Paradigm Quantum (D948PBXMDH251)

GUDID

Device Identifier (DI) Information

Brand Name: Paradigm Quantum
Version or Model: MDHT
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PBX-MD-H25
Company Name: Smarter Alloys Inc

Primary DI Number: D948PBXMDH251
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 6
Labeler D-U-N-S® Number*: 200106716 *Terms of Use

Device Description: .06v taper NiTi reciprocating endodontic file, size medium, 25mm length, heat treated

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):	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?
63550	Rotary/reciprocating endodontic file/rasp, single-use	A dental endpiece designed to be attached to a rotary or reciprocating dental power tool handpiece to debride and enlarge the root canal and smooth its walls by cutting or abrasion. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and its working end has a polygonal cross-section with edges. It may also be referred to as a rotary or engine file, or reamer. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EKS	File, Pulp Canal, Endodontic

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 [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 14f8cd12-9525-4f6f-a48a-35a6cde3bbb6
Public Version Date: September 02, 2021
Public Version Number: 1
DI Record Publish Date: August 25, 2021