AccessGUDID - DEVICE: Patterson® (D6620703523022)

GUDID

Device Identifier (DI) Information

Brand Name: Patterson®
Version or Model: 70352302
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 70352302
Company Name: PATTERSON DENTAL SUPPLY, INC.

Primary DI Number: D6620703523022
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 171843584 *Terms of Use

Device Description: RESIN, ROOT CANAL FILLING

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?
65738	Endodontic obturation material distribution endpiece, reusable	A dental endpiece designed to be attached to a dental power tool handpiece to distribute root canal sealer/cement/paste evenly throughout the root canal system typically by applying the material in a lateral direction. It is a thin metal rod with a spiral (e.g., Lentulo spiral type), helicoidal, or circular design. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MTA	Lens, intraocular, phakic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K130125	000

Device Exempt from Premarket Submission: No 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b197c264-424a-413a-a292-f1a0f6da408f
Public Version Date: December 20, 2024
Public Version Number: 3
DI Record Publish Date: September 23, 2016