AccessGUDID - DEVICE: EndoPilot Obtura set (04260482991128)

GUDID

Device Identifier (DI) Information

Brand Name: EndoPilot Obtura set
Version or Model: v01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 110 0133-US
Company Name: Schlumbohm GmbH & Co. KG

Primary DI Number: 04260482991128
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 343831731 *Terms of Use

Device Description: EndoPilot Obtura expansion set consist of: 1x BackFill Gun Obtura, 1x Obtura Needle Lock Nut, 4x Heat Insulator, 5x Gun-Needle Ø 25 ga, 100x Gutta Percha Bar, Accessory tools

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?
45247	Endodontic obturation system	An assembly of devices intended to be used during endodontic treatment involving root canal obturation procedures. It may be used in a variety of modes, e.g., to provide continuous heat to the tip of a dental instrument to test tooth response to thermal stimulus, for tissue cauterization and coagulation, and to backfill and down pack gutta-percha during endodontic root canal treatment or root canal obturation. It typically consists of a mains electricity (AC-powered) generator that regulates an electrical current used to produce resistive heat via the handpieces for the application of the heat, or extrude gutta-percha during a root canal obturation.	Active	false
45081	Synthetic gutta-percha	A dental material made from a polymer-based, synthetic gutta-percha containing fillers and radiopacifiers in a soft resin matrix, intended to fill the root canal of a tooth. This material has the ability to resist leakage significantly better than natural gutta-percha based obturation whilst strengthening the root resulting in roots having a coronal and apical seal as part of the canal filling process. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EKR	Plugger, Root Canal, Endodontic
EKM	Gutta-Percha

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization
High-level Disinfectant

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: 2717147a-6182-4bbc-995d-870c39956645
Public Version Date: October 22, 2021
Public Version Number: 1
DI Record Publish Date: October 14, 2021