AccessGUDID - DEVICE: LYNX LONG BLUE NOSECONE (D826LX11SNCL03)

GUDID

Device Identifier (DI) Information

Brand Name: LYNX LONG BLUE NOSECONE
Version or Model: LX11SNCL
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MTI Precision Products, LLC

Primary DI Number: D826LX11SNCL03
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081600128 *Terms of Use

Device Description: LYNX LONG BLUE NOSECONE IS A STRAIGHT LOWSPEED DENTAL HANDPIECE ATTACHMENT THAT HOLDS BURS, DISCS AND MANDRELS WHICH WORKS TOGETHER WITH AN E-TYPE MOTOR AS A 1:1 TRANSMISSION FROM THE MOTOR TO THE BIT. IT IS USED FOR THE POLISHING OF TEETH AND REMOVAL OF CARRIES IN A DENTAL SETTING. THIS NOSECONE IS COMPATIBLE WITH ALL E-TYPE MOTORS

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?
66247	Dental power tool handpiece motorless component	A component of a dental power tool handpiece designed to connect between a dental power tool motor and an endpiece to transfer mechanical energy from the motor to the endpiece during a dental surgical procedure. It may be in the form of a torque multiplier, adapter, or motorless handpiece. Neither the motor nor the endpiece is included. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K940261	000

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

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: e359906c-1abc-41fd-a1ff-d285bbbd67a4
Public Version Date: February 20, 2023
Public Version Number: 1
DI Record Publish Date: February 10, 2023