AccessGUDID - DEVICE: Lynx Scalemaster (D826LX3004H091)

GUDID

Device Identifier (DI) Information

Brand Name: Lynx Scalemaster
Version or Model: LX3004H09
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MTI Precision Products, LLC

Primary DI Number: D826LX3004H091
Issuing Agency: HIBCC
Commercial Distribution End Date: December 31, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 081600128 *Terms of Use

Device Description: The Lynx Scalemaster in an ultrasonic scaler a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits for teeth by application of a sonic vibrating scaler tip to the teeth.

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):	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?
31885	Rotary dental scaler	An abrasive device intended to be attached to a powered dental handpiece that provides rotation and is used to remove calculus deposits and other accretions from tooth surfaces during dental cleaning and periodontal (gum) therapy. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ELC	Scaler, Ultrasonic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K901488	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: a00642d2-8962-4764-b5b9-34a487ac7ed9
Public Version Date: March 23, 2022
Public Version Number: 4
DI Record Publish Date: September 22, 2016