AccessGUDID - DEVICE: Flight Dental Systems (D884FMS25300)

GUDID

Device Identifier (DI) Information

Brand Name: Flight Dental Systems
Version or Model: FMS-2530
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Flight Magnetostrictive TableTop Ultrasonic Scaler
Company Name: Flight Dental Systems

Primary DI Number: D884FMS25300
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 241275150 *Terms of Use

Device Description: The Flight Magnetostrictive Ultrasonic Scaler is designed for use in prophylaxis treatments periodontal, endodontics and other areas of operative dentistry. When used in prophylaxis treatment, the unit operates with a fine warm water spray, requiring little of the physical exertion necessary with hand instruments. It easily and effectively removes stubborn calculus and stains both supra gingival and sub gingival, leaving crown and root surfaces clean and smooth.

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?
44907	Ultrasonic dental scaling/debridement system handpiece	A hand-held component of an ultrasonic dental debridement system intended to convert high frequency electrical current from a generator into an ultrasonic oscillation, for a tip placed at its end to mechanically fragment and dislodge gross debris/accretions during an endodontic and/or periodontal procedure. It may also serve as a conduit for fluid intended to prevent overheating of the tip and surrounding tissue. This device is typically in the form of a pen/pencil with attached cables. This is a reusable device.	Active	false
44906	Ultrasonic dental scaling/debridement system generator	A mains electricity (AC-powered) unit that functions as part of an ultrasonic dental scaling/debridement system, intended to generate, and enable control of, ultrasonic oscillations to: 1) mechanically fragment and dislodge gross debris in the dental pulp canal during an endodontic procedure; and/or 2) remove accretions from tooth surfaces during dental cleaning/periodontal therapy. It connects to the system handpiece, and may connect to a suitable water supply, or it may contain the water or rinsing solution (e.g., chlorhexidine) source.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ELC	Scaler, Ultrasonic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K040396	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: c2b873ba-989b-417e-acb6-98097211e056
Public Version Date: August 17, 2020
Public Version Number: 1
DI Record Publish Date: August 07, 2020