AccessGUDID - DEVICE: Medidenta Air Free 90 Titan (D884AFT900)

GUDID

Device Identifier (DI) Information

Brand Name: Medidenta Air Free 90 Titan
Version or Model: AFT90
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Flight Dental Systems

Primary DI Number: D884AFT900
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 241275150 *Terms of Use

Device Description: The Air-Free does not allow any air to vent out of the head of the handpiece. This will eliminate air sensitivity and patient discomfort during removal of bonding adhesive (i.e. Invisalign attachments); providing your patients with a pain and stress free appointment

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?
40958	Dental power tool system handpiece, pneumatic	A hand-held dental device that includes a chuck for attaching a rotary dental endpiece (e.g., drill bits, burs, reamers) intended to be used in dentistry to bore/excavate bones, teeth, and tough tissues. The device incorporates a small turbine motor normally driven by compressed air, and which typically has a built-in water spray for cooling the rotating device; the endpiece(s) are not included. The handpiece is typically connected through the dental delivery system or a freestanding independent system. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
EFB	Handpiece, Air-Powered, Dental

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K181691	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: 7abbd420-5257-4437-a1f2-1cad843cf86b
Public Version Date: February 18, 2021
Public Version Number: 1
DI Record Publish Date: February 10, 2021