DEVICE: Medidenta Air Free 90 Titan (D884AFT900)

Device Identifier (DI) Information

Medidenta Air Free 90 Titan
AFT90
In Commercial Distribution

Flight Dental Systems
D884AFT900
HIBCC

1
241275150 *Terms of Use
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
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

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
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FDA Product Code

[?]
Product Code Product Code Name
EFB Handpiece, Air-Powered, Dental
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K181691 000
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

7abbd420-5257-4437-a1f2-1cad843cf86b
February 18, 2021
1
February 10, 2021
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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