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Master Prophy Airlite 50154-03

by MTI Precision Products, LLC

Master Prophy Airlite 50154-03 is a Class I device made by MTI Precision Products, LLC, cleared under FDA 510(k) K070001 on 2 Feb 2007 and listed in FDA GUDID since 10 Feb 2023 (UDI-DI D8265015403), active as of 8 Nov 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 8 Nov 2026

Documents

510(k) K070001

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD8265015403 UDI-DI Date10 Feb 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK070001 Date2 Feb 2007DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K070001 decided 2 Feb 2007 Active
  • FDA GUDID UDI-DI D8265015403 listed 10 Feb 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K070001
  2. Listed FDA GUDID D8265015403

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Master Prophy Airlite
Generic name
Dental surgical power tool motor, pneumatic
Model / reference
50154-03
Primary DI / UDI-DI
D8265015403
510(k) Number
FDA product code
EFB
GMDN term
Dental surgical power tool motor, pneumatic
Device class
Class I
Regulation number
872.4200
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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Properties

  • Sterilise before use
  • Prescription use
  • Serial number
Other properties (12, all answered No)