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Mectron MF1004L

by Mectron SpA

Mectron MF1004L (03630009) is a Class II device made by Mectron SpA, cleared under FDA 510(k) K153743 on 25 May 2016 and listed in FDA GUDID since 20 Apr 2026 (UDI-DI E322036300090), active as of 23 Oct 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 23 Oct 2026

Documents

510(k) K153743

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberE322036300090 UDI-DI Date20 Apr 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK153743 Date25 May 2016IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K153743 decided 25 May 2016 Active
  • FDA GUDID UDI-DI E322036300090 listed 20 Apr 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K153743
  2. Listed FDA GUDID E322036300090

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Mectron
Generic name
Dental ultrasonic surgical system handpiece tip
Model / Ref / Catalog
MF1004L, 03630009
Primary DI / UDI-DI
E322036300090
510(k) Number
FDA product code
DZI, HWE, HBE, ERL, JDX
GMDN term
Dental ultrasonic surgical system handpiece tip
Device class
Class II
Regulation number
872.4120, 878.4820, 882.4310, 874.4250, 888.4580
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K153743)

and 8 more cleared under K153743

Other devices from Mectron SpA

  • Mectron OP1125

    Class II

  • Mectron OP1225

    Class II

  • Mectron EX0410

    Class II

  • Mectron EX0510

    Class II

See all devices from Mectron SpA →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)