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Mectron OP1125

by Mectron SpA

Mectron OP1125 (03380015) is a Class II device made by Mectron SpA, cleared under FDA 510(k) K151248 on 4 Sep 2015 and listed in FDA GUDID since 18 Feb 2026 (UDI-DI E322033800150), 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) K151248

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 NumberE322033800150 UDI-DI Date18 Feb 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK151248 Date4 Sep 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K151248 decided 4 Sep 2015 Active
  • FDA GUDID UDI-DI E322033800150 listed 18 Feb 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K151248
  2. Listed FDA GUDID E322033800150

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  • Withdrawn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
OP1125, 03380015
Primary DI / UDI-DI
E322033800150
510(k) Number
FDA product code
DZI, ELC
GMDN term
Dental ultrasonic surgical system handpiece tip
Device class
Class II
Regulation number
872.4120, 872.4850
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K151248)

and 8 more cleared under K151248

Other devices from Mectron SpA

  • Mectron OP1225

    Class II

  • Mectron EX0410

    Class II

  • Mectron EX0510

    Class II

  • Mectron EX0610

    Class II

See all devices from Mectron SpA →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)