Mectron PD0328A

Mectron PD0328A (04800003) is a Class II device made by Mectron SpA, cleared under FDA 510(k) K242432 on 19 Aug 2024 and listed in FDA GUDID since 16 Sep 2024 (UDI-DI E322048000030), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberE322048000030 UDI-DI	Date16 Sep 2024Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK242432	Date19 Aug 2024Decided	StatusActive

Official records

FDA 510(k) database 510(k) number K242432

Across registries

2 registries list this device

FDA 510(k) K242432 decided 19 Aug 2024 Active
FDA GUDID UDI-DI E322048000030 listed 16 Sep 2024 Listed

Timeline

2 dated events

19 Aug 2024 Cleared FDA 510(k) K242432
16 Sep 2024 Listed FDA GUDID E322048000030

Coverage

1 jurisdiction

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Withdrawn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: PD0328A, 04800003

Primary DI / UDI-DI: E322048000030
510(k) Number: K242432
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

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Properties

Sterilise before use
Prescription use
Lot / batch number

Other properties (12, all answered No)