Mectron Compact-Piezo P2K LED

Mectron Compact-Piezo P2K LED (04000091) is a Class II device made by Mectron SpA, cleared under FDA 510(k) K151023 on 5 Aug 2015 and listed in FDA GUDID since 30 Aug 2016 (UDI-DI E322040000910), 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	NumberE322040000910 UDI-DI	Date30 Aug 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK151023	Date5 Aug 2015Decided	StatusActive

Official records

FDA 510(k) database 510(k) number K151023

Across registries

2 registries list this device

FDA 510(k) K151023 decided 5 Aug 2015 Active
FDA GUDID UDI-DI E322040000910 listed 30 Aug 2016 Listed

Timeline

2 dated events

5 Aug 2015 Cleared FDA 510(k) K151023
30 Aug 2016 Listed FDA GUDID E322040000910

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Mectron
Generic name: Ultrasonic dental scaling/debridement system
Model / Ref / Catalog: COMPACT-PIEZO P2K LED, 04000091

Primary DI / UDI-DI: E322040000910
510(k) Number: K151023
FDA product code: ELC
GMDN term: Ultrasonic dental scaling/debridement system

Device class: Class II
Regulation number: 872.4850
GUDID distribution status: In Commercial Distribution

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Properties

Prescription use
Serial number

Other properties (13, all answered No)