Mectron PR2

Mectron PR2 (03390005) 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 30 Aug 2016 (UDI-DI E322033900050), 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	NumberE322033900050 UDI-DI	Date30 Aug 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK151248	Date4 Sep 2015Decided	StatusActive

Official records

FDA 510(k) database 510(k) number K151248

Across registries

2 registries list this device

FDA 510(k) K151248 decided 4 Sep 2015 Active
FDA GUDID UDI-DI E322033900050 listed 30 Aug 2016 Listed

Timeline

2 dated events

4 Sep 2015 Cleared FDA 510(k) K151248
30 Aug 2016 Listed FDA GUDID E322033900050

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Withdrawn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: PR2, 03390005

Primary DI / UDI-DI: E322033900050
510(k) Number: K151248
FDA product code: ELC, DZI
GMDN term: Dental ultrasonic surgical system handpiece tip

Device class: Class II
Regulation number: 872.4850, 872.4120
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

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See all devices from Mectron SpA →

Properties

Sterilise before use
Prescription use
Lot / batch number

Other properties (12, all answered No)