Mectron S1-S

Mectron S1-S (02960009) 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 7 Mar 2018 (UDI-DI E322029600090), 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	NumberE322029600090 UDI-DI	Date7 Mar 2018Listed	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 E322029600090 listed 7 Mar 2018 Listed

Timeline

2 dated events

5 Aug 2015 Cleared FDA 510(k) K151023
7 Mar 2018 Listed FDA GUDID E322029600090

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Withdrawn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 handpiece tip, periodontal
Model / Ref / Catalog: S1-S, 02960009

Primary DI / UDI-DI: E322029600090
510(k) Number: K151023
FDA product code: ELC
GMDN term: Ultrasonic dental scaling/debridement system handpiece tip, periodontal

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

Sterilisation method: Moist Heat or Steam Sterilization

Other devices from Mectron SpA

Mectron OP1125

Class II
Mectron OP1225

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Mectron EX0410

Class II
Mectron EX0510

Class II

See all devices from Mectron SpA →

Properties

Sterilise before use
Prescription use
Lot / batch number

Other properties (12, all answered No)