Ena HRI ® EFFUD3, 5

by Micerium SpA

Ena HRI ® EFFUD3, 5 (EFFUD3,5) is a Class II device made by Micerium SpA, cleared under FDA 510(k) K062906 on 17 Nov 2006 and listed in FDA GUDID since 5 Dec 2016 (UDI-DI EMICEFFUD350), active as of 22 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 22 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberEMICEFFUD350 UDI-DI	Date5 Dec 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK062906	Date17 Nov 2006Decided	StatusActive

Official records

FDA 510(k) database 510(k) number K062906

Across registries

2 registries list this device

FDA 510(k) K062906 decided 17 Nov 2006 Active
FDA GUDID UDI-DI EMICEFFUD350 listed 5 Dec 2016 Listed

Timeline

2 dated events

17 Nov 2006 Cleared FDA 510(k) K062906
5 Dec 2016 Listed FDA GUDID EMICEFFUD350

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Ena HRI ®
Generic name: Dental composite resin
Model / Ref / Catalog: EFFUD3, 5
Description: Ena HRi Flow UD3.5 1g Light Curing Composite

Primary DI / UDI-DI: EMICEFFUD350
510(k) Number: K062906
FDA product code: EBF
GMDN term: Dental composite resin

Device class: Class II
Regulation number: 872.3690
GUDID distribution status: In Commercial Distribution

Size: Weight — 1 Gram

Other devices from Micerium SpA

See all devices from Micerium SpA →

Properties

Lot / batch number
Expiration date

Other properties (13, all answered No)