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EsFlow PLUS #3306A1P04

by Spident Co., Ltd.

Part of a family of 71 devices: see the family page

Ref #3306A1P04

EsFlow PLUS #3306A1P04 is a device classified as Class IIa in the EU and Class II in the US made by Spident Co., Ltd., registered in EUDAMED on 28 May 2026 (Basic UDI-DI 880926295SEPUB), cleared under FDA 510(k) K250317 on 30 May 2025 and listed in FDA GUDID since 31 Jul 2025 (UDI-DI 08809262950427), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K250317

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number880926295SEPUB Basic UDI-DI 08809262950427UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809262950427 UDI-DI Date31 Jul 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK250317 Date30 May 2025DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 880926295SEPUB registered 28 May 2026 Active
  • FDA 510(k) K250317 decided 30 May 2025 Active
  • FDA GUDID UDI-DI 08809262950427 listed 31 Jul 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K250317
  2. Listed FDA GUDID 08809262950427
  3. Registered EUDAMED 880926295SEPUB

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
EsFlow PLUS A1 EUDAMED
EsFlow PLUS GUDID
Generic name
Dental composite resin
Model / reference
#3306A1P04
Primary DI / UDI-DI
08809262950427
Basic UDI-DI
880926295SEPUB
Direct marketing DI
08809262950427
510(k) Number
FDA product code
EBF
EMDN code
Q01010103 Dental restorative composites
GMDN term
Dental composite resin
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3690
EU registration type
Standard device
EU market of registration
Greece
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Dental composite resin

Cleared under the same submission (K250317)

and 8 more cleared under K250317

Similar devices in this category

Other devices filed under DENTAL RESTORATIVE COMPOSITES.

Other devices from Spident Co., Ltd.

See all devices from Spident Co., Ltd. →

Properties

  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (20, all answered No)