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EsBond 101-0501

by Spident Co., Ltd.

Ref #370200

EsBond 101-0501 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 9 Jun 2026 (Basic UDI-DI 880926295EBZF), cleared under FDA 510(k) K120767 on 24 May 2012 and listed in FDA GUDID since 20 Feb 2017 (UDI-DI 08809262955415), active as of 23 Oct 2026.

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

CE MDR CE MDD 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K120767

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED Number880926295EBZF Basic UDI-DI 08809262955415UDI-DIDate9 Jun 2026RegisteredStatusActive
European UnionCE/MDR EUDAMED Number880926295EBZF Basic UDI-DI 08809262955415UDI-DIDate9 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809262955415 UDI-DI Date20 Feb 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK120767 Date24 May 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 880926295EBZF registered 9 Jun 2026 Active· +1 more in the status table
  • FDA 510(k) K120767 decided 24 May 2012 Active
  • FDA GUDID UDI-DI 08809262955415 listed 20 Feb 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K120767
  2. Listed FDA GUDID 08809262955415
  3. Registered EUDAMED 880926295EBZF

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
EsBond refill EUDAMED
EsBond GUDID
Generic name
Dentine bonding agent/set
Model / Ref / Catalog
#370200 EUDAMED
101-0501 GUDID
Primary DI / UDI-DI
08809262955415
Basic UDI-DI
880926295EBZF, B-08809262955415
Direct marketing DI
08809262955415
510(k) Number
FDA product code
KLE
EMDN code
Q01010104 Dental bonding agents
GMDN term
Dentine bonding agent/set
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3200
EU registration type
Standard device
Legacy device (under a directive)
EU market of registration
Greece
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
#370200
GUDID
101-0501
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: Dentine bonding agent/set

Similar devices in this category

Other devices filed under DENTAL BONDING AGENTS.

Other devices from Spident Co., Ltd.

See all devices from Spident Co., Ltd. →

Properties

  • Implantable YesEUDAMEDNoGUDID
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (21, all answered No)