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EsCom100 A2

by Spident

Part of a family of 68 devices: see the family page

Ref #3102A2

EsCom100 A2 (#3102A2) is a device classified as Class IIa in the EU and Class II in the US made by Spident, registered in EUDAMED on 9 Apr 2026 (Basic UDI-DI B-08809262955224), cleared under FDA 510(k) K110428 on 25 Feb 2011 and listed in FDA GUDID since 20 Feb 2017 (UDI-DI 08809262955224), active as of 25 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K110428

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberB-08809262955224 Basic UDI-DI 08809262955224UDI-DIDate9 Apr 2026RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-08809262955224 Basic UDI-DI 08809262955224UDI-DIDate9 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809262955224 UDI-DI Date20 Feb 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK110428 Date25 Feb 2011DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08809262955224 registered 9 Apr 2026 Active· +1 more in the status table
  • FDA 510(k) K110428 decided 25 Feb 2011 Active
  • FDA GUDID UDI-DI 08809262955224 listed 20 Feb 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K110428
  2. Listed FDA GUDID 08809262955224
  3. Registered EUDAMED B-08809262955224

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
EsCom100 A2 EUDAMED
EsCom100 A2 Syringe GUDID
Generic name
Dental composite resin
Device name
Escom100
Model / Ref / Catalog
#3102A2 EUDAMED
101-0702 GUDID
Primary DI / UDI-DI
08809262955224
Basic UDI-DI
B-08809262955224, 880926295EFZP
Direct marketing DI
08809262955224
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
Legacy device (under a directive)
Standard device
EU market of registration
Bulgaria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
#3102A2
GUDID
101-0702
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.

Manufacturer details

EUDAMED SRN
KR-MF-000008691
Authorised representative
AR Experts B.V. NL-AR-000023989

Related devices

Category: Dental composite resin

Similar devices in this category

Other devices filed under DENTAL RESTORATIVE COMPOSITES.

Other devices from Spident

See all devices from Spident →

Properties

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