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Silane 410

by Ultradent Products, Inc.

Ref 410

Silane 410 is a device classified as Class IIa in the EU and Class II in the US made by Ultradent Products, Inc., registered in EUDAMED on 29 May 2026 (Basic UDI-DI 0883205-TF052Silane5S), cleared under FDA 510(k) K921409 on 9 Sep 1992 and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 00883205103628), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K921409

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/MDR EUDAMED Number0883205-TF052Silane5S Basic UDI-DI 00883205103628UDI-DIDate29 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00883205103628 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK921409 Date9 Sep 1992DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0883205-TF052Silane5S registered 29 May 2026 Active
  • FDA 510(k) K921409 decided 9 Sep 1992 Active
  • FDA GUDID UDI-DI 00883205103628 listed 22 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K921409
  2. Listed FDA GUDID 00883205103628
  3. Registered EUDAMED 0883205-TF052Silane5S

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  • Withdrawn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
Silane
Generic name
Dental tooth-etching solution
Model / Ref / Catalog
410
Primary DI / UDI-DI
00883205103628
Basic UDI-DI
0883205-TF052Silane5S
510(k) Number
FDA product code
EBF
EMDN code
Q01010402 Enamel-dentinal etching materials
GMDN term
Dental tooth-etching solution
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3690
EU registration type
Standard device
EU market of registration
Germany
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 etching solution

Similar devices in this category

Other devices filed under ENAMEL-DENTINAL ETCHING MATERIALS.

Other devices from Ultradent Products, Inc.

See all devices from Ultradent Products, Inc. →

Properties

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