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HySil

by OSSTEM IMPLANT Co., Ltd.

Part of a family of 7 devices: see the family page

Ref ESS50H

HySil (ESS50H) is a device classified as Class I in the EU and Class II in the US made by Osstem Implant Co., Ltd, registered in EUDAMED on 25 Feb 2026 (Basic UDI-DI 00406CLASSISH2AM), cleared under FDA 510(k) K170736 on 7 Jun 2017 and listed in FDA GUDID since 17 Nov 2020 (UDI-DI 08800040673958), active as of 25 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K170736

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 Number00406CLASSISH2AM Basic UDI-DI 08800040673958UDI-DIDate25 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800040673958 UDI-DI Date17 Nov 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK170736 Date7 Jun 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 00406CLASSISH2AM registered 25 Feb 2026 Active
  • FDA 510(k) K170736 decided 7 Jun 2017 Active
  • FDA GUDID UDI-DI 08800040673958 listed 17 Nov 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K170736
  2. Listed FDA GUDID 08800040673958
  3. Registered EUDAMED 00406CLASSISH2AM

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  • Withdrawn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
HySil EUDAMED
HySil Impression Materials GUDID
Generic name
Silicone dental impression material
Device name
Impression Material System
Model / reference
ESS50H
Primary DI / UDI-DI
08800040673958
Basic UDI-DI
00406CLASSISH2AM
510(k) Number
FDA product code
ELW
EMDN code
Q01020102 Dental impression vinylsiloxans
GMDN term
Silicone dental impression material
Device class
Class I EUDAMED
Class II GUDID
Regulation number
872.3660
EU registration type
Standard device
EU market of registration
Czechia
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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-000020005
Authorised representative
Obelis s.a. BE-AR-000000106

Related devices

Category: Dental implant suprastructure, temporary, preformed, single-use

Similar devices in this category

Other devices filed under DENTAL IMPRESSION VINYLSILOXANS.

Other devices from Osstem Implant Co., Ltd

See all devices from Osstem Implant Co., Ltd →

Properties

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