Skip to content

ViscoStat Clear S646

by Ultradent Products, Inc.

Ref S646

ViscoStat Clear S646 is a device classified as Class IIa (EU), Unclassified (US) made by Ultradent Products, Inc., registered in EUDAMED on 29 May 2026 (Basic UDI-DI 0883205-TF172B9) and listed in FDA GUDID since 7 Nov 2022 (UDI-DI 00883205035707), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0883205-TF172B9 Basic UDI-DI 00883205035707UDI-DIDate29 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00883205035707 UDI-DI Date7 Nov 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0883205-TF172B9 registered 29 May 2026 Active
  • FDA GUDID UDI-DI 00883205035707 listed 7 Nov 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00883205035707
  2. Registered EUDAMED 0883205-TF172B9

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
ViscoStat Clear
Generic name
Gingival retraction solution
Model / Ref / Catalog
S646
Primary DI / UDI-DI
00883205035707
Basic UDI-DI
0883205-TF172B9
FDA product code
MVL
EMDN code
M040504 Inorganic haemostatic devices
GMDN term
Gingival retraction solution
Device class
Class IIa EUDAMED
U GUDID
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
U

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

Similar devices in this category

Other devices filed under INORGANIC HAEMOSTATIC DEVICES.

Other devices from Ultradent Products, Inc.

See all devices from Ultradent Products, Inc. →

Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (22, all answered No)