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ZirClean B-7351

by Bisco Inc.

Ref B-7351

ZirClean B-7351 is a device classified as Class I in the EU and Class II in the US made by Bisco Inc., registered in EUDAMED on 2 Oct 2026 (Basic UDI-DI 081011154ZirCleanTU), cleared under FDA 510(k) K163171 on 14 Apr 2017 and listed in FDA GUDID since 29 Jul 2022 (UDI-DI 00810111542470), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K163171

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081011154ZirCleanTU Basic UDI-DI 00810111542470UDI-DIDate2 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00810111542470 UDI-DI Date29 Jul 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK163171 Date14 Apr 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 081011154ZirCleanTU registered 2 Oct 2026 Active
  • FDA 510(k) K163171 decided 14 Apr 2017 Active
  • FDA GUDID UDI-DI 00810111542470 listed 29 Jul 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K163171
  2. Listed FDA GUDID 00810111542470
  3. Registered EUDAMED 081011154ZirCleanTU

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  • Withdrawn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
ZirClean
Generic name
Dental restoration fixation cleaning solution
Model / Ref / Catalog
B-7351
Primary DI / UDI-DI
00810111542470
Basic UDI-DI
081011154ZirCleanTU
510(k) Number
FDA product code
PME
EMDN code
Q0199 Odontology devices - other
GMDN term
Dental restoration fixation cleaning solution
Device class
Class I EUDAMED
Class II GUDID
Regulation number
872.3260
EU registration type
Standard device
EU market of registration
France
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.

Related devices

Category: Dental restoration fixation cleaning solution

Similar devices in this category

Other devices filed under ODONTOLOGY DEVICES - OTHER.

Other devices from Bisco Inc.

See all devices from Bisco Inc. →

Properties

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