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ZirClean B-7351P

by Bisco Inc.

Ref B-7351P

ZirClean B-7351P is a Class I device made by Bisco Inc., registered in EUDAMED on 2 Oct 2026 (Basic UDI-DI 081011154ZirCleanTU) and listed in FDA GUDID since 29 Jul 2022 (UDI-DI 00810111542487), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081011154ZirCleanTU Basic UDI-DI 00810111542487UDI-DIDate2 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00810111542487 UDI-DI Date29 Jul 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081011154ZirCleanTU registered 2 Oct 2026 Active
  • FDA GUDID UDI-DI 00810111542487 listed 29 Jul 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00810111542487
  2. Registered EUDAMED 081011154ZirCleanTU

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  • Withdrawn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
ZirClean
Generic name
Dental restoration fixation cleaning solution
Model / Ref / Catalog
B-7351P
Primary DI / UDI-DI
00810111542487
Basic UDI-DI
081011154ZirCleanTU
FDA product code
EID, PME
EMDN code
Q0199 Odontology devices - other
GMDN term
Dental restoration fixation cleaning solution
Device class
Class I
Regulation number
872.4565, 872.3260
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

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
  • Manufacturing date
Other properties (21, all answered No)