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575050 Zooby Disposable Prophy Angles, Assorted, 500ct X 1 plus 1 x 295738 (Adapter / Handpiece)

by Young Dental Manufacturing I, LLC

Ref ZB01

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

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number03027346938EGSD02064QQ Basic UDI-DI 10302730002956UDI-DIDate26 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10302730002956 UDI-DI Date19 Sep 2024ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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
575050 Zooby Disposable Prophy Angles, Assorted, 500ct X 1 plus 1 x 295738 (Adapter / Handpiece) EUDAMED
Young GUDID
Generic Name
Dental polishing cup, single-use
Device Name
Disposable Prophylaxis Angle Kits
Model / Ref / Catalog
ZB01
Primary DI / UDI-DI
10302730002956 EUDAMED
00302730002959 GUDID
Basic UDI-DI
03027346938EGSD02064QQ
FDA Product Code
EGS
EMDN Code
Q010399 Surgical dental devices - other
GMDN Term
Dental polishing cup, single-use
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
872.4200
Medical Purpose
Disposable Prophylaxis Angle used to clean and polish teeth
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
10302730002956
GUDID
00302730002959
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
US-PR-000056443

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Properties

  • Single Use
  • Prescription Use
  • Convenience Kit
  • Combination Product
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (7)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No