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Disposable Prophy Angles, 90° Right Angle, Ribbed and Webbed

by Premium Plus (Dongguan) Limited 2 variants

Ref 3399-090SG

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number+D1253399090SG2 UDI-DI Date9 Apr 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number++D125PROPHYANGLESTN Basic UDI-DI +D1253399090SG2UDI-DIDate9 Jan 2026RegisteredStatusActive

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
Disposable Prophy Angles, 90° Right Angle, Ribbed and Webbed EUDAMED
Premium Plus GUDID
Generic Name
Dental polishing cup, single-use
Device Name
Dental Prophy Angles
Model / Reference
3399-090SG
Primary DI / UDI-DI
+D1253399090SG2 EUDAMED
D1253399090SG2 GUDID
Basic UDI-DI
++D125PROPHYANGLESTN
Unit of Use DI
2
510(k) Number
FDA Product Code
EGS
EMDN Code
Q010502 Dental polishing cups, single-use
GMDN Term
Dental polishing cup, single-use
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
872.4200
EU market of registration
Poland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
+D1253399090SG2
GUDID
D1253399090SG2
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
CN-MF-000038259
Authorised representative
Premium Plus Poland sp. z o.o. PL-AR-000030110

Related devices

Category: Dentifrice

Other devices from Premium Plus (Dongguan) Limited

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Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (20)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No