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Ssw Carbide Hp-Pbur-2

by SS White Burs LLC 2 variants

Ref 12002Model Carbide Bur

Ssw Carbide Hp-Pbur-2 (12002) is a device classified as Class IIa in the EU and Class I in the US made by SS White Burs LLC, registered in EUDAMED on 20 Jul 2026 (Basic UDI-DI B-D690120022) and listed in FDA GUDID since 18 Feb 2025 (UDI-DI D690120022), active as of 25 Oct 2026.

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

CE MDD

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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-D690120022 Basic UDI-DI D690120022UDI-DIDate20 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD690120022 UDI-DI Date18 Feb 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-D690120022 registered 20 Jul 2026 Active
  • FDA GUDID UDI-DI D690120022 listed 18 Feb 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID D690120022
  2. Registered EUDAMED B-D690120022

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
SS White EUDAMED
Ssw Carbide GUDID
Generic name
Carbide dental bur, reusable
Model / Ref / Catalog
Carbide Bur, 12002, HP-PBUR-2
Primary DI / UDI-DI
D690120022
Basic UDI-DI
B-D690120022
FDA product code
EJL
EMDN code
Q010501 Dental burs and abrasive disks, single-use
GMDN term
Carbide dental bur, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.3240
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Carbide Bur
12002
GUDID
HP-PBUR-2
Device classEUDAMED
Class IIa
GUDID
Class I
Sterilise before useEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI D690120022: EUDAMED states Yes, FDA GUDID states No.

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

Related devices

Category: Carbide dental bur, reusable

Similar devices in this category

Other devices filed under DENTAL BURS AND ABRASIVE DISKS, SINGLE-USE.

Other devices from SS White Burs LLC

See all devices from SS White Burs LLC →

Properties

  • Sterilise before use YesEUDAMEDNoGUDID
  • Single use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)