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SS White

by SS White Burs LLC 22 variants

Ref 310211Model Carbide Bur

SS White (310211) 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-D6903102112) and listed in FDA GUDID since 16 Feb 2026 (UDI-DI D6903102112), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-D6903102112 Basic UDI-DI D6903102112UDI-DIDate20 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD6903102112 UDI-DI Date16 Feb 2026ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-D6903102112 registered 20 Jul 2026 Active
  • FDA GUDID UDI-DI D6903102112 listed 16 Feb 2026 Listed

Timeline

2 dated events

  1. Listed FDA GUDID D6903102112
  2. Registered EUDAMED B-D6903102112

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  • Withdrawn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, single-use
Model / Ref / Catalog
Carbide Bur, 310211, FG-PBUR-2P
Primary DI / UDI-DI
D6903102112
Basic UDI-DI
B-D6903102112
FDA product code
EJL
EMDN code
Q010501 Dental burs and abrasive disks, single-use
GMDN term
Carbide dental bur, single-use
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
310211
GUDID
FG-PBUR-2P
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 D6903102112: 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.

Manufacturer details

EUDAMED SRN
US-MF-000018262
Authorised representative
Obelis s.a. BE-AR-000000106

Similar devices in this category

Other devices filed under DENTAL DEVICES.

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
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)