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BPT3535

by ZimVie US Corp LLC

Part of a family of 271 devices: see the family page

Ref BPT3535

BPT3535 is a device classified as Class IIa in the EU and Class I in the US made by ZimVie US Corp LLC, registered in EUDAMED on 8 Jun 2026 (Basic UDI-DI 844868AEHY) and listed in FDA GUDID since 2 Apr 2021 (UDI-DI 00844868039051), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number844868AEHY Basic UDI-DI 00844868039051UDI-DIDate8 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00844868039051 UDI-DI Date2 Apr 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 844868AEHY registered 8 Jun 2026 Active
  • FDA GUDID UDI-DI 00844868039051 listed 2 Apr 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00844868039051
  2. Registered EUDAMED 844868AEHY

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  • Withdrawn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
Bone Profilers
Generic name
Steel dental bur, reusable
Device name
Non-Sterile powered surgically invasive instrument
Model / reference
BPT3535
Primary DI / UDI-DI
00844868039051
Basic UDI-DI
844868AEHY
FDA product code
NDP
EMDN code
L159099 Odontostomatology instruments, reusable - other
GMDN term
Steel dental bur, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.3980
EU registration type
Standard device
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

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: Steel dental bur, reusable

Similar devices in this category

Other devices filed under ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER.

Other devices from ZimVie US Corp LLC

See all devices from ZimVie US Corp LLC →

Properties

  • Sterilise before use
  • Reusable
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (18, all answered No)