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QSD3285SP

by ZimVie US Corp LLC

Ref QSD3285SP

QSD3285SP 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 3 Jun 2026 (Basic UDI-DI 844868AFJ2) and listed in FDA GUDID since 5 Dec 2019 (UDI-DI 00844868042853), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number844868AFJ2 Basic UDI-DI 00844868042853UDI-DIDate3 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00844868042853 UDI-DI Date5 Dec 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 844868AFJ2 registered 3 Jun 2026 Active
  • FDA GUDID UDI-DI 00844868042853 listed 5 Dec 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00844868042853
  2. Registered EUDAMED 844868AFJ2

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  • Withdrawn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
"Single Patient Quad Shaping Drills "
Generic name
Fixture/appliance dental drill bit, single-use
Device name
Sterile powered surgically invasive instrument
Model / reference
QSD3285SP
Primary DI / UDI-DI
00844868042853
Basic UDI-DI
844868AFJ2
FDA product code
NDP
EMDN code
Q010599 Dental instruments, single-use - other
GMDN term
Fixture/appliance dental drill bit, single-use
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

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: Fixture/appliance dental drill bit, single-use

Similar devices in this category

Other devices filed under DENTAL INSTRUMENTS, SINGLE-USE - OTHER.

Other devices from ZimVie US Corp LLC

See all devices from ZimVie US Corp LLC →

Properties

  • Supplied sterile
  • Single use
  • Reusable
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)