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Bite block 10 pcs

by PaloDEx Group Oy

Ref 901013

Bite block 10 pcs (901013) is a seizure bite block (EU MDR Class I; FDA Class I; FDA product code EHA, Aligner, Beam, X-Ray) made by PaloDEx Group Oy, registered in EUDAMED on 21 Nov 2025 (Basic UDI-DI 643003587PatPosXL), cleared under FDA 510(k) K180947 on 7 Jun 2018 and listed in FDA GUDID since 26 May 2021 (UDI-DI 06430035874354), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

1 ongoing

Recall on shared 510(k) K180947; other models may be affected

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K180947

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number643003587PatPosXL Basic UDI-DI 06430035874354UDI-DIDate21 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number06430035874354 UDI-DI Date26 May 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK180947 Date7 Jun 2018IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 643003587PatPosXL registered 21 Nov 2025 Active
  • FDA 510(k) K180947 decided 7 Jun 2018 Active
  • FDA GUDID UDI-DI 06430035874354 listed 26 May 2021 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1101-2019 FDA Class II initiated 31 Dec 2018 on shared 510(k) K180947

    ORTHOPANTOMOGRAPH OP 3D device has a defect in the device firmware versions 2.1.0 and 2.1.1

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

4 dated events

  1. Cleared FDA 510(k) K180947
  2. Recall initiated FDA recalls Z-1101-2019
  3. Listed FDA GUDID 06430035874354
  4. Registered EUDAMED 643003587PatPosXL

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Bite block 10 pcs EUDAMED
Bite blocks 10pcs OP 3D GUDID
Generic name
Seizure bite block
Device name
Patient Positioning Accessory
Model / reference
901013
Primary DI / UDI-DI
06430035874354
Basic UDI-DI
643003587PatPosXL
510(k) Number
FDA product code
EHA
EMDN code
Z11030580 Radiology instruments - hardware accessories
GMDN term
Seizure bite block
Device class
Class I
Regulation number
872.1820
EU registration type
Standard device
EU market of registration
Finland
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
FI-MF-000004943

Similar devices in this category

Other devices filed under RADIOLOGY INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from PaloDEx Group Oy

See all devices from PaloDEx Group Oy →

Properties

  • Lot / batch number
  • Manufacturing date
Other properties (23, all answered No)