Skip to content

Precise Bite™ MTCBPBITETD

by Medtec LLC

Ref MTCBPBITETDModel Head, Neck, and Shoulder Devices

Precise Bite MTCBPBITETD is a radiological head/neck positioning mouthpiece (EU MDR Class I; FDA Class II) made by Medtec LLC, registered in EUDAMED on 22 May 2026 (Basic UDI-DI 8414391OC0005R05AY), cleared under FDA 510(k) K093738 on 14 May 2010 (1 earlier submission) and listed in FDA GUDID since 2 Aug 2017 (UDI-DI 00841439104088), active as of 22 Oct 2026. 2 FDA recalls are linked to it.

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

None ongoing

2 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K093738

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8414391OC0005R05AY Basic UDI-DI 00841439104088UDI-DIDate22 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841439104088 UDI-DI Date2 Aug 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK093738 Date14 May 2010DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 8414391OC0005R05AY registered 22 May 2026 Active
  • FDA 510(k) K093738 decided 14 May 2010 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00841439104088 listed 2 Aug 2017 Listed

Recalls

2 recalls · FDA

    • Terminated Z-2243-2020 FDA Class II initiated 12 May 2020

    Potential for disengagement of the Varian Style Type-S Extension during patient repositioning. The risk associated with the disengagement of the extension could be a patient fall if the patient is not supported by clinical staff.

    • Terminated Z-0124-2010 FDA Unclassified (pre-2012) initiated 31 Aug 2009

    Some of the packages contain the incorrect mask style.

Timeline

6 dated events

  1. Cleared FDA 510(k) K933227
  2. Recall initiated FDA recalls Z-0124-2010
  3. Cleared FDA 510(k) K093738
  4. Listed FDA GUDID 00841439104088
  5. Recall initiated FDA recalls Z-2243-2020
  6. Registered EUDAMED 8414391OC0005R05AY

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
Precise Bite™
Generic name
Radiological head/neck positioning mouthpiece
Model / Ref / Catalog
MTCBPBITETD, Head, Neck, and Shoulder Devices
Primary DI / UDI-DI
00841439104088
Basic UDI-DI
8414391OC0005R05AY
510(k) Number
FDA product code
IYE, LNH
EMDN code
Z12011299 Patient positioning instruments – other
GMDN term
Radiological head/neck positioning mouthpiece
Device class
Class I EUDAMED
Class II GUDID
Regulation number
892.5050, 892.1000
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

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

Related devices

Category: Radiological head/neck positioning mouthpiece

Cleared under the same submission (K093738)

and 8 more cleared under K093738

Cleared under the same submission (K933227)

and 8 more cleared under K933227

Similar devices in this category

Other devices filed under PATIENT POSITIONING INSTRUMENTS – OTHER.

Other devices from Medtec LLC

See all devices from Medtec LLC →

Properties

  • Reusable
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)