# Precise Bite™ MTCBPBITETDS

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/precise-bite-mtcbpbitetds>
- Manufacturer: [Medtec LLC](https://devicerts.com/manufacturers/medtec-llc) (United States)
- Device class: Class I (EU MDR); Class II (US FDA)
- FDA product code: IYE, LNH
- EMDN: Z12011299 PATIENT POSITIONING INSTRUMENTS – OTHER
- GMDN: Radiological head/neck positioning mouthpiece (61130)

## Registrations and authorizations

- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI 8414391OC0005R05AY · UDI-DI 00841439104095 · registered 2026-05-22 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI 00841439104095 · listed 2017-08-02 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K093738 · decision 2010-05-14 · decision SESE · status: Active · from GUDID
- **GUDID** · FDA 510(k) · United States · K933227 · decision 1994-07-18 · decision SESE · status: Active · from GUDID

## Recalls

- Z-2243-2020 · Class II · terminated · initiated 2020-05-12: 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.
- Z-0124-2010 ·  · terminated · initiated 2009-08-31: Some of the packages contain the incorrect mask style.

## Identity

- Trade name: Precise Bite™ [FDA GUDID (AccessGUDID)]
- Generic name: Radiological head/neck positioning mouthpiece [FDA GUDID (AccessGUDID)]
- Model / Ref / Catalog: MTCBPBITETDS [EUDAMED, FDA GUDID (AccessGUDID)]; Head [EUDAMED]; Neck [EUDAMED]; and Shoulder Devices [EUDAMED]

## Identifiers

- Primary DI / UDI-DI: 00841439104095 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: 8414391OC0005R05AY [EUDAMED]
- 510(k) Number: K093738 [FDA GUDID (AccessGUDID)]; K933227 [FDA GUDID (AccessGUDID)]
- FDA product code: IYE [FDA GUDID (AccessGUDID)]; LNH [FDA GUDID (AccessGUDID)]
- EMDN code: Z12011299 [EUDAMED]
- GMDN term: Radiological head/neck positioning mouthpiece (61130) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class I [EUDAMED]; Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 892.5050 [FDA GUDID (AccessGUDID)]; 892.1000 [FDA GUDID (AccessGUDID)]
- EU registration type: Standard device [EUDAMED]
- EU market of registration: Netherlands [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Clinical & Handling

- MRI safety: MR Safe [FDA GUDID (AccessGUDID)]

## Properties

- Reusable: Yes [EUDAMED]
- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Manufacturing date: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Contains latex: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reprocessed single-use device: No [EUDAMED]
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No [EUDAMED]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Contains endocrine-disrupting substances: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Measuring function: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Serial number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Precise Bite™ MTCBPBITETDS, Medtec LLC. deviCERTS medical device catalogue. https://devicerts.com/devices/precise-bite-mtcbpbitetds (data as of 2026-11-15).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/precise-bite-mtcbpbitetds.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/precise-bite-mtcbpbitetds
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.