# Tempofit, Model 02693

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

- Canonical page: <https://devicerts.com/devices/tempofit-model-02693-ebg>
- Manufacturer: [DETAX GmbH & Co. KG](https://devicerts.com/manufacturers/detax-gmbh-and-co-kg) (Germany)
- Name in the registry: TEMPOFIT, MODEL 02693
- Device class: Class II (US FDA)
- FDA product code: EBG

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K994012 · decision 2000-02-16 · decision SESE · status: Active

## Recalls

No recall on record.

## Identifiers

- 510(k) Number: K994012 [FDA 510(k)]
- FDA product code: EBG [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 872.3770 [FDA 510(k)]
- Advisory committee: Dental [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: Tempofit, Model 02693, DETAX GmbH & Co. KG. deviCERTS medical device catalogue. https://devicerts.com/devices/tempofit-model-02693-ebg (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/tempofit-model-02693-ebg.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/tempofit-model-02693-ebg
- 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.