SEEK Caries Detection Device

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Seek

Generic Name

Dental caries detector, optical induced fluorescence

Device Name

Seek & Sable Seek

Model / Ref / Catalog

1804

Primary DI / UDI-DI

00883205103116

Basic UDI-DI

0883205-TF012AJ

510(k) Number

K953526 ↗

FDA Product Code

LFC 510(k)

EBF GUDID

EMDN Code

Q010199 Conservative dentistry and endodontics devices - other

GMDN Term

Dental caries detector, optical induced fluorescence

Device Class

Class IIa EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 872.1740 510(k)

872.3690 GUDID

EU market of registration

Germany

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

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• How does the SEEK device help detect dental caries that might be missed by standard visual or X-ray exams?

  The SEEK device uses advanced diagnostic technology to detect early-stage dental caries by identifying demineralization in tooth enamel. Unlike conventional visual or radiographic methods, it can pinpoint sub-surface lesions that may not be visible through standard examinations, enabling earlier and more precise caries detection.

• Is the SEEK device single-use or reusable, and what does that mean for my practice’s workflow?

  The SEEK is designed as a reusable diagnostic instrument, meaning it can be used multiple times without requiring sterilization between patients. This is because it is intended for direct application to teeth without patient contact, simplifying workflow and reducing processing time compared to single-use devices.

• What regulatory pathways does the SEEK follow, and how does that affect its use in dental offices?

  The SEEK is cleared under the FDA’s 510(k) pathway as a Class II medical device, with a product code of LFC (Dental Caries Detection Devices). It also complies with EU MDR requirements, ensuring it meets both U.S. and European regulatory standards for caries detection devices. This classification confirms its safety and effectiveness for use in dental offices and clinics.

• Are there different sizes or models of the SEEK device, and how do I determine which one to use?

  The SEEK device is supplied as a single reusable diagnostic instrument, with no mention of multiple sizes or models in the provided data. It is designed for general use in dental offices and clinics, so no additional selection is required beyond ensuring compatibility with your practice’s workflow.