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Dental Chair F1

FDA 510(k)EUDAMED

Class I (US FDA 510(k))

510(k) K884830

by Fimet Oy

Identifiers

510(k) Number
K884830 FDA 510(k)
FDA Product Code
KLC FDA 510(k)

Classification

Device Class
Class I FDA 510(k)
Legislation / Framework
21 CFR Part 872.6250 FDA 510(k)
Regulation Number
872.6250 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Dental Chair F1 is a Chair, Dental, With Operative Unit, designed for patient positioning and support during dental procedures. It integrates an operative unit to facilitate chairside dental treatments, ensuring stability and accessibility for both patients and clinicians.

This device is supplied as a reusable medical instrument, regulated under FDA 510K clearance (K884830), MDD, and MDR compliance. It is intended for use in dental clinics and offices, with multiple model variants (FEI numbers listed) reflecting different configurations or serial ranges. Storage and maintenance should adhere to manufacturer guidelines to preserve functionality and hygiene.

Frequently asked questions

Is the Dental Chair F1 designed for single-use or can it be reused in a clinical setting?

The Dental Chair F1 is explicitly described as a reusable medical instrument. Since it is intended for repeated use in dental clinics, proper cleaning, maintenance, and adherence to manufacturer guidelines are essential to ensure hygiene and functionality. Reuse is supported by its regulatory classification as a Class I device under FDA 510K (K884830) and compliance with MDD/MDR standards.

What are the key model variants or configurations available for the Dental Chair F1, and how can I identify them?

The Dental Chair F1 comes in multiple model variants, each represented by distinct FEI numbers (Federal Equipment Identifier). These include: 3039246551, 3042256511, 3031886796, 3015980207, 3002819275, 3009598746, 3021741513, 3033509587, 3006191485, 3008770655, 3010373494, and 3013237609. These identifiers correspond to different configurations or serial ranges, allowing for customization based on clinic needs. The registration numbers (e.g., 3029780) may also help verify specific variants.

How is the Dental Chair F1 regulated, and what compliance standards does it meet?

The Dental Chair F1 is regulated under FDA 510K clearance (K884830), classified as a Class I device with a Traditional 510(k) pathway. It also complies with the Medical Device Directive (MDD) and Medical Device Regulation (MDR) standards. The device was determined substantially equivalent to a predicate product by the FDA’s Dental (DE) Advisory Committee, ensuring it meets established safety and performance benchmarks for dental chairs with operative units.

What should I consider when storing or maintaining the Dental Chair F1 to ensure longevity and hygiene?

Since the Dental Chair F1 is reusable, storage and maintenance are critical to preserve functionality and hygiene. The manufacturer’s guidelines (not provided here) should be followed for cleaning, disinfection, and periodic inspections. Proper storage—such as in a dry, climate-controlled environment—helps prevent wear and tear. Regular maintenance checks are recommended to ensure stability, accessibility, and compliance with clinical standards, especially given its use in dental procedures requiring precision and reliability.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Fimet Oy

Sources (2)

  • FDA 510(k) K884830 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026