← Back to catalogue

Vector Ultrasonic Scaler

FDA 510(k)

Class II (US FDA 510(k))

510(k) K002122

by Air Techniques, Inc.

Identifiers

510(k) Number
K002122 FDA 510(k)
FDA Product Code
ELC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.4850 FDA 510(k)
Regulation Number
872.4850 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Vector is an ultrasonic scaler, a dental device designed for the removal of plaque, calculus, and biofilm from teeth and dental restorations. It operates using high-frequency vibrations to disrupt and emulsify hard deposits, facilitating their removal during dental prophylaxis and periodontal therapy. Its ultrasonic action also provides a gentle yet effective cleaning mechanism for subgingival areas, aiding in periodontal health maintenance.

The Vector is supplied as a reusable device, intended for use in dental clinics and private practices. It is classified as a Class II medical device under FDA regulations and has received 510(k) clearance for dental applications. The device requires proper maintenance, including cleaning and sterilization between uses, to ensure safety and efficacy. No specific MRI safety information is provided, and its use must comply with local regulatory and infection control standards.

Frequently asked questions

How is the Vector ultrasonic scaler maintained between patient uses to ensure safety and effectiveness?

The Vector is a reusable device that requires thorough cleaning and sterilization after each use to maintain safety and efficacy. Proper maintenance is essential to prevent cross-contamination and ensure the device operates correctly for dental prophylaxis and periodontal therapy. Follow manufacturer guidelines for disinfection and sterilization protocols to comply with infection control standards.

Is the Vector ultrasonic scaler suitable for use in subgingival areas, and how does its ultrasonic action benefit periodontal health?

Yes, the Vector is specifically designed to clean subgingival areas effectively. Its ultrasonic vibrations disrupt and emulsify hard deposits like plaque and calculus, gently removing them while also aiding in periodontal health maintenance. This makes it ideal for periodontal therapy and thorough dental cleaning.

What regulatory pathway was followed for the Vector’s FDA clearance, and what does this mean for its use in dental practices?

The Vector received FDA clearance through a 510(k) Traditional pathway, demonstrating it is *substantially equivalent* to a legally marketed device in the Dental specialty category. This means it meets FDA standards for safety and effectiveness as an ultrasonic scaler for removing plaque, calculus, and biofilm during dental prophylaxis and periodontal therapy in clinics and private practices.

Are there any specific storage requirements for the Vector ultrasonic scaler to preserve its functionality?

While the provided data does not specify exact storage conditions, reusable medical devices like the Vector should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Proper maintenance, including cleaning and sterilization, is critical—storage should also protect the device from physical damage to ensure longevity and readiness for use.

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 (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Air Techniques, Inc.

Sources (1)

  • FDA 510(k) K002122 24 fields · synced Sep 18, 2026