Air Sonic Scaler
FDA 510(k)Class II (US FDA 510(k))
by Dpm Usa Corp
Identifiers
- 510(k) Number
- K083059 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)
An ultrasonic scaler is a dental device used for cleaning and periodontal therapy. The Air Sonic Scaler utilizes air pressure to drive an ultrasonically vibrating tip at 6,000 Hz to remove calculus, tartar, and stains from teeth through mechanical vibration.
It is supplied with interchangeable tips in three shapes (AS1, AS2, AS3) constructed of 440A stainless steel. The device is used by dental professionals in clinical settings and is authorized under FDA 510(k) clearance K083059.
Frequently asked questions
What is the Air Sonic Scaler used for?
The Air Sonic Scaler is used for cleaning and periodontal therapy, specifically to remove calculus, tartar, and stains from teeth through mechanical vibration of its ultrasonically driven tip.
How is the Air Sonic Scaler powered and what frequency does it operate at?
The device utilizes air pressure to drive an ultrasonically vibrating tip, operating at a frequency of 6,000 Hz to achieve effective calculus and stain removal.
What types of tips are included with the Air Sonic Scaler and what are they made of?
The Air Sonic Scaler is supplied with interchangeable tips in three shapes (AS1, AS2, AS3), all constructed of 440A stainless steel for durability and corrosion resistance.
Who is intended to use the Air Sonic Scaler and in what setting?
The device is intended for use by dental professionals in clinical settings, such as dental offices or clinics, for performing ultrasonic scaling procedures.
What regulatory authorization does the Air Sonic Scaler have?
The Air Sonic Scaler is authorized under FDA 510(k) clearance K083059, indicating it is substantially equivalent to a legally marketed predicate device.
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. Sources consulted: AIR SONIC SCALER (K083059) — FDA 510 (k) | Innolitics, fda.innolitics.com, Dpm Usa Corp in Miami - Supplier of Air Scaler & Amalgamator
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K083059 | Class II | Active |
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Manufacturer
- Manufacturer
- Dpm Usa Corp
- FDA Applicant
- Dpm USA Corp.
Sources (1)
- FDA 510(k) K083059 24 fields · synced Sep 25, 2026