Air Sonic Scaler
by Dpm USA Corp
510(k) K083059
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK083059 | Date30 Jan 2009 | StatusActive |
Official records
- FDA 510(k) database K083059
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ELC
- FDA applicant
- Dpm USA Corp.
- Device class
- Class II
- Regulation
- 21 CFR Part 872.4850
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 25 Sep 2026
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.
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