Submission Details
| 510(k) Number | K083059 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 14, 2008 |
| Decision Date | January 30, 2009 |
| Days to Decision | 108 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
Cleared
Traditional
AIR SONIC SCALER
Jan 2009
Decision
108d
Days
Class 2
Risk
About This 510(k) Submission
K083059 is an FDA 510(k) clearance for the AIR SONIC SCALER, a Scaler, Ultrasonic (Class II — Special Controls, product code ELC), submitted by Dpm USA Corp. (Miami, US). The FDA issued a Cleared decision on January 30, 2009, 108 days after receiving the submission on October 14, 2008. This device falls under the Dental review panel. Regulated under 21 CFR 872.4850.
Device Classification
| Product Code | ELC — Scaler, Ultrasonic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 872.4850 |
Manufacturer
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