Submission Details
| 510(k) Number | K080089 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 14, 2008 |
| Decision Date | September 04, 2008 |
| Days to Decision | 234 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
Cleared
Traditional
SONICFLEX 2003 AND SONICFLEX LUX 2003 L WITH INSTRUMENT TIPS
Sep 2008
Decision
234d
Days
Class 2
Risk
About This 510(k) Submission
K080089 is an FDA 510(k) clearance for the SONICFLEX 2003 AND SONICFLEX LUX 2003 L WITH INSTRUMENT TIPS, a Scaler, Ultrasonic (Class II — Special Controls, product code ELC), submitted by Sybron Dental Specialties, Inc. (Orange, US). The FDA issued a Cleared decision on September 4, 2008, 234 days after receiving the submission on January 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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