SONICFLEX 2003 AND SONICFLEX LUX 2003 L WITH INSTRUMENT TIPS

Scaler, Ultrasonic

SYBRON DENTAL SPECIALTIES, INC.

The following data is part of a premarket notification filed by Sybron Dental Specialties, Inc. with the FDA for Sonicflex 2003 And Sonicflex Lux 2003 L With Instrument Tips.

Pre-market Notification Details

• Device ID: K080089
• 510k Number: K080089
• Device Name: SONICFLEX 2003 AND SONICFLEX LUX 2003 L WITH INSTRUMENT TIPS
• Classification: Scaler, Ultrasonic
• Applicant: SYBRON DENTAL SPECIALTIES, INC. 1717 W. COLLINS AVE. Orange, CA 92867
• Contact: Colleen Boswell
• Correspondent: Colleen Boswell; SYBRON DENTAL SPECIALTIES, INC. 1717 W. COLLINS AVE. Orange, CA 92867
• Product Code: ELC
• CFR Regulation Number: 872.4850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-01-14
• Decision Date: 2008-09-04
• Summary: summary

NIH GUDID Devices

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