Swerv Magnetostrictive Ultrasonic Scaler System
FDA 510(k) K100401 · Hu-Friedy Mfg. Co., Inc.
510(k) numberK100401
Submission
- Device name
- Swerv Magnetostrictive Ultrasonic Scaler System
- Applicant
- Hu-Friedy Mfg. Co., Inc.
Chicago, IL, US - Received
- February 16, 2010
- Decision date
- March 30, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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| K012060 | Modification To:Hu-Friedy Brand Satin Swivel Ultrasonic InsertELC · Special | 07/27/2001SE |
| K953919 | Dental Ultrasonic Scaler InsertsELC · Traditional | 10/07/1995SE |
| K912473 | Accu-Placer TM KitEKJ · Traditional | 07/24/1991SE |
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Questions and answers
When was Swerv Magnetostrictive Ultrasonic Scaler System cleared by the FDA?
Swerv Magnetostrictive Ultrasonic Scaler System (K100401) received a 510(k) decision of Substantially Equivalent on March 30, 2010, 42 days after the submission was received.
What is the product code of K100401?
The FDA product code is ELC – Scaler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 872.4850.