Cleanse S+ Ultrasonic Scaler

Q: What is the product code of K060171?

The FDA product code is ELC – Scaler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 872.4850.

FDA 510(k) K060171 · Dmetec.Co., Ltd.

Substantially Equivalent

510(k) numberK060171

Submission

Device name: Cleanse S+ Ultrasonic Scaler
Applicant: Dmetec.Co., Ltd.
Great Neck, NY, US
Received: January 23, 2006
Decision date: March 29, 2006
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: ELC – Scaler, Ultrasonic
Device class: Class II (moderate risk)
Regulation: 21 CFR 872.4850
Specialty: Dental

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Questions and answers

When was Cleanse S+ Ultrasonic Scaler cleared by the FDA?

Cleanse S+ Ultrasonic Scaler (K060171) received a 510(k) decision of Substantially Equivalent on March 29, 2006, 65 days after the submission was received.

What is the product code of K060171?

The FDA product code is ELC – Scaler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 872.4850.