Ultrasonic Tooth Scaler Model Dsciop
FDA 510(k) K852540 · Parkell, Inc.
510(k) numberK852540
Submission
- Device name
- Ultrasonic Tooth Scaler Model Dsciop
- Applicant
- Parkell, Inc.
Farmingdale, NY, US - Received
- June 14, 1985
- Decision date
- July 1, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Ultrasonic Tooth Scaler Model Dsciop cleared by the FDA?
Ultrasonic Tooth Scaler Model Dsciop (K852540) received a 510(k) decision of Substantially Equivalent on July 1, 1985, 17 days after the submission was received.
What is the product code of K852540?
The FDA product code is ELC – Scaler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 872.4850.