A-Dec/W&H Synea Sonic Scaler Handpiece, Models ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM
FDA 510(k) K100647 · A-Dec, Inc.
510(k) numberK100647
Submission
- Device name
- A-Dec/W&H Synea Sonic Scaler Handpiece, Models ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM
- Applicant
- A-Dec, Inc.
Newberg, OR, US - Received
- March 8, 2010
- Decision date
- July 9, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was A-Dec/W&H Synea Sonic Scaler Handpiece, Models ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM cleared by the FDA?
A-Dec/W&H Synea Sonic Scaler Handpiece, Models ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM (K100647) received a 510(k) decision of Substantially Equivalent on July 9, 2010, 123 days after the submission was received.
What is the product code of K100647?
The FDA product code is ELC – Scaler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 872.4850.