Ster-Mate Sterile Lavage Kit
FDA 510(k) K082973 · Dentsply Interntional
510(k) numberK082973
Submission
- Device name
- Ster-Mate Sterile Lavage Kit
- Applicant
- Dentsply Interntional
York, PA, US - Received
- October 6, 2008
- Decision date
- January 29, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Ster-Mate Sterile Lavage Kit cleared by the FDA?
Ster-Mate Sterile Lavage Kit (K082973) received a 510(k) decision of Substantially Equivalent on January 29, 2009, 115 days after the submission was received.
What is the product code of K082973?
The FDA product code is ELC – Scaler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 872.4850.