Xeno Adhesive with Activator
FDA 510(k) K051463 · Dentsply Intl.
510(k) numberK051463
Submission
- Device name
- Xeno Adhesive with Activator
- Applicant
- Dentsply Intl.
York, PA, US - Received
- June 3, 2005
- Decision date
- July 12, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Xeno Adhesive with Activator cleared by the FDA?
Xeno Adhesive with Activator (K051463) received a 510(k) decision of Substantially Equivalent on July 12, 2005, 39 days after the submission was received.
What is the product code of K051463?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.