Prolink Adhesives (Prolink, Prolink Se)
FDA 510(k) K110403 · Silmet , Ltd.
510(k) numberK110403
Submission
- Device name
- Prolink Adhesives (Prolink, Prolink Se)
- Applicant
- Silmet , Ltd.
Or Yehuda, IL - Received
- February 11, 2011
- Decision date
- September 8, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Prolink Adhesives (Prolink, Prolink Se) cleared by the FDA?
Prolink Adhesives (Prolink, Prolink Se) (K110403) received a 510(k) decision of Substantially Equivalent on September 8, 2011, 209 days after the submission was received.
What is the product code of K110403?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.