Bonasil A+ Impression Materials
FDA 510(k) K102836 · Dmp, Ltd.
510(k) numberK102836
Submission
- Device name
- Bonasil A+ Impression Materials
- Applicant
- Dmp, Ltd.
Markopoulo, GR - Received
- September 29, 2010
- Decision date
- January 13, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Bonasil A+ Impression Materials cleared by the FDA?
Bonasil A+ Impression Materials (K102836) received a 510(k) decision of Substantially Equivalent on January 13, 2011, 106 days after the submission was received.
What is the product code of K102836?
The FDA product code is ELW – Material, Impression, a Class II (moderate risk) device regulated under 21 CFR 872.3660.