Lava Ultimate Cad/Cam Restorative for Cerec / E4D, Lava Ultimate Implant Crown Restorative
FDA 510(k) K110131 · 3M Espe Dental Products
510(k) numberK110131
Submission
- Device name
- Lava Ultimate Cad/Cam Restorative for Cerec / E4D, Lava Ultimate Implant Crown Restorative
- Applicant
- 3M Espe Dental Products
St. Paul, MN, US - Received
- January 18, 2011
- Decision date
- January 21, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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Questions and answers
When was Lava Ultimate Cad/Cam Restorative for Cerec / E4D, Lava Ultimate Implant Crown Restorative cleared by the FDA?
Lava Ultimate Cad/Cam Restorative for Cerec / E4D, Lava Ultimate Implant Crown Restorative (K110131) received a 510(k) decision of Substantially Equivalent on January 21, 2011, 3 days after the submission was received.
What is the product code of K110131?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.