Submission Details
| 510(k) Number | K211916 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 21, 2021 |
| Decision Date | August 20, 2021 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
Cleared
Traditional
IPS e.max One
Aug 2021
Decision
60d
Days
Class 2
Risk
About This 510(k) Submission
K211916 is an FDA 510(k) clearance for the IPS e.max One, a Powder, Porcelain (Class II — Special Controls, product code EIH), submitted by Ivoclar Vivadent, AG (Schaan, LI). The FDA issued a Cleared decision on August 20, 2021, 60 days after receiving the submission on June 21, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.
Device Classification
| Product Code | EIH — Powder, Porcelain |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 872.6660 |
Manufacturer
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