Submission Details
| 510(k) Number | K151894 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 10, 2015 |
| Decision Date | October 29, 2015 |
| Days to Decision | 111 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
Cleared
Traditional
IPS Ivocolor
Oct 2015
Decision
111d
Days
Class 2
Risk
About This 510(k) Submission
K151894 is an FDA 510(k) clearance for the IPS Ivocolor, a Powder, Porcelain (Class II — Special Controls, product code EIH), submitted by Ivoclar Vivadent, AG (Schaan, LI). The FDA issued a Cleared decision on October 29, 2015, 111 days after receiving the submission on July 10, 2015. 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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