Submission Details
| 510(k) Number | K152247 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 10, 2015 |
| Decision Date | January 29, 2016 |
| Days to Decision | 172 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
Cleared
Traditional
ATLANTIS Crown
Jan 2016
Decision
172d
Days
Class 2
Risk
About This 510(k) Submission
K152247 is an FDA 510(k) clearance for the ATLANTIS Crown, a Powder, Porcelain (Class II — Special Controls, product code EIH), submitted by Dentsply International, Inc. (York, US). The FDA issued a Cleared decision on January 29, 2016, 172 days after receiving the submission on August 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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