Submission Details
| 510(k) Number | K043247 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 23, 2004 |
| Decision Date | December 22, 2004 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
Cleared
Traditional
DUCERA ALLCERAM
Dec 2004
Decision
29d
Days
Class 2
Risk
About This 510(k) Submission
K043247 is an FDA 510(k) clearance for the DUCERA ALLCERAM, a Powder, Porcelain (Class II — Special Controls, product code EIH), submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on December 22, 2004, 29 days after receiving the submission on November 23, 2004. 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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