Submission Details
| 510(k) Number | K033667 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 21, 2003 |
| Decision Date | January 23, 2004 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
Cleared
Traditional
CARRARA PRESS SYSTEM
Jan 2004
Decision
63d
Days
Class 2
Risk
About This 510(k) Submission
K033667 is an FDA 510(k) clearance for the CARRARA PRESS SYSTEM, a Powder, Porcelain (Class II — Special Controls, product code EIH), submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on January 23, 2004, 63 days after receiving the submission on November 21, 2003. 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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