Submission Details
| 510(k) Number | K070019 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 03, 2007 |
| Decision Date | January 26, 2007 |
| Days to Decision | 23 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
Cleared
Special
CARRARA VOLUMIA
Jan 2007
Decision
23d
Days
Class 2
Risk
About This 510(k) Submission
K070019 is an FDA 510(k) clearance for the CARRARA VOLUMIA, a Powder, Porcelain (Class II — Special Controls, product code EIH), submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on January 26, 2007, 23 days after receiving the submission on January 3, 2007. 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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