Submission Details
| 510(k) Number | K051462 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 03, 2005 |
| Decision Date | June 24, 2005 |
| Days to Decision | 21 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
Cleared
Special
MODIFICATION TO: CERCON BASE
Jun 2005
Decision
21d
Days
Class 2
Risk
About This 510(k) Submission
K051462 is an FDA 510(k) clearance for the MODIFICATION TO: CERCON BASE, a Powder, Porcelain (Class II — Special Controls, product code EIH), submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on June 24, 2005, 21 days after receiving the submission on June 3, 2005. 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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