Submission Details
| 510(k) Number | K052543 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 15, 2005 |
| Decision Date | October 25, 2005 |
| Days to Decision | 40 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
Cleared
Traditional
HERACERAM ZIRKONIA
Oct 2005
Decision
40d
Days
Class 2
Risk
About This 510(k) Submission
K052543 is an FDA 510(k) clearance for the HERACERAM ZIRKONIA, a Powder, Porcelain (Class II — Special Controls, product code EIH), submitted by Heraeus Kulzer, Inc. (South Bend, US). The FDA issued a Cleared decision on October 25, 2005, 40 days after receiving the submission on September 15, 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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