Submission Details
| 510(k) Number | K040859 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 02, 2004 |
| Decision Date | May 20, 2004 |
| Days to Decision | 48 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
Cleared
Traditional
HERACERAM PRESS
May 2004
Decision
48d
Days
Class 2
Risk
About This 510(k) Submission
K040859 is an FDA 510(k) clearance for the HERACERAM PRESS, 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 May 20, 2004, 48 days after receiving the submission on April 2, 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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