Submission Details
| 510(k) Number | K070772 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 21, 2007 |
| Decision Date | April 30, 2007 |
| Days to Decision | 40 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
Cleared
Traditional
PRESSX ZR
Apr 2007
Decision
40d
Days
Class 2
Risk
About This 510(k) Submission
K070772 is an FDA 510(k) clearance for the PRESSX ZR, a Powder, Porcelain (Class II — Special Controls, product code EIH), submitted by Wieland Dental + Technik GmbH & Co. KG (Pforzheim, DE). The FDA issued a Cleared decision on April 30, 2007, 40 days after receiving the submission on March 21, 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 |
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