Submission Details
| 510(k) Number | K990817 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 11, 1999 |
| Decision Date | April 06, 1999 |
| Days to Decision | 26 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
Cleared
Traditional
IPS D.SIGN PORCELAIN
Apr 1999
Decision
26d
Days
Class 2
Risk
About This 510(k) Submission
K990817 is an FDA 510(k) clearance for the IPS D.SIGN PORCELAIN, a Powder, Porcelain (Class II — Special Controls, product code EIH), submitted by Ivoclar North America, Inc. (Amherst, US). The FDA issued a Cleared decision on April 6, 1999, 26 days after receiving the submission on March 11, 1999. 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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