Submission Details
| 510(k) Number | K152274 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 12, 2015 |
| Decision Date | March 25, 2016 |
| Days to Decision | 226 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
Cleared
Traditional
MSCB-001
Mar 2016
Decision
226d
Days
Class 2
Risk
About This 510(k) Submission
K152274 is an FDA 510(k) clearance for the MSCB-001, a Powder, Porcelain (Class II — Special Controls, product code EIH), submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on March 25, 2016, 226 days after receiving the submission on August 12, 2015. 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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