Submission Details
| 510(k) Number | K012231 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 16, 2001 |
| Decision Date | August 23, 2001 |
| Days to Decision | 38 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
Cleared
Traditional
AVANTE MICRO CRYSTAL SYSTEM
Aug 2001
Decision
38d
Days
Class 2
Risk
About This 510(k) Submission
K012231 is an FDA 510(k) clearance for the AVANTE MICRO CRYSTAL SYSTEM, a Powder, Porcelain (Class II — Special Controls, product code EIH), submitted by Jeneric/Pentron, Inc. (Wallingford, US). The FDA issued a Cleared decision on August 23, 2001, 38 days after receiving the submission on July 16, 2001. 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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