Submission Details
| 510(k) Number | K182118 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 06, 2018 |
| Decision Date | May 03, 2019 |
| Days to Decision | 270 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
Cleared
Traditional
armor LC
May 2019
Decision
270d
Days
Class 1
Risk
About This 510(k) Submission
K182118 is an FDA 510(k) clearance for the armor LC, a Dam, Rubber (Class I — General Controls, product code EIE), submitted by Mavrik Dental Systems, Ltd. (Raanana, IL). The FDA issued a Cleared decision on May 3, 2019, 270 days after receiving the submission on August 6, 2018. This device falls under the Dental review panel. Regulated under 21 CFR 872.6300.
Device Classification
| Product Code | EIE — Dam, Rubber |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 872.6300 |
Manufacturer
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