CHALLENGE-EVER— 510(k) K102223
Substantially EquivalentHallim Dentech Co., Ltd.
FDA 510(k) clearance K102223 for CHALLENGE-EVER, Substantially Equivalent on 2011-02-25. Applicant: Hallim Dentech Co., Ltd.. Device class: 1.
Clearance details
- Applicant
- Hallim Dentech Co., Ltd.
- Product code
- Code EIA
- Device class
- Class 1
- Regulation
- 21 CFR 872.6640
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fullerton, CA, US
Recent devices under product code EIA
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