Hyflex Heavy, Hyflex Mono, Hyflex Light— 510(k) K151262
Substantially EquivalentOsstem Implant Co., Ltd.
FDA 510(k) clearance K151262 for Hyflex Heavy, Hyflex Mono, Hyflex Light, Substantially Equivalent on 2015-09-21. Applicant: Osstem Implant Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Osstem Implant Co., Ltd.
- Product code
- Code ELW
- Device class
- Class 2
- Regulation
- 21 CFR 872.3660
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Busan, KR
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More clearances from Osstem Implant Co., Ltd.
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