FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Hyflex Heavy, Hyflex Mono, Hyflex Light
K Number: K151262
·
Decision Sep 21, 2015
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
401
Applicant Total
68
Review Days
131
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Basic Information
- Device Name
- Hyflex Heavy, Hyflex Mono, Hyflex Light
- K Number
- K151262
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Osstem Implant Co., Ltd.
- Date Received
- May 13, 2015
- Decision Date
- September 21, 2015
- Product Code
- ELW
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ELW | Material, Impression | FDA class 2 | Dental |
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