FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
THE Cover
K Number: K230091
·
Decision Oct 6, 2023
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
56
Applicant Total
6
Review Days
267
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Basic Information
- Device Name
- THE Cover
- K Number
- K230091
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Purgo Biologics, Inc.
- Date Received
- January 12, 2023
- Decision Date
- October 6, 2023
- Product Code
- NPL
- 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 |
|---|---|---|---|
| NPL | Barrier, Animal Source, Intraoral | FDA class 2 | Dental |
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Other Clearances by Purgo Biologics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K230305 | THE Graft Collagen | Jul 24, 2024 | Substantially Equivalent |
| K222549 | OpenTex | May 11, 2023 | Substantially Equivalent |
| K191737 | The Graft Bone Substitute | Feb 14, 2020 | Substantially Equivalent |
| K180992 | Biotex | Jul 16, 2019 | Substantially Equivalent |
| K173188 | The Graft Natural Bone Substitute | Jul 20, 2018 | Substantially Equivalent |