FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
THE Graft Collagen
K Number: K230305
·
Decision Jul 24, 2024
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
39
Applicant Total
6
Review Days
537
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Basic Information
- Device Name
- THE Graft Collagen
- K Number
- K230305
- 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
- February 3, 2023
- Decision Date
- July 24, 2024
- Product Code
- NPM
- 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 |
|---|---|---|---|
| NPM | Bone Grafting Material, Animal Source | FDA class 2 | Dental |
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Other Clearances by Purgo Biologics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K230091 | THE Cover | Oct 6, 2023 | 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 |