FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇿 New Zealand
Endoform Dental Membrane
K Number: K231305
·
Decision Jan 23, 2024
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
56
Applicant Total
7
Review Days
263
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Basic Information
- Device Name
- Endoform Dental Membrane
- K Number
- K231305
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aroa Biosurgery , Ltd.
- Date Received
- May 5, 2023
- Decision Date
- January 23, 2024
- 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 Aroa Biosurgery , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K250598 | Endoform Reconstructive Template - PLGA | Jun 3, 2025 | Substantially Equivalent |
| K223373 | Enivo | Apr 7, 2023 | Substantially Equivalent |
| K200502 | Myriad Particles | Mar 31, 2021 | Substantially Equivalent |
| K200413 | Symphony | Jul 29, 2020 | Substantially Equivalent |
| K183398 | Endoform Restella | Apr 11, 2019 | Substantially Equivalent |
| K181935 | Endoform Reconstructive Template - Non Absorbable | Dec 4, 2018 | Substantially Equivalent |