FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇮 Finland
INION BIORESTORE
K Number: K070784
·
Decision Jul 24, 2007
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
229
Applicant Total
14
Review Days
125
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- INION BIORESTORE
- K Number
- K070784
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Inion OY
- Date Received
- March 21, 2007
- Decision Date
- July 24, 2007
- Product Code
- LYC
- 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 |
|---|---|---|---|
| LYC | Bone Grafting Material, Synthetic | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LYC), ordered by most recent decision date.
Bonalive Maxillofacial
FDA 510(k)
FDA Class 2
·Dental
BONTREE PLUS
FDA 510(k)
FDA Class 2
·Dental
FG Bone Graft M
FDA 510(k)
FDA Class 2
·Dental
FG Bone Graft B
FDA 510(k)
FDA Class 2
·Dental
Synthetic Bone Graft Particulate
FDA 510(k)
FDA Class 2
·Dental
CMFlexTM
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Inion OY
| K Number | Device Name | ||
|---|---|---|---|
| K251441 | Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System | Nov 7, 2025 | Substantially Equivalent |
| K251472 | Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System | Jul 11, 2025 | Substantially Equivalent |
| K203105 | Inion CompressOn Screw | Jan 13, 2021 | Substantially Equivalent |
| K191764 | Inion BioRestore | Jul 31, 2019 | Substantially Equivalent |
| K151360 | Inion Spinal Graft Containment System | Oct 6, 2015 | Unknown |
| K133932 | INION FREEDOMPIN | Apr 11, 2014 | Substantially Equivalent |
| K123672 | INION FREEDOMSCREW (ALTERNATIVE MARKETING NAME: INION OTPS FREEDOMSCREW) | Feb 27, 2013 | Substantially Equivalent |
| K122890 | INION CPS ORBITAL PLATES | Jan 29, 2013 | Substantially Equivalent |
| K090177 | INION BIORESTORE BIODEGRADABLE BONE GRAFT SUBSTITUTE | Feb 20, 2009 | Substantially Equivalent |
| K070998 | INION BIORESTORE | Oct 11, 2007 | Substantially Equivalent |