FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
Biodentine XP 500, Biodentine XP 200
K Number: K211799
·
Decision Aug 10, 2021
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
142
Applicant Total
9
Review Days
61
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Basic Information
- Device Name
- Biodentine XP 500, Biodentine XP 200
- K Number
- K211799
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3820
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Septodont
- Date Received
- June 10, 2021
- Decision Date
- August 10, 2021
- Product Code
- KIF
- 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 |
|---|---|---|---|
| KIF | Resin, Root Canal Filling | FDA class 2 | Dental |
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Other Clearances by Septodont
| K Number | Device Name | ||
|---|---|---|---|
| K212283 | BioRoot Flow 0.5g, BioRoot Flow 2g | Sep 16, 2021 | Substantially Equivalent |
| K172839 | ENDOSOLV | Feb 13, 2018 | Substantially Equivalent |
| K140132 | BIODENTINE | Jun 27, 2014 | Substantially Equivalent |
| K093711 | RACEGEL | Feb 17, 2010 | Substantially Equivalent |
| K092251 | BIODENTINE | Oct 30, 2009 | Substantially Equivalent |
| K063634 | RTR SYRINGE | May 11, 2007 | Substantially Equivalent |
| K051010 | SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70 | May 2, 2005 | Substantially Equivalent |
| K032708 | PLASTALGIN AND PLASTALGIN ORTHO | Nov 20, 2003 | Substantially Equivalent |