FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70
K Number: K051010
·
Decision May 2, 2005
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
73
Applicant Total
9
Review Days
11
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
- SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70
- K Number
- K051010
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 872.3070
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Septodont
- Date Received
- April 21, 2005
- Decision Date
- May 2, 2005
- Product Code
- EJJ
- 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 |
|---|---|---|---|
| EJJ | Alloy, Amalgam | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EJJ), ordered by most recent decision date.
SILVERFIL
FDA 510(k)
FDA Class 2
·Dental
BESTALOY
FDA 510(k)
FDA Class 2
·Dental
BENCO ADMIX
FDA 510(k)
FDA Class 2
·Dental
BENCO SPHERICAL
FDA 510(k)
FDA Class 2
·Dental
HIGH SILVER CONVENTIONAL
FDA 510(k)
FDA Class 2
·Dental
FUTURA TOPCAP NON GAMMA-2
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Septodont
| K Number | Device Name | ||
|---|---|---|---|
| K212283 | BioRoot Flow 0.5g, BioRoot Flow 2g | Sep 16, 2021 | Substantially Equivalent |
| K211799 | Biodentine XP 500, Biodentine XP 200 | Aug 10, 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 |
| K032708 | PLASTALGIN AND PLASTALGIN ORTHO | Nov 20, 2003 | Substantially Equivalent |