FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MERIDIAN
K Number: K131753
·
Decision Nov 14, 2013
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
931
Applicant Total
13
Review Days
153
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
- MERIDIAN
- K Number
- K131753
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ab Ardent
- Date Received
- June 14, 2013
- Decision Date
- November 14, 2013
- Product Code
- EBF
- 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 |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EBF), ordered by most recent decision date.
SRGC-06
FDA 510(k)
FDA Class 2
·Dental
DIAFIL
FDA 510(k)
FDA Class 2
·Dental
DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)
FDA 510(k)
FDA Class 2
·Dental
Dual Core
FDA 510(k)
FDA Class 2
·Dental
Dura-Crown
FDA 510(k)
FDA Class 2
·Dental
Grandio disc multicolor
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Ab Ardent
| K Number | Device Name | ||
|---|---|---|---|
| K040465 | LATIT FLOW | Jul 20, 2004 | Substantially Equivalent |
| K022971 | MICROHYBRID 11 | Nov 25, 2002 | Substantially Equivalent |
| K022973 | ADHESIVE 14 | Nov 22, 2002 | Substantially Equivalent |
| K022972 | MICROFILL 13 | Nov 22, 2002 | Substantially Equivalent |
| K022974 | MICROHYBRID 12 | Nov 22, 2002 | Substantially Equivalent |
| K022975 | ETCHING 15 | Nov 22, 2002 | Substantially Equivalent |
| K020452 | HIGH SILVER CONVENTIONAL | May 7, 2002 | Substantially Equivalent |
| K011801 | FUTURA TOPCAP NON GAMMA-2 | Aug 16, 2001 | Substantially Equivalent |
| K991974 | FUTURA GLASS IONOMER SILVER REINFORCED | Sep 17, 1999 | Substantially Equivalent |
| K982458 | VIVALLOY HR | Aug 24, 1998 | Substantially Equivalent |