FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FUTURA TOPCAP NON GAMMA-2
K Number: K011801
·
Decision Aug 16, 2001
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
73
Applicant Total
13
Review Days
69
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Basic Information
- Device Name
- FUTURA TOPCAP NON GAMMA-2
- K Number
- K011801
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3070
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ab Ardent
- Date Received
- June 8, 2001
- Decision Date
- August 16, 2001
- 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 |
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Other Clearances by Ab Ardent
| K Number | Device Name | ||
|---|---|---|---|
| K131753 | MERIDIAN | Nov 14, 2013 | Substantially Equivalent |
| 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 |
| K991974 | FUTURA GLASS IONOMER SILVER REINFORCED | Sep 17, 1999 | Substantially Equivalent |
| K982458 | VIVALLOY HR | Aug 24, 1998 | Substantially Equivalent |