FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AEGIS PIT & FISSURE SEALANT WITH ACP
K Number: K033751
·
Decision Feb 5, 2004
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
130
Applicant Total
45
Review Days
66
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Basic Information
- Device Name
- AEGIS PIT & FISSURE SEALANT WITH ACP
- K Number
- K033751
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3765
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Harry J. Bosworth Co.
- Date Received
- December 1, 2003
- Decision Date
- February 5, 2004
- Product Code
- EBC
- 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 |
|---|---|---|---|
| EBC | Sealant, Pit And Fissure, And Conditioner | FDA class 2 | Dental |
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Other Clearances by Harry J. Bosworth Co.
| K Number | Device Name | ||
|---|---|---|---|
| K103585 | BOSWORTH AEGIS LINER & RESTORATIVE MATERIAL W/ACP | Mar 4, 2011 | Substantially Equivalent |
| K100731 | BOSWORTH AIR POLISHER | Dec 3, 2010 | Substantially Equivalent |
| K061611 | BOSWORTH DENTIN RESIN | Sep 11, 2006 | Substantially Equivalent |
| K051224 | BOSWORTH SEAL | Jul 28, 2005 | Substantially Equivalent |
| K043170 | BOSWORTH BOND | Feb 25, 2005 | Substantially Equivalent |
| K040548 | AEGIS ORTHO LIGHT-CURED ORTHODONTIC ADHESIVE | Mar 19, 2004 | Substantially Equivalent |
| K040547 | AEGIS ORTHO DUAL-CURED ORTHODONTIC ADHESIVE | Mar 19, 2004 | Substantially Equivalent |
| K031439 | ALGINATE IMPRESSION MATERIAL III (FAST & REGULAR) | Oct 2, 2003 | Substantially Equivalent |
| K031811 | PIT & FISSURE SEALANT WITH FLUORIDE | Sep 4, 2003 | Substantially Equivalent |
| K994027 | ACTIVATOR PASTE | Apr 13, 2000 | Substantially Equivalent |