FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PACSEAL PIT & FISSURE SEALANT
K Number: K141717
·
Decision Mar 9, 2015
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
130
Applicant Total
9
Review Days
257
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Basic Information
- Device Name
- PACSEAL PIT & FISSURE SEALANT
- K Number
- K141717
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3765
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pac-Dent International, Inc.
- Date Received
- June 25, 2014
- Decision Date
- March 9, 2015
- 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 Pac-Dent International, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K162662 | GingiDent Gingival Retraction Paste | Oct 20, 2017 | Substantially Equivalent |
| K160577 | PacEndo Chlorhexidine | Jul 25, 2016 | Substantially Equivalent |
| K151123 | Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film | Mar 3, 2016 | Substantially Equivalent |
| K153528 | PacEndo EDTA | Feb 1, 2016 | Substantially Equivalent |
| K151852 | PacEndo Sodium Hyprochlorite | Nov 10, 2015 | Substantially Equivalent |
| K151150 | Elements | Jul 28, 2015 | Substantially Equivalent |
| K141422 | PROFLUORO FLUORIDE VARNISH | Sep 30, 2014 | Substantially Equivalent |
| K130672 | OPTIFLOW II FLOWABLE COMPOSITE, LC | Aug 13, 2013 | Substantially Equivalent |