FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Parkell Pit and Fissure Sealant
K Number: K243254
·
Decision Aug 8, 2025
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
130
Applicant Total
53
Review Days
297
Basic Information
- Device Name
- Parkell Pit and Fissure Sealant
- K Number
- K243254
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 872.3765
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Parkell, Inc.
- Date Received
- October 15, 2024
- Decision Date
- August 8, 2025
- 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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|---|---|---|---|
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| K190930 | SmarTemp X1 | Sep 5, 2019 | Substantially Equivalent |
| K182296 | HyperFil-LV | Dec 14, 2018 | Substantially Equivalent |
| K172176 | Parkell Universal Adhesive | Nov 21, 2017 | Substantially Equivalent |
| K151518 | BRUSH&BOND PLUS | Sep 18, 2015 | Substantially Equivalent |
| K142848 | EAZY PRIMER | Feb 24, 2015 | Substantially Equivalent |
| K132115 | ABSOLUTE DENTIN 2 | Jun 25, 2014 | Substantially Equivalent |
| K113839 | RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE | Apr 12, 2012 | Substantially Equivalent |
| K101044 | RETRIEVE IMPLANT CEMENT | Jun 10, 2010 | Substantially Equivalent |