FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ZenSeal Pro
K Number: K252890
·
Decision Jan 7, 2026
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
142
Applicant Total
32
Review Days
118
Basic Information
- Device Name
- ZenSeal Pro
- K Number
- K252890
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3820
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kerr Corporation
- Date Received
- September 11, 2025
- Decision Date
- January 7, 2026
- Product Code
- KIF
- 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 |
|---|---|---|---|
| KIF | Resin, Root Canal Filling | FDA class 2 | Dental |
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Other Clearances by Kerr Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K222830 | Rainbow 360 | Jan 12, 2023 | Substantially Equivalent |
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| K191548 | Nexus Universal Self-Cure | Oct 11, 2019 | Substantially Equivalent |
| K182162 | OptiBond eXTRa Universal | Nov 7, 2018 | Substantially Equivalent |
| K162948 | Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/Materials | Aug 8, 2017 | Substantially Equivalent |
| K163064 | Demi Ultra | Jul 18, 2017 | Substantially Equivalent |
| K162536 | GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord | Feb 3, 2017 | Substantially Equivalent |
| K162164 | GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord | Jan 13, 2017 | Substantially Equivalent |
| K162436 | EndoVac Pure | Dec 21, 2016 | Substantially Equivalent |
| K162257 | P1145 Dental Restorative | Nov 7, 2016 | Substantially Equivalent |