FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio
K Number: K232498
·
Decision Aug 18, 2023
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
130
Applicant Total
2
Review Days
1
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio
- K Number
- K232498
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3765
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ultradent Product, Inc.
- Date Received
- August 17, 2023
- Decision Date
- August 18, 2023
- Product Code
- EBC
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- Y
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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EBC), ordered by most recent decision date.
Any-Com Seal
FDA 510(k)
FDA Class 2
·Dental
Parkell Pit and Fissure Sealant
FDA 510(k)
FDA Class 2
·Dental
Enamel Coating Resin
FDA 510(k)
FDA Class 2
·Dental
BA Pit & Fissure Sealant
FDA 510(k)
FDA Class 2
·Dental
Helioseal F Plus
FDA 510(k)
FDA Class 2
·Dental
Pulpdent (Activa) Pit and Fissure Sealant with MCP
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Ultradent Product, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K201795 | Transcend | Sep 28, 2020 | Substantially Equivalent |