FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UltraEZ
K Number: K261404
·
Decision Apr 30, 2026
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
137
Applicant Total
103
Review Days
1
Basic Information
- Device Name
- UltraEZ
- K Number
- K261404
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 872.3260
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ultradent Products, Inc.
- Date Received
- April 29, 2026
- Decision Date
- April 30, 2026
- Product Code
- LBH
- 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 |
|---|---|---|---|
| LBH | Varnish, Cavity | FDA class 2 | Dental |
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