UltraEZ
FDA 510(k) clearance K261404 · decided 2026-04-30
Clearance details
- K-number
- K261404
- Device name
- UltraEZ
- Applicant
- Ultradent Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2026-04-29
- Decision date
- 2026-04-30
- Days to decision
- 1 days
- Clearance type
- Special
- Product code
- LBH
- Device class
- 2
- Regulation number
- 872.3260
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- South Jordan, UT, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.