ULTRASEAL XT PLUS
FDA 510(k) clearance K993846 · decided 2000-02-16
Clearance details
- K-number
- K993846
- Device name
- ULTRASEAL XT PLUS
- Applicant
- Ultradent Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-11-12
- Decision date
- 2000-02-16
- Days to decision
- 96 days
- Clearance type
- Traditional
- Product code
- EBC
- Device class
- 2
- Regulation number
- 872.3765
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- South Jordan, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| UltraSeal XT Plus Clear Refill. The package contains 4x 1.2 ml UltraSeal XT Plus. Product recall (Z-0704-2017) | Ultradent Products, Inc. | 2016-12-03 |