Transcend
FDA 510(k) clearance K201795 · decided 2020-09-28
Clearance details
- K-number
- K201795
- Device name
- Transcend
- Applicant
- Ultradent Product, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-06-30
- Decision date
- 2020-09-28
- Days to decision
- 90 days
- Clearance type
- Abbreviated
- Product code
- EBF
- Device class
- 2
- Regulation number
- 872.3690
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- South Jordan, UT, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Tetric plus Fill;Tetric plus Flow (K261485) | Ivoclar Vivadent, Inc. | 2026-07-01 |
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| Dual Core (K260805) | Vericom Co., Ltd. | 2026-05-11 |
| Grandio disc multicolor (K261357) | Voco GmbH | 2026-04-27 |
| Dura-Crown (K261356) | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2026-04-27 |
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| Midas Restore (K260661) | Sprintray, Inc. | 2026-04-15 |
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| Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One (K260783) | Kulzer, LLC | 2026-03-11 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brand Name: Transcend Product Name: Transcend Econo Kit (UB) - Singles Model/Catalog Numbe recall (Z-3067-2024) | Ultradent Products, Inc. | 2024-09-06 |
| Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Refill 10pk Mode recall (Z-3068-2024) | Ultradent Products, Inc. | 2024-09-06 |