Transcend
Material, Tooth Shade, Resin
Ultradent Product, Inc.
The following data is part of a premarket notification filed by Ultradent Product, Inc. with the FDA for Transcend.
Pre-market Notification Details
| Device ID | K201795 |
| 510k Number | K201795 |
| Device Name: | Transcend |
| Classification | Material, Tooth Shade, Resin |
| Applicant | Ultradent Product, Inc. 505 West Ultradent Drive (10200 South) South Jordan, UT 84095 |
| Contact | Karen Kakunes |
| Correspondent | Karen Kakunes Ultradent Product, Inc. 505 West Ultradent Drive (10200 South) South Jordan, UT 84095 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-30 |
| Decision Date | 2020-09-28 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00883205033680 | K201795 | 000 |
| 00883205028150 | K201795 | 000 |
| 00883205028143 | K201795 | 000 |
| 00883205028136 | K201795 | 000 |
| 00883205028129 | K201795 | 000 |
| 00883205028112 | K201795 | 000 |
| 00883205028105 | K201795 | 000 |
| 00883205028099 | K201795 | 000 |
| 00883205023919 | K201795 | 000 |
| 00883205028167 | K201795 | 000 |
| 00883205028259 | K201795 | 000 |
| 00883205028433 | K201795 | 000 |
| 00883205028334 | K201795 | 000 |
| 00883205028327 | K201795 | 000 |
| 00883205028310 | K201795 | 000 |
| 00883205028303 | K201795 | 000 |
| 00883205028297 | K201795 | 000 |
| 00883205028280 | K201795 | 000 |
| 00883205028273 | K201795 | 000 |
| 00883205023902 | K201795 | 000 |
Trademark Results [Transcend]
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