FREEPRINT crown
FDA 510(k) K222877 · Detax GmbH
510(k) numberK222877
Submission
- Device name
- FREEPRINT crown
- Applicant
- Detax GmbH
Ettingen, DE - Received
- September 22, 2022
- Decision date
- September 23, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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|---|---|---|---|
| K262202 | Cerasmart ForteEBF · Traditional | GC America, Inc. | 09/10/2026SE |
| K261695 | Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)EBF · Traditional | Guilin Kevin Peter Technology Co., Ltd. | 08/31/2026SE |
| K262228 | Transcend Bulk Fill Flowable CompositeEBF · Traditional | Ultradent Products, Inc. | 07/01/2026SE |
| K261485 | Tetric plus Fill;Tetric plus FlowEBF · Traditional | Ivoclar Vivadent, Inc. | 07/01/2026SE |
| K261246 | SRGC-06EBF · Traditional | GC America, Inc. | 06/18/2026SE |
| K261093 | DiafilEBF · Traditional | DiaDent Group International | 06/02/2026SE |
| K261071 | DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW…EBF · Traditional | DiaDent Group International | 05/19/2026SE |
| K260805 | Dual CoreEBF · Traditional | Vericom Co., Ltd. | 05/11/2026SE |
| K261357 | Grandio disc multicolorEBF · Traditional | Voco GmbH | 04/27/2026SE |
| K261356 | Dura-CrownEBF · Special | Hangzhou SHINING3D Dental Technology Co., Ltd. | 04/27/2026SE |
More from Hangzhou SHINING3D Dental Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K252430 | Freeprint® denture flexEBI · Traditional | 10/30/2025SE |
| K232448 | FREEPRINT® splintmasterMQC · Traditional | 10/12/2023SE |
| K200461 | Freeprint dentureEBI · Traditional | 11/16/2020SE |
| K200273 | FREEPRINT tempEBG · Traditional | 10/27/2020SE |
| K162654 | mollosil plusEBI · Traditional | 03/13/2017SE |
| K100247 | Detax Implantlink SemiEMA · Traditional | 07/23/2010SE |
| K994012 | Tempofit, Model 02693EBG · Traditional | 02/16/2000SE |
Questions and answers
When was FREEPRINT crown cleared by the FDA?
FREEPRINT crown (K222877) received a 510(k) decision of Substantially Equivalent on September 23, 2022, 1 days after the submission was received.
What is the product code of K222877?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.