Nuance
FDA 510(k) K101215 · Discus Dental, LLC
510(k) numberK101215
Submission
- Device name
- Nuance
- Applicant
- Discus Dental, LLC
Culver City, CA, US - Received
- April 30, 2010
- Decision date
- May 12, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
- Third-party review
- Yes
Other 510(k)s with product code EBF
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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 |
|---|---|---|
| K102639 | SL3GEX · Special | 12/01/2010SE |
| K101612 | Zen Cordless Prophy SystemEKX · Traditional | 06/30/2010SE |
| K093208 | SimplisealKIF · Traditional | 02/12/2010SE |
| K092417 | Insight Ultrasonic InsertsELC · Traditional | 12/11/2009SE |
| K073518 | Flashlite Rebel*EBZ · Traditional | 12/20/2007SE |
| K062176 | Relief Acp Oral Care GelLBH · Traditional | 01/10/2007SE |
| K052090 | Splash! Impression Material DeviceELW · Traditional | 08/05/2005SE |
| K051776 | Protege Ultrasonic InsertELC · Traditional | 07/13/2005SE |
| K033785 | Proactive Care Prophylaxis Paste with FluorideEJR · Traditional | 06/18/2004SE |
| K040053 | Precision VPS Impression MaterialELW · Traditional | 03/25/2004SE |
Questions and answers
When was Nuance cleared by the FDA?
Nuance (K101215) received a 510(k) decision of Substantially Equivalent on May 12, 2010, 12 days after the submission was received.
What is the product code of K101215?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.