Renamel Bulkfill
FDA 510(k) K211259 · Cosmedent, Inc.
510(k) numberK211259
Submission
- Device name
- Renamel Bulkfill
- Applicant
- Cosmedent, Inc.
Chicago, IL, US - Received
- April 26, 2021
- Decision date
- June 24, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code EBF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K240714 | Insure® Universal; Insure® Universal AutomixEMA · Traditional | 07/24/2024SE |
| K222435 | Renamel® Microhybrid ;Renamel® Flowable MicrohybridEBF · Traditional | 10/11/2022SE |
| K172707 | Renamel MicrofillEBF · Traditional | 12/05/2017SE |
| K163480 | Renamel NANO +plusEBF · Traditional | 02/24/2017SE |
| K092730 | Cosmedent Brushable CompositeEBF · Traditional | 11/20/2009SE |
| K070583 | Nano CompositeEBF · Traditional | 04/16/2007SE |
| K060881 | Temporary Crown & Bridge ResinEBG · Traditional | 05/16/2006SE |
| K052263 | Multiple (Tooth Desensitizer)LBH · Traditional | 12/16/2005SE |
| K052501 | Multiple Resin Tooth Bonding AgentKLE · Traditional | 10/21/2005SE |
| K042823 | Cosmedent Pit & Fissure SealantEBC · Traditional | 12/01/2004SE |
Questions and answers
When was Renamel Bulkfill cleared by the FDA?
Renamel Bulkfill (K211259) received a 510(k) decision of Substantially Equivalent on June 24, 2021, 59 days after the submission was received.
What is the product code of K211259?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.