FORMA Composite (Shade A3D)
FDA 510(k) K240694 · Ultradent Products, Inc.
510(k) numberK240694
Submission
- Device name
- FORMA Composite (Shade A3D)
- Applicant
- Ultradent Products, Inc.
South Jordan, UT, US - Received
- March 14, 2024
- Decision date
- March 15, 2024
- 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 |
|---|---|---|
| K262228 | Transcend Bulk Fill Flowable CompositeEBF · Traditional | 07/01/2026SE |
| K261404 | UltraEZLBH · Special | 04/30/2026SE |
| K240743 | Peak Universal BondKLE · Special | 03/20/2024SE |
| K221909 | J-TempEBF · Traditional | 07/01/2022SE |
| K220471 | VALO X, VALO X Accessory LensesEBZ · Traditional | 02/22/2022SE |
| K211905 | UltraCal XSKIF · Traditional | 10/13/2021SE |
| K211237 | UltraTemp Rez IIEMA · Traditional | 07/13/2021SE |
| K210550 | VALO Grand Corded and Accessory LensesEBZ · Traditional | 03/01/2021SE |
| K190627 | VALO Grand CordedEBZ · Special | 04/29/2019SE |
| K173163 | ChlorCid, ChlorCid V, ChlorCid SurfKJJ · Traditional | 02/09/2018SE |
Questions and answers
When was FORMA Composite (Shade A3D) cleared by the FDA?
FORMA Composite (Shade A3D) (K240694) received a 510(k) decision of Substantially Equivalent on March 15, 2024, 1 days after the submission was received.
What is the product code of K240694?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.