Hydroxylate Dental Composite Restroative
FDA 510(k) K802535 · Wallace A. Erickson & Co.
510(k) numberK802535
Submission
- Device name
- Hydroxylate Dental Composite Restroative
- Applicant
- Wallace A. Erickson & Co.
Mchenry, IL, US - Received
- October 15, 1980
- Decision date
- December 18, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K984503 | Alpha Bond Dentin/Enamel Bonding Agent, Model 213-000KLE · Traditional | 02/26/1999SE |
| K963922 | Alpha-Dent Root Canal Sealer & FillerKIF · Traditional | 12/06/1996SE |
| K960667 | Centrix Flofil/Centrix Flofil with FluorideEBF · Traditional | 07/02/1996SE |
| K960365 | Alpha-Dent Hema DESENTIZER(748-000)/WITH FLUORIDE(747-000)KLE · Traditional | 03/28/1996SE |
| K960165 | Alpha-Dent Composite Surface SealantEBF · Traditional | 03/15/1996SE |
| K960122 | Alpha-Dent Temporary Crown and Bridge MaterialEBG · Traditional | 02/21/1996SE |
| K955521 | Alpha-Dent Copal Cavity VarnishLBH · Traditional | 01/24/1996SE |
| K955089 | Alpha-Dent Zinc Oxide Eugenol Temporary CementEMA · Traditional | 12/13/1995SE |
| K942742 | Alpha Bond-Rite Ii(Tm) or Bond-Rite Ii(Tm) 2-PASTE AdhevDYH · Traditional | 08/29/1994SE |
| K942727 | Alpha Bound-Rite I No-Mix Adhesive or Bond-Rite I No-Mix AdhesiveDYH · Traditional | 08/23/1994SE |
Questions and answers
When was Hydroxylate Dental Composite Restroative cleared by the FDA?
Hydroxylate Dental Composite Restroative (K802535) received a 510(k) decision of Substantially Equivalent on December 18, 1980, 64 days after the submission was received.
What is the product code of K802535?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.