Beaufill
FDA 510(k) K812545 · Sci-Pharm, Inc.
510(k) numberK812545
Submission
- Device name
- Beaufill
- Applicant
- Sci-Pharm, Inc.
Mchenry, IL, US - Received
- September 4, 1981
- Decision date
- September 25, 1981
- 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 |
|---|---|---|
| K823935 | Micro Join, Crown & Bridge AdhesiveEMA · Traditional | 02/07/1983SE |
| K820092 | Secure-On-TouchDYH · Traditional | 02/24/1982SE |
| K813091 | Fissure Sealer & Bonding AgentEBC · Traditional | 11/24/1981SE |
| K813090 | Composite Dental Restorative MaterialEBF · Traditional | 11/24/1981SE |
| K812550 | BeaucavLBH · Traditional | 09/25/1981SE |
| K812549 | BeausealEBC · Traditional | 09/25/1981SE |
| K812548 | CobeauLBH · Traditional | 09/25/1981SE |
| K812546 | BeaudentEBF · Traditional | 09/25/1981SE |
| K812551 | BeaucorEBF · Traditional | 09/23/1981SE |
| K812547 | BeaubonDYH · Traditional | 09/23/1981SE |
Questions and answers
When was Beaufill cleared by the FDA?
Beaufill (K812545) received a 510(k) decision of Substantially Equivalent on September 25, 1981, 21 days after the submission was received.
What is the product code of K812545?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.