EBF · Material, Tooth Shade, Resin · Chrysalis Intelligence

Device class

Class II

Regulation 872.3690

Total clearances

103

2020-02-25 → 2026-09-21

Last 12 months

Unique sponsors

Classification details

Medical specialty

Dental

Review panel

Regulation number

872.3690

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
DiaDent Group International	5	2	2026-06-02
Voco GmbH	5	1	2026-04-27
Mediclus Co., Ltd.	5	1	2025-12-05
Kulzer, LLC	4	1	2026-03-11
Dentscare Ltda	4	0	2024-10-18
Rizhao Huge Biomaterials Company, Ltd.	4	0	2024-12-20
Aidite (Qinhuangdao) Technology Co., Ltd.	3	1	2026-04-06
Saremco Dental AG	3	0	2024-06-27
GC America, Inc.	3	2	2026-09-10
Ultradent Products, Inc.	3	1	2026-07-01
Spident Co., Ltd.	3	1	2026-09-21
Hangzhou SHINING3D Dental Technology Co., Ltd.	3	2	2026-04-27
Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG	2	0	2023-11-09
Deltamed GmbH	2	0	2024-12-18
Cosmedent, Inc.	2	0	2022-10-11
Tokuyama Dental Corporation	2	0	2021-02-03
Prevest Denpro Limited	2	0	2024-11-27
Premier Dental Products Company	2	1	2025-11-07
Graphy, Inc.	2	0	2023-11-01
Sdi Limited	2	0	2022-10-28
Shofu Dental Corporation	2	0	2025-05-27
Genoss Co., Ltd.	2	0	2020-11-30
Sprintray, Inc.	2	0	2024-10-01
Pac-Dent, Inc.	2	0	2022-05-25
Meta Biomed Co., Ltd.	2	0	2024-10-08

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
D2394	HCPCS	—	Medium	Tooth-shade resin material for restorations, component of composite filling codes

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-09-21	K262982	Spident Co., Ltd.	Core·it Dual
2026-09-10	K262202	GC America, Inc.	Cerasmart Forte
2026-08-31	K261695	Guilin Kevin Peter Technology Co., Ltd.	Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)
2026-07-01	K262228	Ultradent Products, Inc.	Transcend Bulk Fill Flowable Composite
2026-07-01	K261485	Ivoclar Vivadent, Inc.	Tetric plus Fill;Tetric plus Flow
2026-06-18	K261246	GC America, Inc.	SRGC-06
2026-06-02	K261093	DiaDent Group International	DIAFIL
2026-05-19	K261071	DiaDent Group International	DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)
2026-05-11	K260805	Vericom Co., Ltd.	Dual Core
2026-04-27	K261357	Voco GmbH	Grandio disc multicolor
2026-04-27	K261356	Hangzhou SHINING3D Dental Technology Co., Ltd.	Dura-Crown
2026-04-23	K260152	Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda.	Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT)
2026-04-06	K253036	Aidite (Qinhuangdao) Technology Co., Ltd.	Light-curing Coloring Materials (ALCM)
2026-03-11	K260783	Kulzer, LLC	Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One
2026-03-03	K254245	New Stetic, SA	ZAFIRA®
2026-01-21	K260170	Hangzhou SHINING3D Dental Technology Co., Ltd.	LumiCera
2025-12-05	K252465	Mediclus Co., Ltd.	Any-Core
2025-11-07	K253513	Premier Dental Products Company	MultiMatch Flow Chameleon AntiMicrobial Composite
2025-09-29	K253236	Graphenano Dental S.L.	G-BLOCK
2025-09-23	K253053	Hangzhou SHINING3D Dental Technology Co., Ltd.	Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)
2025-08-29	K251946	GC America, Inc.	G aenial Universal Injectable II
2025-06-06	K251283	Mediclus Co., Ltd.	Once-Fil Flow
2025-05-30	K250317	Spident Co., Ltd.	EsFlow PLUS
2025-05-27	K251578	Shofu Dental Corporation	BEAUTIFIL II
2025-05-23	K250778	Dsi Dental Solutions, Ltd.	Sil-Flow