EIH · Powder, Porcelain · Chrysalis Intelligence

Device class

Class II

Regulation 872.6660

Total clearances

113

2020-01-15 → 2026-07-30

Last 12 months

Unique sponsors

Classification details

Medical specialty

Dental

Review panel

Regulation number

872.6660

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
Prismatik Dentalcraft, Inc.	13	3	2026-07-30
Aidite (Qinhuangdao) Technology Co., Ltd.	8	0	2025-05-20
Vatech Acucera, Inc.	4	0	2022-10-06
Kuraray Noritake Dental, Inc.	4	0	2025-05-29
Shenzhen Yurucheng Dental Materials Co., Ltd.	3	0	2023-12-21
Dentsply Sirona	3	0	2024-10-24
Shenzhen Xiangtong Co., Ltd.	3	1	2025-12-08
Whitepeaks Dental Solutions GmbH	3	0	2024-09-18
Yilink (Tianjin) Biotechnology Co., Ltd.	3	0	2024-10-10
Chengdu Besmile Medical Technology Co., Ltd.	3	0	2024-03-19
Genoss Co., Ltd.	2	0	2024-06-21
United Dental Resources Corporation	2	0	2021-02-23
Bloomden Bioceramics (HuNan) Co., Ltd.	2	1	2026-03-30
Vita Zahnfabrik GmbH H Rauter & CO	2	0	2020-07-21
Dongguan Xiangtong Co., Ltd.	2	0	2022-06-29
Hass Corp.	2	1	2026-06-11
Dental Direkt GmbH	2	0	2024-09-06
Hunan Qinghao Puzhong Technology Co., Ltd.	2	1	2026-07-17
Liaoning Upcera Co., Ltd.	2	1	2026-01-09
Osstem Implant Co., Ltd.	2	0	2024-11-20
Hunan Vsmile Biotechnology Co., Ltd.	2	0	2024-11-13
Dentalmax Co., Ltd.	2	0	2024-09-30
Arum Dentistry Co., Ltd.	2	0	2025-07-10
Ivoclar Vivadent, AG	2	1	2026-03-10
Argen Corporation	1	0	2024-10-24

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
D5420	CPT	—	Medium	Denture porcelain tooth replacement; context-dependent on clinical use
D5980	CPT	—	Medium	Porcelain/ceramic materials for denture or prosthetic fabrication

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-07-30	K262239	Prismatik Dentalcraft, Inc.	Obsidian® Press Over Zirconia
2026-07-17	K261046	Hunan Qinghao Puzhong Technology Co., Ltd.	Dental Zirconia Blank & Coloring Liquid
2026-06-30	K262195	Zima International Inc., dba Dandy	Dandy Ceramic Stain and Glaze
2026-06-29	K260918	Amann Girrbach AG	Zolid Lunaris
2026-06-11	K260859	Hass Corp.	Rosetta SM, Rosetta SP
2026-05-21	K253191	Dental Creativ Management GmbH	DCMhotbond zircon
2026-04-09	K260067	Shandong Huge Dental Material Corporation	Eternal Art Porcelain Powders
2026-03-30	K260370	Bloomden Bioceramics (HuNan) Co., Ltd.	Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
2026-03-10	K253953	Ivoclar Vivadent, Inc.	IPS e.max Zirconia
2026-01-30	K254283	Prismatik Dentalcraft, Inc.	BruxZir® Shaded 16 PLUS
2026-01-09	K253973	Liaoning Upcera Co., Ltd.	Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series
2025-12-08	K252789	Shenzhen Xiangtong Co., Ltd.	Glass Ceramic
2025-09-03	K252446	Prismatik Dentalcraft, Inc.	BruxZir® NOW
2025-08-25	K251593	Denmat Holding, LLC	DenMat Multilayered Zirconia Disc
2025-07-10	K250063	Arum Dentistry Co., Ltd.	ARENA Star, Galaxy Star
2025-06-12	K250826	Dmax Co., Ltd.	Multi M Series
2025-06-05	K251084	Estetic Ceram AG	zirkon; structure; LFU shades, stains and glazes
2025-05-29	K250673	Kuraray Noritake Dental, Inc.	CERABIEN MiLai
2025-05-20	K250534	Aidite (Qinhuangdao) Technology Co., Ltd.	Biomic Color Opaque
2025-05-12	K250393	United Zirconia	ZircaGlow & ZircaGlow HT Zirconia
2025-04-11	K250811	Aidite (Qinhuangdao) Technology Co., Ltd.	Dental Zirconia Ceramic
2025-03-14	K250025	Aidite (Qinhuangdao) Technology Co., Ltd.	Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain/Glaze-A,Modeling Fluid )
2025-02-25	K250223	Prismatik Dentalcraft, Inc.	BruxZir® Esthetic NOW
2025-02-21	K243940	Vita Zahnfabrik H.Rauter GmbH & Co.	VITA YZ Multi Translucent
2024-12-05	K242740	Liaoning Rachcera Material Technology Co., Ltd.	Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO)