ELW · Material, Impression · Chrysalis Intelligence

Device class

Class II

Regulation 872.3660

Total clearances

2020-01-30 → 2026-03-19

Last 12 months

Unique sponsors

Classification details

Medical specialty

Dental

Review panel

Regulation number

872.3660

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
Dent4you AG	2	0	2025-06-27
Osstem Implant Co., Ltd.	2	0	2021-03-18
Innovative Product Brands, Inc.	1	0	2023-04-27
Zhengzhou Huaer Electro Optics Technology Co., Ltd.	1	0	2020-10-08
DiaDent Group International	1	1	2026-03-19
B&E Korea Co., Ltd.	1	0	2024-02-13
Beijing Okvd Biological Technology , Ltd.	1	0	2024-12-27
Nanchang Dental Bright Technology Co., Ltd.	1	0	2021-07-28
Shandong Huge Dental Material Corporation	1	0	2020-09-24
Prevest Denpro Limited	1	0	2022-09-09
3M Deutschland GmbH	1	0	2022-02-01
Imicryl Dis Malzemeleri San. VE Tic. A.S.	1	0	2022-02-11
Genoss Co., Ltd.	1	0	2022-12-15
Hygedent, Inc.	1	0	2021-04-19
Hdi, Inc.	1	0	2022-11-07
Coltène/Whaledent AG	1	0	2022-01-13
Chemoment Materials Co.,Ltd	1	0	2022-08-08
Lascod Spa	1	0	2020-05-05
No Stress Impress, LLC	1	0	2023-01-19
Vigodent Indústria E Comercio Ltda	1	1	2025-10-31

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
D0140	CPT	—	High	Limited oral evaluation—problem focused; impression materials are supplies bundled to restorative codes
D2999	CPT	—	Medium	Unspecified restorative procedure; impression material supply often not separately billable

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-03-19	K254112	DiaDent Group International	Dia-X Sil Bite
2025-10-31	K253501	Vigodent Indústria E Comercio Ltda	Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set - 454g (1lb) (052327); Chroma Print Premium Fast Set - 454g (1lb) (052457); Chroma Print Premium Regular Set - 454g (1lb) (051460); Perfil Pro - 454g (1lb) (056213); Perfil Pro+ - 454g (1lb) (056121); Perfil Pro Chroma - 454g (1lb) (056122); Hydro Print Premium Fast Set - Multi Pack (056205); Hydro Print Premium Regular Set - Multi Pack (056208); Hydro Print Premium Fast Set - 9,07Kg (20lb) (056204);
2025-06-27	K250969	Dent4you AG	JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST
2024-12-27	K241924	Beijing Okvd Biological Technology , Ltd.	Elastic Impression Material
2024-11-15	K242360	Dent4you AG	Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator
2024-02-13	K233954	B&E Korea Co., Ltd.	Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu
2023-04-27	K223892	Innovative Product Brands, Inc.	DentMix VPS Impression Material
2023-01-19	K213175	No Stress Impress, LLC	No Stress Impress
2022-12-15	K214086	Genoss Co., Ltd.	Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty
2022-11-07	K222741	Hdi, Inc.	DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast)
2022-09-09	K213244	Prevest Denpro Limited	Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration)
2022-08-08	K221668	Chemoment Materials Co.,Ltd	Dental Impression Material
2022-02-11	K213890	Imicryl Dis Malzemeleri San. VE Tic. A.S.	IMICRYL Impression Materials
2022-02-01	K220257	3M Deutschland GmbH	Permadyne
2022-01-13	K220097	Coltène/Whaledent AG	PRESIDENT The Original
2021-07-28	K211489	Nanchang Dental Bright Technology Co., Ltd.	Dental Impression Material
2021-04-19	K203824	Hygedent, Inc.	VPS Impression Material
2021-03-18	K210041	Osstem Implant Co., Ltd.	HySil Plus Impression Materials
2020-10-08	K201483	Zhengzhou Huaer Electro Optics Technology Co., Ltd.	Impression Material
2020-09-24	K201684	Shandong Huge Dental Material Corporation	A-Silicone for Bite Registration
2020-05-05	K201184	Lascod Spa	Lascod Impression Materials
2020-01-30	K192941	Osstem Implant Co., Ltd.	HySil Super Fast Impression Materials