EBI · Resin, Denture, Relining, Repairing, Rebasing

Device class

Class II

Regulation 872.3760

Total clearances

2020-01-29 → 2026-08-27

Last 12 months

Unique sponsors

Classification details

Medical specialty

Dental

Review panel

Regulation number

872.3760

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.	4	1	2026-08-27
Sprintray, Inc.	4	0	2025-04-29
Shandong Huge Dental Material Corporation	3	1	2026-05-06
Keystone Industries	2	0	2025-05-20
Graphy, Inc.	2	1	2025-11-21
Voco GmbH	2	0	2022-09-21
Harvest Dental Products, LLC	2	0	2023-08-16
Dio Corporation	2	0	2021-03-23
Dentsply Sirona, Inc.	2	0	2024-12-17
Guangzhou Heygears IMC., Inc.	2	2	2026-08-13
Clemde SA DE CV	2	0	2025-06-03
Vertex-Dental B.V.	2	0	2024-09-04
Dentca, Inc.	2	1	2026-07-01
Deltamed GmbH	2	0	2023-04-06
Aidite (Qinhuangdao) Technology Co., Ltd.	2	0	2024-11-22
Ivoclar Vivadent, Inc.	1	0	2024-02-23
Detax GmbH	1	1	2025-10-30
Hangzhou SHINING3D Dental Technology Co., Ltd.	1	0	2025-03-31
Dreve Dentamid GmbH	1	0	2020-11-19
Detax GmbH & Co. KG	1	0	2020-11-16
Stratasys, Ltd.	1	0	2022-07-07
Dk Mungyo Corporation	1	0	2020-07-31
Asiga Pty, Ltd.	1	0	2025-04-11
Riton 3D Technology Co., Ltd.	1	0	2024-12-23
Pac-Dent, Inc.	1	0	2021-07-28

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
D5730	HCPCS	—	High	Denture relining material, standard code for denture repair and relining

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-08-27	K261802	Prismatik Dentalcraft, Inc.	Glidewell Denture Base Resin
2026-08-13	K261626	Guangzhou Heygears IMC., Inc.	UltraPrint Flexible Denture UV
2026-07-31	K262681	3BFAB TEKNOLOJI A.S.	NanoCeram Resin
2026-07-08	K262300	Formlabs Ohio, Inc.	Denture Base Resin V2
2026-07-01	K261474	Dentca, Inc.	DENTCA Tru Flexible
2026-06-02	K260569	Carbon, Inc.	DB 4000 High Impact Denture Base
2026-05-06	K260376	Shandong Huge Dental Material Corporation	Denture Base
2025-11-25	K253365	LuxCreo, Inc.	LuxCreo Flexible Partial Denture Resin
2025-11-21	K253681	Graphy, Inc.	TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HARZ Hard Denture (THD-LP-500); TERA HARZ Hard Denture (THD-LP-1000); TERA HARZ Hard Denture (THD-P-500); TERA HARZ Hard Denture (THD-P-1000); TERA HARZ Hard Denture (THD-CP-500); TERA HARZ Hard Denture (THD-CP-1000)
2025-11-20	K253324	Guangzhou Heygears IMC., Inc.	UltraPrint-Dental Denture UV
2025-10-30	K252430	Detax GmbH	Freeprint® denture flex
2025-09-17	K252035	Kamemizu Chemical Industry Co., Ltd.	DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DENTURE SOFT EX (Pink powder); DENTURE SPFT EX (White powder); DENTURE SOFT EX (Liquid); DENTURE SOFT EX (Trial kit Pink); DENTURE SOFT EX (Trial kit White)
2025-06-25	K250302	Prismatik Dentalcraft, Inc.	Flexible Partial Resin
2025-06-03	K242897	Clemde SA DE CV	Partial Flex
2025-05-20	K250489	Keystone Industries	FP3D
2025-04-29	K250617	Sprintray, Inc.	Apex Flex
2025-04-11	K243356	Asiga Pty, Ltd.	Asiga DentaBASE
2025-03-31	K250946	Hangzhou SHINING3D Dental Technology Co., Ltd.	Denture Base Resin DT20
2024-12-23	K243103	Riton 3D Technology Co., Ltd.	Denture Base
2024-12-17	K243336	Dentsply Sirona, Inc.	Lucitone Digital Print Denture System
2024-11-22	K242884	Aidite (Qinhuangdao) Technology Co., Ltd.	Additively Manufactured Denture Resin
2024-10-24	K241089	Keystone Industries	KeyPrint KeyDenture Base
2024-09-12	K241493	Prismatik Dentalcraft, Inc.	Glidewell 3DP Denture Base Resin
2024-09-04	K241071	Vertex-Dental B.V.	NextDent Jet Denture Base; NextDent Jet Denture Teeth
2024-06-20	K240688	Belport Company, Inc., Gingi-Pak	RODIN Titan 3D Resin