510(k) K241924

Device: Elastic Impression Material
Applicant: Beijing Okvd Biological Technology , Ltd.
510(k) number: K241924
Product code: ELW
Decision: Substantially Equivalent (SESE)
Decision date: 2024-12-27
Date received: 2024-07-01
Regulation: 872.3660
Classification name: Material, Impression
Medical specialty: Dental
Review panel: Dental
Device class: 2
Clearance type: Abbreviated
Statement or summary: Summary
Third party reviewed: N

Related Records

Applicant Contact

Contact: Zhang Xianghao
Address: 101, 1st To 3rd Floors, Bldg. 1, Yard 5, Dasheng Rd. Shunyi District, Beijing (North Side Of 1st Floor) Beijing CN 101399 101399

FDA Registration Numbers

3025307990
3008912871
3007743883
9680144
9612300
1032227
3005172141
3006316962
3011689956
2014676
3005665377
3035693034
3011500388
3004884150
3003449480
3003941201
9680845
3012312751
3018507299
3016447764
3006191485
8020994
3012187973
9611385
1718476
1718912
8044164
3006223010
3003775534
3012041047
3011050570
3030159375
3011187729
3011649314
4565
2437780
9616065
3022516928
3004443427
2023950
3032911850
9614977
3002785217
8021038
3009496224
3010864832
9610902
3020749939
2024980
3010131268
1530561
1450653
3012477813
3003618527
3014615644
3032435508
3007353764
9681210
2244812
3012421607
2087259
3009432160
2523320
1281412
3042272797
3008648418
1410097
3008922120
3006113314
8021851
9681356
3031841433
2921595
3032193293
9614794
3005628474
8010908
2126683
9681254

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code ELW

510(k)	Device	Applicant	Decision date
K254112	Dia-X Sil Bite	DiaDent Group International	2026-03-19
K253501	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);	Vigodent Indústria E Comercio Ltda	2025-10-31
K250969	JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST	Dent4you AG	2025-06-27
K242360	Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator	Dent4you AG	2024-11-15
K233954	Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu	B&E Korea Co., Ltd.	2024-02-13
K223892	DentMix VPS Impression Material	Innovative Product Brands, Inc.	2023-04-27
K213175	No Stress Impress	No Stress Impress, LLC	2023-01-19
K214086	Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty	Genoss Co., Ltd.	2022-12-15
K222741	DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast)	Hdi, Inc.	2022-11-07
K213244	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)	Prevest Denpro Limited	2022-09-09
K221668	Dental Impression Material	Chemoment Materials Co.,Ltd	2022-08-08
K213890	IMICRYL Impression Materials	Imicryl Dis Malzemeleri San. VE Tic. A.S.	2022-02-11
K220257	Permadyne	3M Deutschland GmbH	2022-02-01
K220097	PRESIDENT The Original	Coltène/Whaledent AG	2022-01-13
K211489	Dental Impression Material	Nanchang Dental Bright Technology Co., Ltd.	2021-07-28