Atlas FDA

Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu

FDA 510(k) clearance K233954 · decided 2024-02-13

Clearance details

K-number
K233954
Device name
Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu
Applicant
B&E Korea Co., Ltd.
Decision
Substantially Equivalent
Date received
2023-12-15
Decision date
2024-02-13
Days to decision
60 days
Clearance type
Traditional
Product code
ELW
Device class
2
Regulation number
872.3660
Medical specialty
Dental
Advisory committee
Dental
Location
Hwaseong-Si, KR
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch B&E Korea Co.

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Dia-X Sil Bite (K254112)DiaDent Group International2026-03-19
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); (K253501)Vigodent Indústria E Comercio Ltda2025-10-31
JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST (K250969)Dent4you AG2025-06-27
Elastic Impression Material (K241924)Beijing Okvd Biological Technology , Ltd.2024-12-27
Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator (K242360)Dent4you AG2024-11-15
DentMix VPS Impression Material (K223892)Innovative Product Brands, Inc.2023-04-27
No Stress Impress (K213175)No Stress Impress, LLC2023-01-19
Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty (K214086)Genoss Co., Ltd.2022-12-15
DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast) (K222741)Hdi, Inc.2022-11-07
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) (K213244)Prevest Denpro Limited2022-09-09
Dental Impression Material (K221668)Chemoment Materials Co.,Ltd2022-08-08
IMICRYL Impression Materials (K213890)Imicryl Dis Malzemeleri San. VE Tic. A.S.2022-02-11

Recalls involving this device

No recalls on record reference this clearance.