510(k) K233954
- Device
- Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu
- Applicant
- B&E Korea Co., Ltd.
- 510(k) number
- K233954
- Product code
- ELW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-02-13
- Date received
- 2023-12-15
- Regulation
- 872.3660
- Classification name
- Material, Impression
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Jayong Shin
- Address
- 995-16, Baran-Ro, Jeongnam-Myeon Hwaseong-Si KR 18515 18515
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
- 3030268763
- 3010407924
- 3005558160
- 3015332784
- 3006694515
- 3007028587
- 3012494290
- 3003103749
- 2024312
- 3012354669
- 3010664129
- 2081322
- 2435946
- 1316092
- 9614573
- 3008320092
- 3008966075
- 3008792854
- 2411797
- 3014683120
- 1721647
- 2183301
- 9611458
- 3038718579
- 3032312561
- 3005176727
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- 3023401336
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- 3015143007
- 3015527834
- 3013012934
- 8021059
- 3003120666
- 2431069
- 3007046497
- 2086043
- 3027494823
- 3026400121
- 2515379
- 3013020540
- 2081055
- 3004793856
- 3004158247
Source Documents
Other 510(k) Records For Product Code ELW
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|---|---|---|---|
| K254112 | Dia-X Sil Bite | DiaDent Group International | 2026-03-19 |
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| K250969 | JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST | Dent4you AG | 2025-06-27 |
| K241924 | Elastic Impression Material | Beijing Okvd Biological Technology , Ltd. | 2024-12-27 |
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| 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 |