510(k) K254112
- Device
- Dia-X Sil Bite
- Applicant
- DiaDent Group International
- 510(k) number
- K254112
- Product code
- ELW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-03-19
- Date received
- 2025-12-19
- 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
- Jin An
- Address
- 16, Osongsaengmyeong 4-Ro, Osong-Eup, Heungdeok-Gu Cheongju-Si KR 28186 28186
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
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- 3030159375
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- 3011649314
- 4565
- 2437780
- 9616065
- 3022516928
- 3004443427
- 2023950
- 3032911850
- 9614977
- 3002785217
- 8021038
- 3009496224
- 3010864832
- 9610902
- 3020749939
- 2024980
- 3010131268
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- 1450653
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- 9681210
- 2244812
- 3012421607
- 2087259
- 3009432160
- 2523320
- 1281412
- 3042272797
- 3008648418
- 1410097
- 3008922120
- 3006113314
- 8021851
- 9681356
- 3031841433
- 2921595
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- 2081322
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- 3007046497
- 2086043
- 3027494823
- 3026400121
- 2515379
- 3013020540
- 2081055
- 3004793856
- 3004158247
Source Documents
Other 510(k) Records For Product Code ELW
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K241924 | Elastic Impression Material | Beijing Okvd Biological Technology , Ltd. | 2024-12-27 |
| 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 |