510(k) K250673
- Device
- CERABIEN MiLai
- Applicant
- Kuraray Noritake Dental, Inc.
- 510(k) number
- K250673
- Product code
- EIH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-05-29
- Date received
- 2025-03-06
- Regulation
- 872.6660
- Classification name
- Powder, Porcelain
- 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
- Yasujiro Ohara
- Address
- Tokiwabashi Tower, 2-6-4, Otemachi Chiyoda-Ku Tokyo JP 100-0004 100-0004
FDA Registration Numbers
- 3008912871
- 3034729565
- 9681199
- 1725006
- 3006235664
- 3008383146
- 3009907932
- 2082832
- 9612300
- 9613348
- 3010127342
- 3034244245
- 3035693034
- 3004884150
- 3003449480
- 3013551048
- 3031595584
- 3018411778
- 3008564629
- 3012187973
- 3024046877
- 3008347275
- 3005942449
- 3004966444
- 9611385
- 1718912
- 3013513796
- 3006223010
- 3000219976
- 3003775534
- 3005344553
- 3004905070
- 3011649314
- 3025436468
- 3025604798
- 3005974404
- 3030536692
- 3008578884
- 3004491043
- 3008190898
- 3021284321
- 9614977
- 3014980456
- 3009496224
- 3034729999
- 3031606428
- 9614705
- 1219645
- 3005554774
- 2916735
- 3013343038
- 3015194291
- 3018252381
- 2647456
- 3011221537
- 3040605150
- 3017674095
- 3003310824
- 8031058
- 1000426619
- 3006146796
- 3030515618
- 3012421607
- 1000118628
- 3024185724
- 3007738736
- 3013136463
- 3009740550
- 1222802
- 3011824442
- 3030464310
- 3009432160
- 2523320
- 3039433962
- 3033848620
- 3017619362
- 3042272797
- 1410097
- 2424472
Source Documents
Other 510(k) Records For Product Code EIH
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260067 | Eternal Art Porcelain Powders | Shandong Huge Dental Material Corporation | 2026-04-09 |
| K260370 | Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Bloomden Bioceramics (HuNan) Co., Ltd. | 2026-03-30 |
| K253953 | IPS e.max Zirconia | Ivoclar Vivadent, Inc. | 2026-03-10 |
| K254283 | BruxZir® Shaded 16 PLUS | Prismatik Dentalcraft, Inc. | 2026-01-30 |
| K253973 | Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series | Liaoning Upcera Co., Ltd. | 2026-01-09 |
| K252789 | Glass Ceramic | Shenzhen Xiangtong Co., Ltd. | 2025-12-08 |
| K252446 | BruxZir® NOW | Prismatik Dentalcraft, Inc. | 2025-09-03 |
| K251593 | DenMat Multilayered Zirconia Disc | Denmat Holding, LLC | 2025-08-25 |
| K250063 | ARENA Star, Galaxy Star | Arum Dentistry Co., Ltd. | 2025-07-10 |
| K250826 | Multi M Series | Dmax Co., Ltd. | 2025-06-12 |
| K251084 | zirkon; structure; LFU shades, stains and glazes | Estetic Ceram AG | 2025-06-05 |
| K250534 | Biomic Color Opaque | Aidite (Qinhuangdao) Technology Co., Ltd. | 2025-05-20 |
| K250393 | ZircaGlow & ZircaGlow HT Zirconia | United Zirconia | 2025-05-12 |
| K250811 | Dental Zirconia Ceramic | Aidite (Qinhuangdao) Technology Co., Ltd. | 2025-04-11 |
| K250025 | Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain/Glaze-A,Modeling Fluid ) | Aidite (Qinhuangdao) Technology Co., Ltd. | 2025-03-14 |