510(k) K252446
- Device
- BruxZir® NOW
- Applicant
- Prismatik Dentalcraft, Inc.
- 510(k) number
- K252446
- Product code
- EIH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-09-03
- Date received
- 2025-08-04
- Regulation
- 872.6660
- Classification name
- Powder, Porcelain
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- So Hyun Park
- Address
- 2144 Michelson Dr. Irvine CA US 92612 92612
FDA Registration Numbers
- 3008912871
- 3034729565
- 9681199
- 1725006
- 3006235664
- 3008383146
- 3009907932
- 2082832
- 9612300
- 9613348
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- 3015108415
- 3002889488
- 1064583
- 3009482106
- 3008754429
- 3007597023
- 3009300369
- 3010564008
Source Documents
Other 510(k) Records For Product Code EIH
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|---|---|---|---|
| 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 |
| 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 |
| K250673 | CERABIEN MiLai | Kuraray Noritake Dental, Inc. | 2025-05-29 |
| 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 |