510(k) K203499
- Device
- Perfit ZR ST Dental Zirconia Blank, Perfit ZR UT Dental Zirconia Blank
- Applicant
- Vatech Acucera, Inc.
- 510(k) number
- K203499
- Product code
- EIH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-04-05
- Date received
- 2020-11-27
- 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
- No
Applicant Contact#
- Contact
- Kyung Wook Kwon
- Address
- 2544, Nambuk-Daero, Idong-Eup, Cheoin-Gu Yongin-Si KR 17138 17138
FDA Registration Numbers#
- 3012421607
- 3005554774
- 3013546336
- 3011649314
- 3017619362
- 1219645
- 3013342350
- 3021284321
- 3018252381
- 3005344553
- 3035693034
- 3011824442
- 3003310824
- 3018411778
- 3013102320
- 3008912871
- 3014945384
- 3013934196
- 3005942449
- 3024185724
- 3005904906
- 9612300
- 3031606428
- 3009312656
- 1000426619
- 3002807050
- 3009727738
- 3020611371
- 2018957
- 3004966444
- 3044771104
- 3017674095
- 3029968429
- 1420089
- 3030515618
- 3009081830
- 3009740550
- 3007597023
- 3006110126
- 3038718579
- 9612618
- 2436986
- 3038715999
- 3009432160
- 8031058
- 9681199
- 3008564629
- 3015194291
- 3000219976
- 8010711
- 3009496224
- 3006235664
- 2244842
- 3007160911
- 3040605150
- 3032163716
- 3010564008
- 3010002722
- 3008582406
- 3013513796
- 3009643402
- 1000118628
- 3008754429
- 3012354669
- 3017450159
- 3008347275
- 3025604798
- 3008190898
- 3031595584
- 1725006
- 3014683120
- 3013551048
- 3003449480
- 9613348
- 2023817
- 3042370495
- 3004905070
- 3008254125
- 3025436468
- 3013136463
Source Documents#
Other 510(k) Records For Product Code EIH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253191 | DCMhotbond zircon | Dental Creativ Management GmbH | 2026-05-21 |
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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