FDA 510(k) Applications Submitted by So Hyun Park
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K250223 |
01/27/2025 |
BruxZir« Esthetic NOW |
Prismatik Dentalcraft, Inc. |
| K240240 |
01/30/2024 |
Inclusive« Titanium Abutments compatible with: Keystone« Dental PrimaConnex«, Neodent« GM, Straumann« BLX, Implant Direct« Legacy«, Implant Direct« InterActive«, Implant Direct« RePlant« Implant Systems |
Prismatik Dentalcraft, Inc. |
| K220816 |
03/21/2022 |
BruxZir NOW |
Prismatik Dentalcraft, Inc. |
| K240882 |
04/01/2024 |
BruxZir« Esthetic |
Prismatik Dentalcraft, Inc. |
| K223496 |
11/21/2022 |
Inclusive« Titanium Abutments compatible with: Straumann« Bone Level SC, BioHorizons« Tapered Internal, MIS« C1 Implant Systems |
Prismatik Dentalcraft, Inc. |
| K200131 |
01/21/2020 |
BruxZir Steel |
Prismatik Dentalcraft, Inc. |
| K230262 |
01/31/2023 |
BruxZirÖ Incisal Coloring Liquid |
Prismatik Dentalcraft, Inc. |
| K220960 |
04/01/2022 |
BruxZir Opaque Coloring Liquid |
Prismatik Dentalcraft, Inc. |
| K231097 |
04/18/2023 |
Inclusive« Titanium Abutments compatible with: Neoss« ProActive« Narrow, Neoss« ProActive« Standard, MIS« SEVEN«, Zimmer« Eztetic« Implant Systems |
Prismatik Dentalcraft, Inc. |
| K231940 |
06/30/2023 |
BruxZir« NOW SRC |
Prismatik Dentalcraft, Inc. |
| K213425 |
10/21/2021 |
BruxZir Esthetic |
Prismatik Dentalcraft, Inc. |
| K220577 |
02/28/2022 |
Dental Handpiece, Model CA160, CA160L, and CA500L |
Micro-NX Co., Ltd. |
| K192809 |
10/01/2019 |
Dental Handpiece |
Micro-NX Co., Ltd. |
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