FDA 510(k) Applications Submitted by Jia Li
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K212259 |
07/20/2021 |
Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank |
Zirdent New Material Co., Ltd |
| K200077 |
01/14/2020 |
BioMin Restore Plus |
Dr. Collins, Inc. |
| K201182 |
05/01/2020 |
iMask Disposable Surgical Face Mask |
Pac-Dent, Inc. |
| K191308 |
05/14/2019 |
U-Aligner |
Universal Orthodontic Laboratory Inc |
| K181965 |
07/23/2018 |
Restore Toothpaste |
Dr. Collins, Inc. |
| K202674 |
09/15/2020 |
Medidenta High Speed Handpieces |
Pac-Dent, Inc. |
| K202831 |
09/25/2020 |
The iMask Child's Face Mask |
Pac-Dent, Inc. |
| K202920 |
09/29/2020 |
OptiComp |
Pac-Dent, Inc. |
| K213765 |
12/01/2021 |
Glidewell 3DP Denture Base Resin |
Prismatik Dentalcraft, Inc. |
| K223798 |
12/19/2022 |
Glidewell TuffSplintÖ Appliance Resin |
Prismatik Dentalcraft, Inc. |
| K214102 |
12/29/2021 |
Glidewell Appliance Resin, Hard/Soft |
Prismatik Dentalcraft, Inc. |
| K202843 |
09/25/2020 |
Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile) |
B.J.ZH.F.Panther Medical Equipment Co., Ltd |
| K220187 |
01/24/2022 |
Medical Surgical Mask (Model: JM92, JM92B) |
Guangdong Jia Mei Biological technology Co.Ltd |
| K221173 |
04/25/2022 |
Surgical Mask (Model: 0868F, 0866F) |
Jiangxi SanHao Medical Instruments Co.,Ltd |
| K213848 |
12/10/2021 |
Medical nitrile examination gloves (Model: JL001) |
Guangdong Jiali Pharmaceutical Co.,Ltd |
| K201243 |
05/08/2020 |
Disposable Specimen Retrieval Bag |
Beijing Biosis Healing Biological Technology Co., Ltd. |
| K211586 |
05/24/2021 |
Nitrile Examination Gloves (Blue, Violet) |
Lyncmed Medical Technology (Beijing) Co., Ltd. |
| K201641 |
06/16/2020 |
Disposable Laparoscope Trocar |
Beijing Biosis Healing Biological Technology Co., Ltd. |
| K212752 |
08/30/2021 |
Med-link Pulse Oximeter |
Shenzhen Med-link Electronics Tech Co., Ltd. |
| K202743 |
09/18/2020 |
Med-Link Temp-pulse Oximeter |
Shenzhen Med-link Electronics Tech Co., Ltd |
| K163607 |
12/21/2016 |
ECG Acquisition Systems |
VALES & HILLS BIOMEDICAL TECH. LTD. |
| K202954 |
09/30/2020 |
Disposable Surgical Mask |
Xiamen Probtain Medical Techology Co., Ltd |
| K223304 |
10/27/2022 |
Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) |
Xiamen Probtain Medical Technology Co., Ltd |
| K223401 |
11/09/2022 |
Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL) |
Xiamen Probtain Medical Techology Co., Ltd |
| K223411 |
11/09/2022 |
Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) |
Xiamen Probtain Medical Techology Co., Ltd |
| K022520 |
07/30/2002 |
U2 ACETABULAR CUP |
UNITED ORTHOPEDIC CORP. |
| K210857 |
03/23/2021 |
Personal Lubricant |
Shenzhen Huanqiu Xuebao Technology Co., Ltd. |
| K202467 |
08/27/2020 |
Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads |
Fengh Medical Co., Ltd. |
| K182476 |
09/10/2018 |
Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads |
Fengh Medical Co., Ltd. |
| K222428 |
08/11/2022 |
Syngo Dynamics (Version VA40F) |
Siemens Medical Solutions USA, Inc. |
| K220143 |
01/18/2022 |
BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens |
Shenzhen Dashicheng Optical Technology Co., Ltd. |
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