510(k) K251869
- Device
- Disposable Prophy Angle (3399-60, 3399-090, 3399-105)
- Applicant
- Premium Plus (Dongguan) Limited
- 510(k) number
- K251869
- Product code
- EGS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-09-15
- Date received
- 2025-06-18
- Regulation
- 872.4200
- Classification name
- Handpiece, Contra- And Right-Angle Attachment, Dental
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Jessica Mao
- Address
- Flat 101, #122, Tianqiao Rd., Changping Dongguan CN 523581 523581
FDA Registration Numbers#
- 1937639
- 3017619674
- 3002807636
- 2246821
- 1061053
- 3031841433
- 3009161350
- 3013287728
- 3006847937
- 9710363
- 3006540014
- 2086043
- 2433629
- 3012607373
- 3010185635
- 9680741
- 3008693672
- 3017604
- 3007279848
- 3008770655
- 3005558160
- 3003637274
- 3005405362
- 3004884150
- 9611959
- 3002105090
- 1319130
- 2424472
- 8020776
- 3038718579
- 3010364969
- 3010388675
- 3004046477
- 2916440
- 3012336822
- 3011300255
- 3027234828
- 2515379
- 3005581016
- 2520265
- 3003610374
- 3030235916
- 3011279497
- 3011276344
- 3004605493
- 3007007357
- 3015729
- 1032227
- 3003418325
- 1422375
- 9614977
- 3030091468
- 3030126955
- 3014953747
- 3008887731
- 1722021
- 3005972890
- 3011824442
- 3009391651
- 2183301
- 3042272797
- 9611253
- 3012494290
- 9681851
- 3007958831
- 9614686
- 3023861999
- 1054713
- 1941138
- 1419489
- 9681479
- 9611992
- 3011649314
- 1223843
- 2087470
- 3010281549
- 3014579161
- 3004082152
- 3014683120
- 3007345485
Source Documents#
Other 510(k) Records For Product Code EGS#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240950 | Disposable Prophy Angle | Pacific Care Limited | 2025-05-28 |
| K240183 | Star E900 Handpiece Series | Dentalez, Inc., Stardental Division | 2024-09-19 |
| K230106 | General Cutting Straight | Nakanishi, Inc. | 2023-05-24 |
| K222518 | FX Contra | Nakanishi, Inc. | 2022-11-17 |
| K220874 | Smooth Drive contra angle and straight handpieces | Lares Research | 2022-11-07 |
| K220346 | Lotus Prophy Angle | Ajk Engineering, Inc. | 2022-11-07 |
| K220577 | Dental Handpiece, Model CA160, CA160L, and CA500L | Micro-Nx Co., Ltd. | 2022-07-29 |
| K213139 | SURGmatic S15 L Pro | Kavo Dental GmbH | 2021-12-21 |
| K202960 | General Cutting Contra Handpiece | Nakanishi, Inc. | 2020-10-27 |
| K182892 | TRAUS Dental Handpieces | Saeshin Precision Co., Ltd. | 2019-11-26 |
| K182999 | General Cutting Contra Handpiece | Nakanishi, Inc. | 2019-04-16 |
| K181129 | STRONG Dental Handpieces | Saeshin Precision Co., Ltd. | 2019-01-31 |
| K171436 | STRONG Dental Handpieces | Saeshin Precision Co., Ltd. | 2018-01-05 |
| K162856 | Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE) | Bonart Co., Ltd. | 2017-07-18 |
| K162397 | Titan 3 Low Speed Angle Attachments | Dentalez, Inc. | 2017-01-19 |