510(k) K022505
- Device
- CONTRA-ANGLE, MODELS 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061, 5062, 5063, 5064, 5065, 5066, 5067, 5068,
- Applicant
- NOUVAG AG
- 510(k) number
- K022505
- Product code
- EGS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-10-01
- Date received
- 2002-07-29
- 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
- No
Applicant Contact#
- Contact
- ERICH FORSTER
- Address
- Reusswehrstrasse 1 Gebenstorf CH 5412 5412
FDA Registration Numbers#
- 3012421607
- 2183301
- 3005558160
- 3011649314
- 3011824442
- 3027234828
- 3005581016
- 3003610374
- 3030235916
- 1319130
- 3007279848
- 3013287728
- 8030870
- 1061053
- 2433629
- 3023861999
- 2916440
- 1223843
- 9611959
- 3008910197
- 3017619674
- 3003637274
- 9710363
- 3038718579
- 3009161350
- 3014579161
- 3007958831
- 3029780
- 3009302876
- 3008693672
- 1054713
- 8020776
- 3002807636
- 3007007357
- 3007345485
- 1419489
- 1937639
- 3011300255
- 3014683120
- 3014953747
- 1722021
- 3006847937
- 3005405362
- 2437780
- 3010388675
- 3002105090
- 3015729
- 2424472
- 2087470
- 3031841433
- 1422375
- 2246821
- 3012494290
- 2523320
- 9681479
- 3012336822
- 3042272797
- 3011279497
- 3004082152
- 3011276344
- 3003418325
- 9680741
- 3004884150
- 3005972890
- 9611992
- 3030126955
- 3012477813
- 9611253
- 3008770655
- 3004046477
- 2520265
- 3008887731
- 3006540014
- 1051594
- 9614686
- 3004605493
- 9614977
- 3010281549
- 3010364969
Source Documents#
Other 510(k) Records For Product Code EGS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251869 | Disposable Prophy Angle (3399-60, 3399-090, 3399-105) | Premium Plus (Dongguan) Limited | 2025-09-15 |
| 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 |
Legacy Summary#
summary
FDA Review#
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