510(k) K220577
- Device
- Dental Handpiece, Model CA160, CA160L, And CA500L
- Applicant
- Micro-NX Co., Ltd.
- 510(k) number
- K220577
- Product code
- EFA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-07-29
- Date received
- 2022-02-28
- Regulation
- 872.4200
- Classification name
- Handpiece, Belt And/or Gear Driven, Dental
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Sojeong Park
- Address
- 22 Maeyeo-Ro 1 Gil Dong-Gu KR 41059 41059
FDA Registration Numbers#
- 3038718579
- 3004605493
- 2523320
- 8030870
- 3005558160
- 1054713
- 9611992
- 1223843
- 1051594
- 3012607373
- 2437780
- 3011649314
- 3007279848
- 3004884150
- 3017604
- 9680741
- 3014953747
- 3011824442
- 3011300255
- 3003610374
- 3012477813
- 3003637274
- 1419489
- 3005581016
- 3030091468
- 3012421607
- 2424472
- 9614686
- 3008693672
- 3009302876
- 3030126955
- 2086043
- 3003418325
- 3011279497
- 3007007357
- 3042272797
- 3010388675
- 9614977
- 2520265
- 3009161350
- 3009391651
- 3007958831
- 3007345485
- 3010185635
- 3027234828
- 2183301
- 1941138
- 2433629
- 3014579161
- 3014683120
- 3012336822
- 3031841433
- 9681479
- 3005405362
- 2087470
- 3004046477
- 2916440
- 3010281549
- 9681851
- 3029780
- 3002807636
- 3017619674
- 1032227
- 1319130
- 3008770655
- 1422375
- 1937639
- 3011276344
- 3002105090
- 3006540014
- 3008887731
- 2246821
- 3004082152
- 3015729
- 3006847937
- 3030235916
- 9710363
- 1722021
- 9611253
Source Documents#
Other 510(k) Records For Product Code EFA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K192809 | Dental Handpiece | Micro-Nx Co., Ltd. | 2020-08-25 |
| K163239 | SMARTmatic | Kaltenbach & Voigt GmbH | 2017-03-17 |
| K143465 | MASTERmatic LUX | Kaltenbach & Voigt GmbH | 2015-04-09 |
| K101172 | RDT3 HANDPIECE HEAD MODEL RDT3 | Redent Nova, Ltd. | 2010-07-27 |
| K093894 | ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLE | Anthogyr | 2010-03-03 |
| K092446 | INTRA LUX HEAD 3 LDSY | Kaltenbach & Voigt GmbH & Co. | 2009-11-03 |
| K090055 | LOW & HIGH SPEED KIT | Dpm USA Corp. | 2009-10-27 |
| K092412 | STRONG IMPLANT HANDPIECES | Saeshin Precision Co., Ltd. | 2009-09-03 |
| K090676 | MONTBLANC IMPLANTOLOGY AND OMNIPRATIQUE CONTRA-ANGLES | Anthogyr | 2009-05-22 |
| K070084 | MONTBLANC IMPLANTOLOGY CONTRA ANGLE CONTROL | Est. Anthogyr | 2007-03-08 |
| K061701 | HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POWER TURBINE 4H) | J. Morita USA, Inc. | 2006-08-25 |
| K061581 | EXCEL HIGH SPEED DENTAL HANDPIECE | Orthosource, Inc. | 2006-08-16 |
| K040674 | IMPLANTOLOGY CONTRA ANGLES, ENDODONTIC CONTRA ANGLES, GENERAL DENTISTRY CONTRA ANGLES | Anthogyr | 2004-06-30 |
| K013185 | TCM ENDO III | NOUVAG AG | 2001-11-28 |
| K002709 | RACE ENDODONTIC FILE | Amc General, Inc. | 2000-11-17 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases