510(k) K201353
- Device
- CenterMed Patient Matched Assisted Surgical Planning (ASP) System
- Applicant
- Centermed, Inc.
- 510(k) number
- K201353
- Product code
- DZJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-06-28
- Date received
- 2020-05-21
- Regulation
- 872.4120
- Classification name
- Driver, Wire, And Bone Drill, Manual
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Christine Yu
- Address
- 226 N Wiget Ln. Walnut Creek CA US 94598 94598
FDA Registration Numbers
- 3004187715
- 3036756245
- 3015967359
- 3004464325
- 3038011206
- 1032347
- 2650143
- 3006128100
- 3014479313
- 2027754
- 1057946
- 3008812560
- 3009196021
- 3003998208
- 3011724582
- 1045834
- 3025141
- 8031010
- 8030965
- 3000270450
- 3009555447
- 3009417901
- 3015440604
- 1724955
- 3024185724
- 3027329005
- 8010177
- 3010287737
- 3033509898
- 3014833795
- 9610905
- 3015212339
- 3021635140
- 2953359
- 9614438
- 3007997036
- 1833986
- 3014483751
- 1828288
- 3015882686
- 3023852420
- 3009555440
- 3008868758
- 3010377510
- 3034676720
- 3025603301
- 3005718816
Source Documents
Other 510(k) Records For Product Code DZJ
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|---|---|---|---|
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| K220648 | OMF ASP System | Vha Dean | 2022-08-11 |
| K212570 | OsteoPlan System | Osteomed, LLC | 2022-02-11 |
| K193301 | coDiagnostiX | Dental Wings GmbH | 2021-06-21 |
| K210347 | VSP System | 3D Systems | 2021-04-26 |
| K193499 | DigiGuide System | Protomed, Inc. | 2020-11-04 |
| K192282 | MedCAD® AccuPlan® System | Medcad | 2020-10-29 |
| K181813 | ImmersiveView Surgical Plan (IVSP®) | Immersivetouch | 2020-06-09 |
| K192192 | VSP System | 3D Systems | 2020-02-26 |
| K182789 | KLS Martin Individual Patient Solutions (IPS) Planning System | KLS-Martin L.P. | 2019-03-11 |