510(k) K212570
- Device
- OsteoPlan System
- Applicant
- OsteoMed LLC
- 510(k) number
- K212570
- Product code
- DZJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-02-11
- Date received
- 2021-08-16
- 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
Applicant Contact#
- Contact
- Diane Rutherford
- Address
- 3885 Arapaho Rd. Addison TX US 75001 75001
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 #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243637 | Materialise Personalized Guides and Models for Craniomaxillofacial Surgery | Materialise NV | 2025-02-21 |
| K242263 | TECHFIT DISRP® System | Techfit Digital Surgery, Inc. | 2024-12-11 |
| K231520 | tmCMF Solution | Techmah Cmf | 2023-10-02 |
| K230276 | TECHFIT DISRP® System | Techfit Digital Surgery | 2023-06-23 |
| K223024 | MedCAD AccuPlan System | Medcad | 2023-03-07 |
| K220366 | EmbedMed | 3D Lifeprints UK , Ltd. | 2022-09-30 |
| K220648 | OMF ASP System | Vha Dean | 2022-08-11 |
| K201353 | CenterMed Patient Matched Assisted Surgical Planning (ASP) System | Centermed, Inc. | 2021-06-28 |
| 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 |
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