Dental Stereotaxic Instrument
FDA product code PLV · 22 cleared devices
Class 2
Dental
- Regulation
- 21 CFR 872.4120
- Review panel
- DE
- Implant
- No
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 2016-09-08 – 2025-10-28
To facilitate dental implant placement in patients that are partially endentulous or edentulous.
PLV
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PLV
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Yomi Robotic System
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2023-08-14
Yomi Robotic System
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2022-06-27
Navident
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2022-06-14
Yomi Robotic System with YomiPlan Go
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2022-02-22
INLIANT Surgical Navigation System
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2021-12-22
Neocis Guidance System (NGS) with Yomi Plan v2.0.1
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2021-07-28
Neocis Guidance System (NGS) with Intraoral Fiducial Array
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PLV
2020-12-15
Neocis Guidance System (NGS) with Patient Splints (EPS)
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PLV
2020-12-04
Neocis Guidance System (NGS) with Yomi Plan v2.0
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PLV
2020-10-19
Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS)
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PLV
2020-07-28
Neocis Guidance System (NGS) with Patient Splints
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2020-05-21
X-Guide® Surgical Navigation System
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PLV
2020-05-08
Neocis Guidance System (NGS) with Fiducial Array Splint (FAS)
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PLV
2020-02-03
X-Guide Surgical Navigation System
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PLV
2019-10-02
Neocis Planning Software Application (NPSA) for 3rd Party PCs
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PLV
2019-09-11
Neocis Guidance System (NGS)
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PLV
2018-12-21
Neocis Guidance System
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PLV
2018-02-22
Neocis Guidance System (NGS) with Chairside Splint
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PLV
2016-12-22
Neocis Guidance System
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PLV
2016-09-08
Navident
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