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Sign in to claim this brandNEOCIS INC
US
Last updated September 17, 2026
What NEOCIS INC makes
Neocis Inc manufactures dental stereotactic surgery systems, including image-guided solutions for precise oral and maxillofacial procedures. Their portfolio includes systems for surgical navigation, such as the Neocis Guidance System, as well as specialized components like YomiLink Bone and YomiLink Arch for guided implant placement and bone augmentation.
The company’s devices are regulated under FDA classifications, with most falling into Class I and Class II categories. They are listed in the FDA’s 510(k) and UDI registries, reflecting their compliance with U.S. medical device authorization requirements. The company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Neocis Inc manufacture?
Neocis Inc specializes in dental stereotactic surgery systems, focusing on image-guided solutions for oral and maxillofacial procedures. Their primary product line includes the Neocis Guidance System, a surgical navigation tool, as well as specialized components like the YomiLink Bone and YomiLink Arch, which assist in guided implant placement and bone augmentation. These devices are designed to enhance precision during complex dental surgeries.
Where is Neocis Inc based, and how does that affect its regulatory oversight?
Neocis Inc is based in the United States, which means its devices fall under the jurisdiction of the FDA (U.S. Food and Drug Administration). Since the company operates within the U.S., its products are subject to FDA regulations, including classification under the agency’s device categories (Class I or Class II) and mandatory listing in registries like the 510(k) and UDI databases to ensure compliance with U.S. medical device authorization requirements.
Which regulatory registries list Neocis Inc’s devices, and why are they important?
Neocis Inc’s devices are listed in the FDA’s 510(k) and UDI (Unique Device Identification) registries. The 510(k) registry documents premarket submissions for devices deemed substantially equivalent to existing authorized products, while the UDI system ensures traceability and transparency in the supply chain. Listing in these registries confirms compliance with U.S. regulatory requirements and helps track device performance and safety post-authorization.
How are Neocis Inc’s devices classified under FDA regulations, and what does that mean?
Neocis Inc’s devices are classified as either Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher risk and require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway for authorization, with Class II devices typically requiring a 510(k) submission to demonstrate equivalence to a predicate device before market authorization.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 545 NW 26th St, Miami, FL, 33127
- Website
- —
- —
- —
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3012787974
- DUNS Number
- 802312434
Catalogue (73)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Neocis Guidance System | DRW-1013-02 | FDA UDI | Class II | Active |
| Neocis Guidance System | DRW-0759-02 | FDA UDI | Class II | Unknown |
| Neocis Guidance System | DRW-0735-10 | FDA UDI | Class II | Active |
| Neocis Guidance System | DRW-0855-02 | FDA UDI | Class II | Unknown |
| Neocis Guidance System | DRW-0735-01 | FDA UDI | Class II | Active |
| Neocis Guidance System | DRW-0535-02 | FDA UDI | Class II | Unknown |
| Neocis Guidance System | DRW-1000-00 | FDA UDI | Class II | Active |
| Neocis Guidance System | DRW-0739-02 | FDA UDI | Class II | Unknown |
| YomiLink Bone (LL) | DRW-1357-01 | FDA UDI | Class II | Active |
| Neocis Guidance System | DRW-0735-03 | FDA UDI | Class II | Active |
| Neocis Guidance System | DRW-1012-02 | FDA UDI | Class II | Active |
| Neocis Guidance System | DRW-0467-01 | FDA UDI | Class II | Unknown |
| Neocis Guidance System | DRW-0735-04 | FDA UDI | Class I | Active |
| Neocis Guidance System | DRW-0730 | FDA UDI | Class II | Unknown |
| Neocis Guidance System | DRW-0735-09 | FDA UDI | Class II | Active |
| Neocis Guidance System | DRW-0911-01 | FDA UDI | Class II | Unknown |
| YLB-IOFA- Medium | DRW-2314-02 | FDA UDI | Class II | Active |
| YomiLink Arch (LLUR) | DRW-2208-01 | FDA UDI | Class II | Active |
| Neocis Guidance System | DRW-0735-11 | FDA UDI | Class II | Active |
| Neocis Guidance System | DRW-0020-00 | FDA UDI | Class II | Active |
| Neocis Guidance System | DRW-0735-07 | FDA UDI | Class II | Active |
| YLA Probing Bit - Contra Angle | DRW-2364-00 | FDA UDI | Class II | Active |
| Neocis Guidance System | DRW-0306-01 | FDA UDI | Class II | Unknown |
| YomiLink Teeth Posterior (LLUR) | DRW-2081-01 | FDA UDI | Class II | Active |
| Neocis Guidance System | DRW-0535-01 | FDA UDI | Class II | Unknown |
| Neocis Guidance System | DRW-1013-01 | FDA UDI | Class II | Active |
| Neocis Guidance System | DRW-1200-00 | FDA UDI | Class II | Unknown |
| Neocis Guidance System | DRW-0735-08 | FDA UDI | Class I | Active |
| Neocis Guidance System | DRW-0533-02 | FDA UDI | Class II | Unknown |
| Neocis Guidance System | DRW-0735-05 | FDA UDI | Class I | Active |
| Neocis Guidance System | DRW-0739-01 | FDA UDI | Class II | Unknown |
| Neocis Guidance System | DRW-0855-01 | FDA UDI | Class II | Unknown |
| Neocis Guidance System | DRW-0533-01 | FDA UDI | Class II | Unknown |
| Neocis Guidance System | DRW-0742-01 | FDA UDI | Class II | Unknown |
| YomiLink Teeth Posterior (LRUL) | DRW-2081-02 | FDA UDI | Class II | Active |
| YomiLink Bone (LR) | DRW-1357-02 | FDA UDI | Class II | Active |
| Neocis Guidance System | DRW-0735-02 | FDA UDI | Class II | Active |
| YomiLink Arch (LRUL) | DRW-2208-02 | FDA UDI | Class II | Active |
| Neocis Guidance System | DRW-0560-01 | FDA UDI | Class II | Unknown |
| Neocis Guidance System | DRW-1012-01 | FDA UDI | Class II | Active |
| Neocis Guidance System | DRW-0735-06 | FDA UDI | Class I | Active |
| Neocis Guidance System | DRW-0735-12 | FDA UDI | Class I | Active |
| Neocis Guidance System | DRW-0759-01 | FDA UDI | Class II | Unknown |
| Neocis Guidance System | DRW-0715-00 | FDA UDI | Class II | Unknown |
| Neocis Guidance System | DRW-0467-02 | FDA UDI | Class II | Unknown |
| YLB-IOFA- Small | DRW-2314-03 | FDA UDI | Class II | Active |
| Neocis Guidance System | DRW-0560-02 | FDA UDI | Class II | Unknown |
| Neocis Guidance System | DRW-0910-01 | FDA UDI | Class II | Unknown |
| Neocis Guidance System | DRW-0742-02 | FDA UDI | Class II | Unknown |
| Neocis Guidance System | DRW-0911-02 | FDA UDI | Class II | Unknown |
Related Companies
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FDA Recalls (5)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
NeoCis Inc. has five recall records, all initiated between October 4, 2019, and October 30, 2020, with each record marked as terminated. The reasons cited include potential mislabeling of the LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints, as well as a mismatch between the Fiducial Array and its measurement files leading to failed landmark checks.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Oct 30, 2020 | Z-0929-2021 | — | terminated | The LRUL and LLUR posterior chairside splints and the LLUR anterior chairside splints may be mislabeled. |
| May 14, 2020 | Z-2637-2020 | — | terminated | The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled. |
| May 14, 2020 | Z-2638-2020 | — | terminated | The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled. |
| May 14, 2020 | Z-2639-2020 | — | terminated | The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled. |
| Oct 4, 2019 | Z-0511-2020 | — | terminated | The Fiducial Array may mismatch their measurement files resulting in failed landmark check. |