Medit i500 (2018): an $18,000 open-system intraoral scanner with no license fees, and the FDA category that needs no clearance letter

What it says#

The announcement is short and it is a distributor's. On June 21, 2018, Inside Dental Technology reported that Axsys Dental Solutions had entered into an agreement with Medit to distribute the i500 intraoral scanner. Two numbers carried the story: an $18,000 price and no license fees. The rest of the item describes a high-speed dual camera system for photogrammetry, powderless operation, a lightweight body with a fine tip, and an intelligent scan detecting algorithm that "easily picks up where it left off if the scanning process is interrupted." On the open-system point it is specific: "It uses an open CAD/CAM system, meaning operators can export STL files out of the MeditLINK management software and instantly share them with the dental lab." On accuracy it claims that "its colored scans can distinguish between soft tissue, plaque, and tooth enamel with a precision of 25 microns across the full arch."

The quotation in the item is from Steve Braykovich, president of Axsys Incorporated, and it is a distributor talking about a product he sells: "We diligently researched intraoral scanners and found the Medit i500 meets all of our stringent requirements for speed, flexibility, accuracy, and reliability, at a price that is affordable and accessible to all." Read it as an advertisement.

Medit's own product page for the i500 is no longer served to automated requests; the version read for this entry is the Internet Archive snapshot of May 18, 2021, and this page says so rather than pretending otherwise. That page describes the same open system for STL export, an intelligent scan-detecting algorithm with two high-speed cameras, powderless scanning in most regular cases, a 280 gram handpiece, single-button control, 3D full-color video capture, and the Medit Link platform for sending scan data to laboratories. Its accuracy panel prints in vitro trueness and in vivo precision figures in micrometers, with the in vitro test attributed to Yonsei University College of Dentistry under the title "Accuracy comparison analysis on scan data of single tooth, quadrant, and full arch between two types of intraoral scanner, i500 and Trios 3," by Ji-Man Park, dated December 19, 2018, and the in vivo test attributed to Medit itself. Because the archived table's rows and columns do not survive extraction cleanly, this page does not restate those micrometer values.

The regulatory record is the part most write-ups get wrong. There is no FDA clearance letter for this scanner because its device class does not require one. The FDA's product classification for code NOF reads: "system, optical impression, computer assisted design and manufacturing (cad/cam) of dental restorations," regulation 872.3661, review panel Dental, premarket review by the Division of Dental and ENT Devices, Device Class 2, and Submission Type: 510(K) Exempt. What exists instead is establishment registration and device listing: Medit Corp., Seoul, registration number 3021233709, establishment type "Manufacture Medical Device," with a product listing under NOF created March 22, 2017 and a proprietary name list that includes the i500. Medit USA, Inc. of Newport Beach, California registered separately (number 3032480536) as an initial importer with its own NOF listing created February 25, 2024.

Who it applies to#

Any practice that has bought a scanner, is shopping for one, or is being sold one. The i500's significance is economic rather than clinical: a scanner at $18,000 with no per-scan or license fee, exporting an open STL, changed what a general dentist could expect to pay and what strings came attached.

It applies to the lab relationship too. An open STL means the file leaves the office and goes to whichever lab the dentist chooses. That is a contract question as much as a technology question, and it is the question to ask about any scanner before signing.

The independent evidence about the device itself is thin and specific, which is normal for hardware. A 2019 study in PLoS One by Kim, Benic and Park scanned a 3D-printed partially edentulous mandible model with six implant cylinders using five scanners (CEREC Omnicam, CS3600, i500, iTero Element and TRIOS 3) against a reference scanner, ten scans each, and reported that "TRIOS 3 and i500 outperformed the other IOSs for partially edentulous digital impression," that deviation generally increased with distance from the scanning start point, and that "the accuracy of IOS is still an area that needs to be improved." A 2025 systematic review and meta-analysis in Evidence-Based Dentistry looked at how scanning speed and distance affect accuracy and found a statistically significant sensitivity only for TRIOS 3, with "no significant effects observed for TRIOS 4, Primescan, or Medit i500."

What changed#

In 2018 an intraoral scanner was still commonly sold as a system with recurring costs attached: license fees, per-scan or per-case charges, or a closed file format that steered the case to the manufacturer's own mill or preferred lab. The i500 announcement is a record of the other model arriving at a general-practice price, and it is worth keeping because it is dated and specific.

What did not change is the regulatory picture, and this entry exists partly to correct it: an intraoral scanner sold as an optical impression system for CAD/CAM does not carry an FDA clearance in the United States, because the class is exempt from premarket notification. A scanner that adds a caries-detection feature is a different matter, and the FDA's own 510(k) records show those cleared under a separate product code.

Where the source is#

The source link is the news item published June 21, 2018 by the Aegis Dental Network, which now redirects to Inside Dental Technology at insidedentaltech.com; the byline is "News Staff" and the content is a distribution announcement, not independent reporting. Medit's own i500 product page is read here through an Internet Archive snapshot dated May 18, 2021 (web.archive.org/web/20210518235350/https://www.medit.com/dental-clinic-i500), because medit.com refuses automated requests; that archive link is not listed among the downloads because the archive itself rate-limits automated checks, but it opens in a browser. The regulatory documents are all FDA: the product classification page for code NOF, the text of 21 CFR 872.3661 on the eCFR, and the establishment registration and device listing records returned by the FDA's own openFDA endpoint, which show Medit Corp.'s and Medit USA's listings, their registration numbers and the dates each listing was created. The two independent studies are the PLoS One article, which is open access and reachable in full at journals.plos.org, and the Evidence-Based Dentistry meta-analysis, whose full text is behind a publisher paywall and whose results are quoted here from the PubMed abstract.