A free, neutral directory of dental devices and the companies behind them
Dental Device Guide answers three questions for dealers, buyers and manufacturers: who makes a given dental device, what a given company makes, and what FDA has cleared.
What is in it
- 3,592 companies that currently list a dental device with FDA, and the 4,089 establishments they register.
- 330 device types (FDA product codes), arranged into 46 categories.
- 96,725 brand and model names taken from the companies' own device listings.
- 12,836 510(k) clearances from 1976 to today, and 2,420 earlier applicant names that are no longer registered.
Where the data comes from
Three public FDA files, read through openFDA: establishment registration and device listing, 510(k) premarket notifications, and product classification. We take a dated copy of each, keep it unchanged, and build the site from that copy.
- FDA files updated
- 2 Nov 2026
- Our copy taken
- 12 Nov 2026
- Records read
- 44,935
For the other markets we read the registries of 34 regulators through Pure Global AI and match the manufacturer and holder names in them to these companies, under the same rule as below. The full record of any registration is at Pure Global AI; this guide links to it.
Both dates are shown at the foot of every page. A page never shows the day the site was built as if it were the date of the data.
How records are attached to a company
FDA gives each registered owner a number, and we use it as the company's identity. A 510(k) names its applicant only in words, and one company files under several spellings and addresses. We attach an applicant to a registered company when the name matches and one more fact agrees: the company lists that very clearance, it is in the same country, or it lists the same device type.
A name on its own is never enough. When a second fact is missing, the applicant keeps its own page, marked as not currently registered. That is why Dentsply International and Dentsply Sirona are two pages that point to each other: the clearances were filed under the first name and are listed today under the second.
What a listing means
- Maker: the company manufactures the device, has it made under contract, or owns its specifications.
- Lister: the company repacks, relabels, imports or distributes a device that someone else makes.
- Country: where the company has an FDA-registered establishment. A group with plants in three countries appears under all three.
What it does not tell you
- Registration and listing are filings by the company. FDA does not approve or endorse a company by registering it.
- Many dental devices are exempt from 510(k). A company with no clearances can be a large manufacturer.
- A company enters the guide through FDA's files, so makers that do not sell in the United States are not here yet.
- Outside the United States we show how many registrations a company has in a market, of all device types. Which of them are dental is not yet marked, and a company named differently in a registry (in Korean or Chinese, for example) may be missing from that market.
- Nothing here is medical or regulatory advice.
Independence
Every company in FDA's files is listed, free. Order on a page follows the stated rule, usually makers first and recent clearances next. A company can add its own material to its page; that does not change where it appears.
Dental Device Guide is not affiliated with FDA or with any company listed. Product images on category pages are illustrations, not photographs of a particular product.