Registered with FDA
KaVo North America
Charlotte, NC, United States. Lists 3 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 3
- Brands and models
- 8
- 510(k) clearances
- 12017–2017
- Markets registered in
- 1United States
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Devices listed with FDA
What KaVo North America currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Operating LightEAZ · Class 1 | Dental operating lights | Lister | Pelton & Crane - Helios 1800 LightPelton & Crane - Helios 3000 LightPelton & Crane - Light Fantastic II | 2013 |
| Operative Dental UnitEIA · Class 1 | Dental chairs & operative units | Lister | AllianceSpirit | 2015 |
| Dental Chair without Operative UnitNRU · Class 1 | Dental chairs & operative units | Lister | Spirit 1700 Series Dental ChairSpirit 1800 Series Dental ChairSpirit 3000 Series Dental Chair | 2013 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names KaVo North America as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 18 Dec 2017 | K172918 | DEXIS Titanium, KaVo IXS HD (Size 1, Size 2) | MUH Digital Extraoral Source X-Ray System |
Some of these clearances are listed with FDA today by another company: Nobel Biocare Services AG (1), Dental Imaging Technologies Corporation (1).
Also lists devices cleared under other names
KaVo North America lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Pelton & Crane (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 18 Sep 2015 | K143696 | Spirit | Pelton & Crane | EIA Operative Dental Unit |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| KaVo Dental Technologies, LLCFDA reg. 1017522 | CHARLOTTE, NC, United States | Complaint file establishment |
Other names on FDA records
Kavo Dental Technologies, LLC
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10042898). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.