Data / Medical devices / United States / KaVo Dental Technologies, LLC
KaVo Dental Technologies, LLC: FDA-registered device maker in Charlotte, NC, United States, 2 510(k) clearances
KaVo Dental Technologies, LLC is registered with the FDA (registration 1017522) in Charlotte, NC, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 18, 2015. 8 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1017522
- Address
- 11727 Fruehauf DR, Charlotte, NC, United States, 28273
- Owner or operator
- KaVo North America (10042898)
- Roles
- Complaint file establishment
- First device listed
- January 9, 2013
- Registered through
- 2026
- Brand names listed
- Alliance, Delta, Delta Q, Delta XL, Pelton & Crane - Helios 1800 Light, Pelton & Crane - Helios 3000 Light, Pelton & Crane - Light Fantastic II, Spirit and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Chair, Dental, Without Operative Unit | NRU | 1 | Complaint file establishment | accessdata.fda.gov |
| Light, Operating, Dental | EAZ | 1 | Complaint file establishment | accessdata.fda.gov |
| Sterilizer, Steam | FLE | 2 | Complaint file establishment | accessdata.fda.gov |
| Unit, Operative Dental | EIA | 1 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 18, 2015 | K143696 | Spirit | EIA | Substantially Equivalent | Pelton & Crane | accessdata.fda.gov |
| February 28, 1997 | K945117 | DELTA | FLE | Substantially Equivalent | Pelton & Crane Co. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 29, 2019 | 82694 | Class II | Terminated | DEXIS Titanium Intraoral Sensor Product Usage: The DEXIS Titanium Intraoral Sensor is a USB-driven sensor which is intended to acquire dental intraoral radiographic images. The DEXIS / KaVo sensor shall be operated by he | The sensor's look up calibration files were incorrectly programmed during manufacturing, which can result in the reduction of image quality. | accessdata.fda.gov |
| December 31, 2018 | 82045 | Class II | Ongoing | cone-beam CT system | ORTHOPANTOMOGRAPH OP 3D device has a defect in the device firmware versions 2.1.0 and 2.1.1 | accessdata.fda.gov |
| July 18, 2016 | 74975 | Class II | Terminated | NOMAD Pro Packaged X-Ray System, Part Number 08500009; NOMAD Pro Vet Packaged X-Ray System, Part Number 08500011; NOMAD Pro Packaged X-Ray System - Europe, Part Number 08500013; NOMAD Pro X-Ray System, Remote Config., Pa | Firm received customer complaints where end users reported that Nomad Pro and Pro 2 handsets had appeared to "overheat", "melt", "smoke" and/or "ignite." Investigation found that the internal lithium ion batteries had entered into a thermal runaway condition as a result of a short circuit on the battery pack PCB. | accessdata.fda.gov |
| March 8, 2016 | 73460 | Class II | Terminated | Helios HL3T and HLT Track Mounted Dental Lights Product Usage: The product is intended for use by dental professionals to illuminate the oral cavity while performing examinations and dental procedures. | The firm received two customer complaints local Pelton & Crane distributors that the Helios 3000 track mounted dental lights were missing the two 8/32x3/16 set screws during the initial installation of the dental light. | accessdata.fda.gov |
| February 20, 2012 | 61262 | Not yet classified | Terminated | Pelton & Crane Spirit 3000 dental operative unit with the TLC SAFEdrive option, 1727 Fuehauf Dr. Charlotte, NC 28273 Product Usage: The intended use of the dental operative unit is for supplying power and to serve as a b | Modification of the Pelton & Crane Spirit 3000 unit disabled the TLC SAFEdrive feature rendering it ineffective in detecting whether the handpiece is potentially damaged or heating up. | accessdata.fda.gov |
| March 4, 2011 | 58105 | Not yet classified | Terminated | Pelton & Crane Spirit 3000 dental chair (Model #SP30) | The Link Arm Assembly that connects some rear mounted options to the Spirit 3000 or Spirit 1800 dental chairs may potentially break and fall off the dental chair. | accessdata.fda.gov |
| February 24, 2010 | 54719 | Not yet classified | Terminated | Pelton & Crane Dental Chairs, Chairman 5000 with magnetic headrest, Pelton & Crane, Charlotte, NC 28273. Intended for the properly positioning of patients to perform dental procedures. | Magnetic headrests may affect patients with implantable pacemakers and defibrillators. | accessdata.fda.gov |
| February 9, 2010 | 54809 | Not yet classified | Terminated | Pelton & Crane Spirit 3000 Dental Chair. The intended use of this device is for properly positioning patients to perform dental procedures. | The Dental Chair lacks a valid Device History Record. | accessdata.fda.gov |
Compare with other makers
- All makers of Unit, Operative Dental
- All makers of Chair, Dental, Without Operative Unit
- All makers of Sterilizer, Steam
- All makers of Light, Operating, Dental
Updated September 18, 2015. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.