KaVo Dental Technologies, LLC
Charlotte, NC, US
KaVo Dental Technologies, LLC appears in FDA device records in Charlotte, NC. FDA records list 21 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 14 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
3 namesFDA records resolved to KaVo Dental Technologies, LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Aribex, Inc.510(k), enforcement report, recall
- Pelton & Crane / Marus / DCI Equipment / KaVoenforcement report, recall
- Pelton & Crane Co.510(k), recall
510(k) clearance history
FDA records hold 21 510(k) clearances for KaVo Dental Technologies, LLC between 1976 and 2018. The busiest year on record is 1995, with 3. The most recent is 2018, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1983 | 1 |
| 1986 | 1 |
| 1990 | 1 |
| 1993 | 1 |
| 1994 | 1 |
| 1995 | 3 |
| 1996 | 2 |
| 1997 | 3 |
| 2005 | 1 |
| 2008 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2017 | 2 |
| 2018 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K171872 | P50 Series Dental Operative Unit and Accessories | EIA | Substantially Equivalent | |
| K172918 | DEXIS Titanium, KaVo IXS HD (Size 1, Size 2) | MUH | Substantially Equivalent | |
| K173319 | KaVo NOMAD Pro 2 Handheld X-ray System | EHD | Substantially Equivalent | |
| K143696 | Spirit | EIA | Substantially Equivalent | |
| K140723 | NOMAD MD 75K V HANDHELD X-RAY SYSTEM | IZL | Substantially Equivalent | |
| K081664 | NOMAD PRO X-RAY SYSTEM | EHD | Substantially Equivalent | |
| K051795 | NOMAD DENTAL X-RAY SYSTEM | EHD | Substantially Equivalent | |
| K972249 | ORTHOPHOS PLUS AND ORTHOPHOS PLUS/CD | EHD | Substantially Equivalent | |
| K972168 | SIDEXIS DIGITAL RADIOGRAPHY SYSTEM | EHD | Substantially Equivalent | |
| K945117 | DELTA | FLE | Substantially Equivalent | |
| K962071 | SPIRIT S1/S2 | EIA | Substantially Equivalent | |
| K960819 | HELIODENT DS | EAP | Substantially Equivalent | |
| K950299 | CEREC 2 | ELW | Substantially Equivalent | |
| K946187 | SPIRIT II AND SPIRIT TREATMENT CENTER | EIA | Substantially Equivalent | |
| K950030 | HELIODENT MD | EAP | Substantially Equivalent | |
| K936068 | ORTHOPHOS 3/ ORTHOPHOS 3C | EAP | Substantially Equivalent | |
| K935390 | SIROLUX FANTASTIC | EAZ | Substantially Equivalent | |
| K901672 | RESUBMITTED WATER PURIFIER FOR USE W/DENTAL TREAT | EIA | Substantially Equivalent | |
| K863484 | SIEMENS SIRONA(R) DENTAL CHAIR | KLC | Substantially Equivalent | |
| K837382 | OPTISON ULTRASONIC SCALER | Substantially Equivalent | ||
| K760404 | BI-CENTRIC SYSTEM | KLC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1017522 | 1017522 | KaVo Dental Technologies, LLC | 11727 FRUEHAUF DR, CHARLOTTE, NC 28273 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KLCChair, Dental, With Operative Unit
- NRUChair, Dental, Without Operative Unit
- EAZLight, Operating, Dental
- ELWMaterial, Impression
- FLESterilizer, Steam
- MUHSystem, X-Ray, Extraoral Source, Digital
- IZLSystem, X-Ray, Mobile
- EIAUnit, Operative Dental
- EHDUnit, X-Ray, Extraoral With Timer
- EAPUnit, X-Ray, Intraoral
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1387-2019 | 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 healthcare professionals, who are educated and competent to perform the acquisition of dental intra-oral radiographs. The DEXIS / KaVo sensor can be used either in combination with special positioning devices to facilitate positioning and alignment with the x-ray beam or it may also be positioned by hand with the assistance of the patient. | The sensor's look up calibration files were incorrectly programmed during manufacturing, which can result in the reduction of image quality. | Class II | Terminated | |
| Z-1101-2019 | cone-beam CT system | ORTHOPANTOMOGRAPH OP 3D device has a defect in the device firmware versions 2.1.0 and 2.1.1 | Class II | Open, Classified | |
| Z-2717-2016 | NOMAD Pro2 Packaged X-Ray System, Part Number 08500021; NOMAD Pro2 Packaged X-Ray System Black, Part Number 08500022; NOMAD Pro2 Vet Packaged X-Ray System, Part Number 08500023; NOMAD Pro2 Vet Packaged X-Ray System Black, Part Number 08500024; NOMAD Pro2 Packaged X-Ray System, GBL, Part Number 08500025 and Part Number 08500026; NOMAD Pro2 Packaged X-Ray System, GLB, Vet, Part Number 08500027 and Part Number 08500028; NOMAD Pro2 Package X-Ray System, GLB, Black, Part Number 08500029 | 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. | Class II | Terminated | |
| Z-2716-2016 | 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., Part Number 08500017; NOMAD Pro Packaged X-Ray System JP, Part Number 08500019 | 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. | Class II | Terminated | |
| Z-1268-2016 | 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. | Class II | Terminated | |
| Z-1177-2012 | 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 base for other dental devices, such as a dental hand piece, air/water syringe, oral cavity evacuator, a suction operative unit, and other dental devices. The TLC SAFEdrive option is an optional feature that monitors the operation of the high speed hand piece and gives an audible and visual signal to let the user know if the hand piece is potentially damaged or heating up. | 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. | Terminated | ||
| Z-1851-2011 | Pelton & Crane Spirit 1800 dental chair (Model #SP18) | 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. | Terminated | ||
| Z-1850-2011 | 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. | Terminated | ||
| Z-1326-2010 | Pelton & Crane Dental Chairs, Spirit 3000 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. | Terminated | ||
| Z-1325-2010 | Pelton & Crane Dental Chairs, Spirit 2000 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. | Terminated | ||
| Z-1324-2010 | Pelton & Crane Dental Chairs, Spirit 1800 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. | Terminated | ||
| Z-1180-2010 | Pelton & Crane Dental Chairs, Spirit 1500 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. | Terminated | ||
| Z-1179-2010 | 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. | Terminated | ||
| Z-1311-2010 | 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. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain