NTI - Kahla GmbH Rotary Dental Instruments MADC-010 NTI

DentiqAir is a software application for the visualization and segmentation of imaging information of the oral-maxillofacial region. The imaging data originates from medical scanners such as CT or CBCT scanners. The software is intended to create design outputs to fabricate intraoral mandibular advancement devices used for the reduction of snoring. The dental professionals' planning data may be exported from DentiqAir and used as input data for CAD or Rapid Prototyping Systems. Output of DentiqAir has not been 510(k) cleared yet. The export of the device design file should only be sent to manufacturer who hold a 510(k) for intraoral mandibular advancement devices using DentiqAir software. The manufacture of the device should occur as per the design specifications provided within the 510(k) clearance.

This database entry covers UDI for SW Versions 1.0 and higher:(01)04049471070118(10)200 -> Version 2.0; (01)04049471070118(10)201-> Version 2.0.1; (01)04049471070118(10)251-> Version 2.5.1; (01)04049471070118(10)260-> Version 2.6

Standalone software application. A universal workflow (non-medical tool) on Merge PACS platform.

Aionex Nurse Call System provides patients the ability to place a call from their patient location--patient room or other--with full nurse call functionality. The staff are aware of patient calls by visual clues outside the patient room, at a group location such as the nurse station, and/or in a centralized concierge patient response center location designated by the facility. This includes support for routine patient calls as well as emergent patient calls such as Code Blue, Bath Emergency, Bed Exit. Typical locations are clinical care settings.

Burr, Oval, 10 flute, 3.0mm

2.4mm Round Bur

4.0mm Diamond Round Bur

5.0mm Egg Bur

The subject device, AROMA GRAND is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI). It utilizes a semiconductor diode as a laser source (808nm). The laser power is delivered to the treatment area via a laser hand-piece.

DentiqAir is a software application for the visualization and segmentation of imaging information of the oral-maxillofacial region. The imaging data originates from medical scanners such as CT or CBCT scanners. The software is intended to create design outputs to fabricate intraoral mandibular advancement devices used for the reduction of snoring. The dental professionals' planning data may be exported from DentiqAir and used as input data for CAD or Rapid Prototyping Systems. Output of DentiqAir has not been 510(k) cleared yet. The export of the device design file should only be sent to manufacturer who hold a 510(k) for intraoral mandibular advancement devices using DentiqAir software. The manufacture of the device should occur as per the design specifications provided within the 510(k) clearance.

This database entry covers UDI for SW Versions 1.0 and higher:(01)04049471070118(10)200 -> Version 2.0; (01)04049471070118(10)201-> Version 2.0.1; (01)04049471070118(10)251-> Version 2.5.1; (01)04049471070118(10)260-> Version 2.6

Standalone software application. A universal workflow (non-medical tool) on Merge PACS platform.

Aionex Nurse Call System provides patients the ability to place a call from their patient location--patient room or other--with full nurse call functionality. The staff are aware of patient calls by visual clues outside the patient room, at a group location such as the nurse station, and/or in a centralized concierge patient response center location designated by the facility. This includes support for routine patient calls as well as emergent patient calls such as Code Blue, Bath Emergency, Bed Exit. Typical locations are clinical care settings.