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The 3M™ Unitek™ Lava™ Chairside Oral Scanner is an optical impression system (CAD/CAM) used to record the topographical characteristics of teeth. Data generated from the 3M™ Unitek ™ Lava™ Chairside Oral Scanner may be used in conjunction with the production of orthodontic appliances, retainers and accessories.

The 3M™ Unitek™ Lava™ Chairside Oral Scanner is a system intended to obtain 3D images of the topographical characteristics of Teeth. The System consists of a computer, proprietary software and a hand held dental 'wand' for scanning the surface of the teeth. Using the wand in close proximity to the teeth, the image of the teeth is communicated to the software and a 3D model is created by the software. The 3D model is then stored on disk along with pertinent patient information. In this 510K pre-market notification, the software has been modified to adapt to the revised intended use statement, which adds a new device with the application of generating models for orthodontic appliances, retainers and accessories. An analysis of the changes to the device along with In-Vitro test data demonstrates that no new issues of safety or effectiveness are raised by the changes to the device discussed in this premarket notification. The 3M™ Unitek™ Lava™ Chairside Oral Scanner will be manufactured by Brontes Technologies, Inc., a 3M Company, and distributed by 3M Unitek, another 3M Company,

The 3M ESPE Lava Chairside Oral Scanner (COS) is an optical impression system (CAD/CAM) used to record the topographical characteristics of teeth.

The 3M ESPE Lava Chairside Oral Scanner (Lava COS) is a system intended to obtain 3D images of the topographical characteristics of Teeth. The System consists of a computer, proprietary software and a hand held dental 'wand' for scanning the surface of the teeth. Using the wand in close proximity to the teeth, the image of the teeth is communicated to the software and a 3D model is created by the software. The 3D model is then stored on disk along with pertinent patient information. In this 510K pre-market notification, a powdering material and powder sprayer is added as an accessory. The 'patterning powder' to be applied to the teeth prior to obtaining 3D CAD/CAM images. The powder is intended to enhance the contrast level of the image and allow for better resolution and accuracy of the CAD/CAM images obtained by the 3M ESPE Lava Chairside Oral Scanner System. This powder is similar in composition to powders sold for use with the predicate device and as a 'stand alone' material. The powder provided by Brontes meets the applicable requirements for biocompatibility under the recognized standard ISO 10993 and does not add any new issues of safety or effectiveness.