(85 days)
The SureSmile™ System is used to provide a total orthodontic care solution to orthodontists with an image acquisition and viewing technology that delivers value throughout the entire care cycle; including record collection, treatment planning, treatment delivery, monitoring of care and patient communication.
This treatment objective is then used to design a custom appliance system, prescribed by the orthodontist, which is specific to each patient's needs. The result is a comprehensive care solution that addresses many problems that orthodontists face with patient care.
The OraScanner is not intended for use as an operative device and is not manufactured to be sterile.
The OraMetrix SureSmile System is a complete image management system capable of acquisition, transmission, archive, display and print of patient images and demographic information. Its purpose is to facilitate these operations utilizing shared data to promote the availability of information locally, remotely, and at other facilities other than which it was acquired.
The process begins by using the OraScanner to obtain a three-dimensional digital image of the dentition to provide the orthodoniist a 3-D view of the teeth. These images may be integrated with other patient records to establish a three-diment objective. This treatment objective is then used to design a custom appliance system, prescribed by the orthodontist, which is specific to each patient's needs. Follow up scans using the OraScanner allow the orthodontist to precisely monitor patient progress through the entire treatment.
Systems are configured to meet the customer's needs. Fully integrated systems could enable orthodontist to utilize speech recognition.
The general hardware configuration of the systems may contain the following major components:
-SureSmile™ OraScanner
-Monitors
-Central Processing Units (CPU, memory, disks, microphone, speakers)
-Film and Document scanners
-Digital camera
-CD-ROM writer / reader
-Optical Disk Libraries
-RAID array
-DLT Tape Libraries
-9840 Tape Libraries
-CD-R writer / reader
-DVD-R writer / reader
This 510(k) premarket notification for the SureSmile™ System, a 3-D Intraoral Camera and Accessories, does not contain a study presenting performance data against specific acceptance criteria. Instead, it demonstrates substantial equivalence to a predicate device (Spectra Vu 1000 Series Intraoral Camera and Accessories K984332).
Therefore, it is not possible to complete the requested table and answer the specific study-related questions (2-9) as the submission details a device description and its intended use, but not a study designed to prove the device meets acceptance criteria through quantitative performance metrics.
The document primarily focuses on:
- Device Description and Intended Use: Explaining what the SureSmile™ System is and what it does (acquiring, transmitting, archiving, displaying, and printing patient images and demographic information, particularly 3-D digital images of dentition using the OraScanner).
- Substantial Equivalence: Arguing that the device is substantially equivalent to a legally marketed predicate device (Spectra Vu 1000 Series Intraoral Camera and Accessories K984332) based on intended use and technological characteristics.
- Safety Information: Discussing limited patient contact, sterilization of scanner tips, and cleaning of the hand-held unit.
The absence of performance data against acceptance criteria is not uncommon for Class I devices or submissions based purely on substantial equivalence for certain types of devices, where the focus is on demonstrating that the new device does not raise new questions of safety and effectiveness compared to a predicate.
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.