First time experience on the Surgical Robotics - AquaBeam (De Novo granted on 12/21/2017, DEN170024)

* Three 510(k) Submissions: All FDA Cleared! * PRIMUS 200 R1 Software 2.0 (OCT- Optical Coherence Tomography): K163195 * Retina Workplace Software 2.0 (FORUM PAC's for OCT & Fundus data): K170638 * Laser Fluorescence Mode Caries Detection on Surgical Microscope: K171007 (Original Submitter) * Regulatory Assessment Process: Change Impact Assessment, Project Management, Product & Process V&V, Laser Report, Risk Assessment & Memo to File, Regulatory Strategy Planning and Considerations.

* Seven Regulatory Submissions: All Cleared! * K151088 & K151514- Dental Restoratives and Composites. K152349- Dental Impression Materials * K142880 & K142881- Orthodontic Adhesive and Band Cement. K142886- Dental Adhesive/Primer * Health Canada new Class 3 License (93796- Dental NanoFlowable & NanoComposite in 2014) * Global Regulatory Affairs, Product Registration in Health Canada, Taiwan, Japan, Brazil, China, etc, * Management Representative per ISO/EN ISO 13485

* Managing the Quality System transitions under the new international standards * Global Regulatory Affairs in supporting the facility and product registration * Managing Site Closing, Site Expanding and Product & Process Transferring * Preparing Global Sites/Organizations passing Certification Audits on QMS & EMS