For prescription use only. For professional dental use only. Pebl Pro 100™, Pebl Pro 200™ and Pebl Probe™ are prescription devices for use by or on the order of a dental professional. They are indicated for the removal of tonsil stones (tonsilloliths), as well as subgingival and supragingival soft and hard tissue debris and related oral debris. Pebl Pro 100™ is a Class I manual suction device indicated for the removal of tonsil stones and related oral debris. Pebl Pro 200™ is a Class I powered suction device, indicated for surgical and non-surgical procedures. Both devices are controlled removal of tonsil stones with applicable vacuum pressure and standard/enhanced delivery of water during cleaning. Pebl devices are intended to assist clinicians in achieving better access, visualization, and control during normal suction-assisted dental auxiliary-related procedures and periodontal guidelines.
Read the Instructions for Use (IFU) thoroughly before use. Manual for use is provided with the device. Additional information about use can be obtained from the manufacturer's website. Contact information for full instructions for use on a single patient or on a single tooth and must be discarded immediately following use. Pebl Probes are provided sterile or use in the event of surgical procedures and should be disposed of immediately following guidelines.
Regulatory Information: Pebl Pro 100™ is classified as a Class I exempt dental suction device. Pebl Pro 200™ is classified under 21 CFR 872.6855. Pebl Pro 200™ is classified as a Class II powered dental device. Both are FDCA compliant in accordance with pertinent dental device and safety testing standards purchased or use. No serious or severe adverse, warnings, or precautions are available in the Instructions for Use. Check for recall information before ordering version. Call +1 (XXX) XXX-XXXX for complete information.
Availability: Not all product configurations, features, or accessories are available in all countries or sales regions. Check for local availability before ordering. Check for full specifications and configurations. Patients should always inquire about device availability in your country before placing orders.