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ADA Seal Product Report

Save-A-Tooth

Phoenix Lazerus, Inc.
ADA Seal Statement 
"The ADA Council on Scientific Affairs’ Acceptance of Save-A-Tooth is based on its finding that the solution used in Save·A·Tooth has been shown to increase the survival rate of a traumatically avulsed tooth, when used as directed.  Although data show that the solution is effective up to 24 hours, the survival rate is highest if the tooth is replanted by a dentist within one hour."
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Basis for Acceptance 
A company earns the ADA Seal for its product by providing evidence that meets the ADA criteria for safety and efficacy.  The ADA Council on Scientific Affairs carefully evaluates the evidence according to the Guidelines for Participation in the ADA’s Seal of Acceptance Program

Save-A-Tooth has met current ADA requirements for safety and effectiveness for preserving teeth which included thefollowing clinical studies:

Krasner.P  et.al Management of Sports Related Tooth Displacements and Avulsions Advances in Sports Dentistry:  In this study knocked off teeth were stored in Save·A·Tooth solution system before putting back in patients mouth. The results of this study showed that after two hours in Save·A·Tooth system, 91% of the teeth were successfully replanted in patient’s mouth.

Krasner.P  Modern Treatment of Avulsed Teeth by Emergency Physicians: In this study the author  shows that success of replanted knocked off  teeth can be increased by preserving it in Save·A·Tooth System. The author describes detailed treatment plan for emergency physicians.
Brief Description of Product, Indications and Directions for Use 
  • Emergency Tooth Preserving System. Nourishes knocked-out teeth for replantation by a dentist.
  • Unscrew the Save·A·Tooth system container top and peel the safety seal, being careful not to spill the tooth preserving fluid.
  • Drop the knocked-out tooth into Save·A·Tooth system container.[Note: DO NOT RINSE OFF THE TOOTH OR ATTEMPT IN ANY WAY TO CLEAN IT OFF BEFORE DROPPING IT INTO THE CONTAINER]
  • After the tooth is in the container screw the top back onto the container making certain that no fluid has spilled out and that the top is on tightly. Hold the container upright.
  • Take the patient and the tooth to the dentist as soon as possible. The tooth will be preserved in Save·A·Tooth system for up to 24 hours. Identify patient on the “write on area” on jar.
Ingredients 
Active Ingredients:
Hank’s Balanced Salt Solution [Sodium Chloride, D-Glucose, Potassium Chloride, Sodium Bicarbonate, Sodium Phosphate (monobasic), Calcium Chloride, Magnesium Sulfate (anhydrous)]


Inactive Ingredients:
Water
Label Warnings 
  • There is no guarantee of long term retention of a replanted tooth. A small percentage of replanted knocked-out teeth will be lost even with optimum treatment.
  • To prevent the spread of infectious disease, do not place the teeth of more than one person in the same Save·A·Tooth system container.
Company Information 
Additional information about the product, including whether coupons or promotions are available, is available on the company's web site.
Phoenix Lazerus, Inc. 4524 N Lombard Street Suite A Portland, OR 97203 Ph: 971-339-3019 Ph: 888 788 6684 E-mail: saveatooth@comcast.net http://www.save-a-tooth.com