The following data is part of a premarket notification filed by Reliance Orthodontic Products, Inc. with the FDA for Light Cure Retainer.
Device ID | K101951 |
510k Number | K101951 |
Device Name: | LIGHT CURE RETAINER |
Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
Applicant | RELIANCE ORTHODONTIC PRODUCTS, INC. 1540 WEST THORNDALE AVE. Itasca, IL 60143 |
Contact | Paula Wendland |
Correspondent | Paula Wendland RELIANCE ORTHODONTIC PRODUCTS, INC. 1540 WEST THORNDALE AVE. Itasca, IL 60143 |
Product Code | DYH |
CFR Regulation Number | 872.3750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-07-12 |
Decision Date | 2010-10-26 |
Summary: | summary |