The following data is part of a premarket notification filed by Orthoaccel Technologies, Inc with the FDA for Acceledent.
Device ID | K110661 |
510k Number | K110661 |
Device Name: | ACCELEDENT |
Classification | Orthodontic Vibratory Accessory |
Applicant | ORTHOACCEL TECHNOLOGIES, INC 8275 EL RIO, SUITE 100 Houston, TX 77054 |
Contact | Michael E Kaufman |
Correspondent | Michael E Kaufman ORTHOACCEL TECHNOLOGIES, INC 8275 EL RIO, SUITE 100 Houston, TX 77054 |
Product Code | OYH |
CFR Regulation Number | 872.5470 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-03-08 |
Decision Date | 2011-11-17 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ACCELEDENT 85175399 4181657 Live/Registered |
OrthoAccel Technologies, Inc 2010-11-12 |