Device Classification Name |
Mouthguard, Over-The-Counter
|
510(k) Number |
K150492 |
Device Name |
Ora-GUARD Dental Grind Guard |
Applicant |
Bite Tech Inc. |
20 Glover Avenue |
Norwalk,
CT
06850
|
|
Applicant Contact |
Jeff Padovan |
Correspondent |
HYMAN, PHELPS & MCNAMARA, P.C. |
700 13TH STREET NW, SUITE 1200 |
WASHINGTON,
DC
20005
|
|
Correspondent Contact |
Alex Varond |
Classification Product Code |
|
Date Received | 02/25/2015 |
Decision Date | 02/19/2016 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|