Device Classification Name |
material, tooth shade, resin
|
510(k) Number |
K895401 |
Device Name |
NORTHERNLIGHTS ORTHODONTIC BONDING SYSTEM |
Applicant |
ROCKY MOUNTAIN ORTHODONTICS, INC. |
P.O. BOX 17085 |
DENVER,
CO
80217
|
|
Applicant Contact |
DARRELL PARKER |
Correspondent |
ROCKY MOUNTAIN ORTHODONTICS, INC. |
P.O. BOX 17085 |
DENVER,
CO
80217
|
|
Correspondent Contact |
DARRELL PARKER |
Regulation Number | 872.3690
|
Classification Product Code |
|
Date Received | 09/07/1989 |
Decision Date | 12/04/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|