Device Classification Name |
Material, Tooth Shade, Resin
|
510(k) Number |
K771882 |
Device Name |
REPLICA DENTAL COMPOSITE-RADIOPAQUE |
Applicant |
HOYT LABORATORIES |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
HOYT LABORATORIES |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 872.3690
|
Classification Product Code |
|
Date Received | 10/04/1977 |
Decision Date | 10/20/1977 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|