Device Classification Name |
cord, retraction
|
510(k) Number |
K053329 |
Device Name |
KORLEX-GR GINGIVAL RETRACTION PASTE |
Applicant |
BIOTECH ONE, INC. |
92 COSTA BRAVA |
LAGUNA NIGUEL,
CA
92677
|
|
Applicant Contact |
KAREN UYESUGI |
Correspondent |
BIOTECH ONE, INC. |
92 COSTA BRAVA |
LAGUNA NIGUEL,
CA
92677
|
|
Correspondent Contact |
KAREN UYESUGI |
Classification Product Code |
|
Date Received | 12/01/2005 |
Decision Date | 02/15/2006 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Dental
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|