Device Classification Name |
Agent, Tooth Bonding, Resin
|
510(k) Number |
K935735 |
Device Name |
ATTACHMENT BOND |
Applicant |
HERAEUS KULZER, INC. |
10005 MUIRLANDS BLVD. |
IRVINE,
CA
92718 -2595
|
|
Applicant Contact |
SHARON PARKER |
Correspondent |
HERAEUS KULZER, INC. |
10005 MUIRLANDS BLVD. |
IRVINE,
CA
92718 -2595
|
|
Correspondent Contact |
SHARON PARKER |
Regulation Number | 872.3200
|
Classification Product Code |
|
Date Received | 12/01/1993 |
Decision Date | 03/07/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|