Device Classification Name |
agent, tooth bonding, resin
|
510(k) Number |
K042614 |
Device Name |
S&C-SELF ETCH PR-BOND |
Applicant |
S & C POLYMER GMBH |
ROBERT-BOSCH-STRASSE 5 |
ELMSHORN,
DE
D-25335
|
|
Applicant Contact |
CHRISTIAN BOETTCHER |
Correspondent |
S & C POLYMER GMBH |
ROBERT-BOSCH-STRASSE 5 |
ELMSHORN,
DE
D-25335
|
|
Correspondent Contact |
CHRISTIAN BOETTCHER |
Regulation Number | 872.3200
|
Classification Product Code |
|
Date Received | 09/24/2004 |
Decision Date | 11/22/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|