Device Classification Name |
implant, endosseous, root-form
|
510(k) Number |
K983120 |
Device Name |
BICORTICAL SCREW |
Applicant |
ORALTRONICS MARKETING-UND VERTRIEBS GMBH |
4329 GRAYDON RD. |
SAN DIEGO,
CA
92130
|
|
Applicant Contact |
FLOYD G LARSON |
Correspondent |
ORALTRONICS MARKETING-UND VERTRIEBS GMBH |
4329 GRAYDON RD. |
SAN DIEGO,
CA
92130
|
|
Correspondent Contact |
FLOYD G LARSON |
Regulation Number | 872.3640
|
Classification Product Code |
|
Date Received | 09/04/1998 |
Decision Date | 07/29/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|