Device Classification Name |
Bone Grafting Material, Human Source
|
510(k) Number |
K043573 |
Device Name |
DYNAGRAFT II DENTAL |
Applicant |
ISOTIS ORTHOBIOLOGICS, INC |
2 GOODYEAR, SUITE B |
IRVINE,
CA
92618
|
|
Applicant Contact |
PAUL DONER |
Correspondent |
ISOTIS ORTHOBIOLOGICS, INC |
2 GOODYEAR, SUITE B |
IRVINE,
CA
92618
|
|
Correspondent Contact |
PAUL DONER |
Regulation Number | 872.3930
|
Classification Product Code |
|
Date Received | 12/27/2004 |
Decision Date | 07/29/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|