Device Classification Name |
abutment, implant, dental, endosseous
|
510(k) Number |
K925349 |
Device Name |
ONE SYSTEM TAPERED TITANIUM ABUTMENTS |
Applicant |
IMPLANT SUPPORT SYSTEMS, INC. |
4790 IRVINE BLVD. |
#105-137 |
IRVINE,
CA
92720
|
|
Applicant Contact |
LYNN CUPERUS |
Correspondent |
IMPLANT SUPPORT SYSTEMS, INC. |
4790 IRVINE BLVD. |
#105-137 |
IRVINE,
CA
92720
|
|
Correspondent Contact |
LYNN CUPERUS |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 10/22/1992 |
Decision Date | 07/27/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|