Device Classification Name |
implant, endosseous, root-form |
|||
---|---|---|---|---|
510(k) Number | K991250 | |||
Device Name | QUANTUM VERSATILITY IMPLANT SYSTEM | |||
Applicant |
|
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Applicant Contact | raul r mena | |||
Correspondent |
|
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Correspodent Contact | raul r mena | |||
Regulation Number | 872.3640 | |||
Classification Product Code |
|
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Date Received | 04/13/1999 | |||
Decision Date | 09/20/2001 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
Dental |
|||
510k Review Panel |
Dental |
|||
summary |
summary |
|||
Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |