| Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device. |
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| Trade Name | PEPGEN 15 |
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| Classification Name | bone grafting material, dental, with biologic component |
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| Generic Name | endosseous implant for bone filling and/or augmentation |
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| Regulation Number | 872.3930 |
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| Applicant | DENTSPLY INTL. |
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| PMA Number | P990033 |
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| Supplement Number | S015 |
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| Date Received | 08/20/2007 |
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| Decision Date | 01/11/2008 |
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| Product Code | |
| Advisory Committee |
Dental |
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| Supplement Type | normal 180 day track no user fee |
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| Supplement Reason | location change: sterilizer |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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Approval Order Statement
Approval for a contract sterilization site located at sterigenics us, inc, gurnee, illinois. |
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