Device Classification Name |
agent, tooth bonding, resin |
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---|---|---|---|---|
510(k) Number | K960365 | |||
Device Name | ALPHA-DENT HEMA DESENTIZER(748-000)/WITH FLUORIDE(747-000) | |||
Applicant |
|
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Applicant Contact | abner t de la cruz | |||
Correspondent |
|
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Correspodent Contact | abner t de la cruz | |||
Regulation Number | 872.3200 | |||
Classification Product Code |
|
|||
Date Received | 01/25/1996 | |||
Decision Date | 03/28/1996 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
Dental |
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510k Review Panel |
Dental |
|||
Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |