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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
 
Trade NamePERI-OSS
Classification Nameimplant, endosseous, root-form
Generic Namecalcium phosphate-ceramic
Regulation Number872.3640
ApplicantMITER, INC.
PMA NumberP800035
Supplement NumberS010
Date Received06/25/2001
Decision Date10/04/2001
Product Code
DZE[ Registered Establishments with DZE ]
Advisory Committee Dental
Supplement Typenormal 180 day track
Supplement Reason labeling change - trade name
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a new trade name. The device, as modified, will be marketed under the trade name, peri-oss and is indicated for repair of periodontal and periapical bony defects.
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