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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSTRAUMANN EMDOGAIN
Generic NameBiologic material, dental
Regulation Number872.3930
ApplicantThe Straumann Company
60 Minuteman Rd.
Andover, MA 01810
PMA NumberP930021
Supplement NumberS014
Date Received03/02/2015
Decision Date08/26/2015
Product Code NQA 
Advisory Committee Dental
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR ADDING THE USE OF BIPHASIC CALCIUM PHOSPHATE (HAIJ3-TCP) BONE GRAFT MATERIALS WITH STRAUMANN EMDOGAIN, ADDING THE USE OF COLLAGEN AND OTHER GRAFT MATERIALS WITH STRAUMANN EMDOGAIN AND CHANGING THE NAME OF A CONTRACT MANUFACTURER, IN NAME ONLY, FROM SVERIGE, SCAN AB TO HKSCAN SWEDEN AB. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME STRAUMANN EMDOGAIN AND IS INDICATED FOR USE AS AN ADJUNCT TO PERIODONTAL SURGERY AS A TOPICAL APPLICATION ONTO EXPOSED ROOT SURFACES. EMDOGAIN IS INDICATED FOR THE TREATMENT OF THE FOLLOWING CONDITIONS:1) INTRABONY DEFECTS DUE TO MODERATE OR SEVERE PERIODONTITIS;2) MANDIBULAR DEGREE II FURCATIONS WITH MINIMAL INTERPROXIMAL BONE LOSS; 3) GINGIVAL RECESSION DEFECTS IN CONJUNCTION WITH SURGICAL COVERAGE PROCEDURES SUCH ASTHE CORONALLY ADVANCED FLAP TECHNIQUE; AND4) EMDOGAIN IS ALSO INDICATED FOR USE IN A MINIMALLY INVASIVE SURGICAL TECHNIQUE IN ESTHETIC ZONES TO OPTIMIZE TISSUE HEIGHT FOR INTRABONY DEFECTS ONLY. IN CASES OF WIDE DEFECTS OR WHERE SOFT TISSUE SUPPORT IS DESIRED, STRAUMANN EMDOGAIN CAN BE USED IN CONJUNCTION WITH A BONE GRAFT MATERIAL. FOR FURTHER INFORMATION ON THE USE OF EMDOGAIN WITH BONE GRAFT MATERIALS, PLEASE REFER TO, FOR STRAUMANN EMDOGAIN IN CONJUNCTION WITH BONE GRAFT MATERIAL IN WIDE DEFECTS IN THE CLINICAL PROCEDURE SECTION OF THE DRAFT INSTRUCTIONS.
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