FDA.reportPublic FDA data

PMA P930021S014

Device
STRAUMANN EMDOGAIN
Applicant
The Straumann Company
PMA number
P930021
Supplement
S014
Product code
NQA
Decision date
2015-08-26
Classification
Biologic Material, Dental
Generic name
Biologic material, dental
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.

Current openFDA PMA Record#

Device
STRAUMANN EMDOGAIN
Applicant
The Straumann Company
PMA number
P930021
Supplement
S014
Product code
NQA
Generic name
Biologic material, dental
Decision date
2015-08-26
Decision code
APPR
Date received
2015-03-02
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
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.