STRAUMANN EMDOGAIN
FDA premarket approval P930021/S014 · decided 2015-08-26
Approval details
- PMA number
- P930021
- Supplement
- S014
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- STRAUMANN EMDOGAIN
- Generic name
- Biologic material, dental
- Applicant
- The Straumann Company
- Date received
- 2015-03-02
- Decision date
- 2015-08-26
- Days to decision
- 177 days
- Decision code
- APPR
- Product code
- NQA
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Andover, MA
- 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. EMD
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