Biologic Material, Dental
Basic Information
- Device Name
- Biologic Material, Dental
- Trade Name
- EMDOGAIN GEL
- PMA Number
- P930021
- Supplement Number
- S005
- Device Class
- FDA Class 3
- Product Code
- NQA
- Generic Name
- Biologic material, dental
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Advisory Committee
- Dental
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- June 4, 2002
- Date Received
- July 26, 2000
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR THE REVISIONS TO THE PACKAGE INSERT AS LISTED BELOW BASED ON NEW DATA THAT HAS BEEN PRESENTED IN THIS PMA SUPPLEMENT. 1) INCLUSION OF THE FOLLOWING STATEMENT IN THE CLINICAL CONSIDERATIONS SECTION: "HISTOLOGICAL STUDIES HAVE DEMONSTRATED RESULTS RANGING FROM COMPLETE PERIODONTAL REGENERATION (NEWLY FORMED CEMENTUM, PERIODONTAL LIGAMENT, AND ALVEOLAR BONE) TO REPAIR INCLUDING NEW CONNECTIVE TISSUE ATTACHMENT (CONNECTIVE TISSUE ADAPTATION VIA NEW CEMENTUM) AND A NEW ATTACHMENT MEDIATED BY AN EPITHELIAL ATTACHMENT (LONG JUNCTIONAL EPITHELIUM). THE LONG-TERM STABILITY OF THE REGENERATED TISSUE HAS NOT BEEN ESTABLISHED. AS IN ANY PERIODONTAL SURGICAL THERAPY, DEFECT MORPHOLOGY, SURGICAL TECHNIQUE AND HOST RESPONSE ARE IMPORTANT PARAMETERS FOR SUCCESSFUL OUTCOMES." 2) INCLUSION OF THE FOLLOWING STATEMENTS IN THE CLINICAL CONSIDERATIONS SECTION: A) PATIENTS TEND TO REPORT LESS POST-SURGICAL DISCOMFORT; B) CLINICIANS HAVE REPORTED ON ENHANCED WOUND HEALING.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NQA | Biologic Material, Dental | FDA class 3 | Dental |