Identity
- Trade Name
- Emdogain FDA UDI
- Generic Name
- Periodontal root surface regeneration material FDA UDI
- Device Name
- Straumann® Emdogain 0.15 ml, Enamel Matrix Derivative 30 mg/ml, contains 5 syringes Straumann® Emdogain 0.15 ml and 5 blunt needles FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Straumann® Emdogain 0.15 ml, Enamel Matrix Derivative 30 mg/ml, contains 5 syringes Straumann® Emdogain 0.15 ml and 5 blunt needles FDA UDI
Identifiers
- Catalog Number
- 075.099 FDA UDI
- Primary DI / UDI-DI
- 07630031700025 FDA UDI
- PMA Number
- P930021 FDA UDI
- FDA Product Code
- NQA FDA UDI
- GMDN Term
- Periodontal root surface regeneration material FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 872.3930 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 0.15 Milliliter FDA UDI
Emdogain by Institut Straumann SA — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Institut Straumann SA
Sources (1)
- FDA UDI 46c2c7b1-49f9-42b2-a40b-2f3c2728f835 39 fields · synced Jun 8, 2026