Identity
- Trade Name
- DURASEAL FDA UDI
- Generic Name
- Dental impression tray material FDA UDI
- Device Name
- TEMPORARY FILLING ACRYLIC/8 OZ. POWDER / 8 OZ. LIQUID (224 GR POWDER / 240 ML LIQUID) FDA UDI
- Model / Reference
- 2709 FDA UDI
- Description
- TEMPORARY FILLING ACRYLIC/8 OZ. POWDER / 8 OZ. LIQUID (224 GR POWDER / 240 ML LIQUID) FDA UDI
Identifiers
- Primary DI / UDI-DI
- D9472709 FDA UDI
- FDA Product Code
- EBH FDA UDI
- GMDN Term
- Dental impression tray material FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3670 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental impression tray material
Duraseal by Reliance Dental Manufacturing — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- JET TRAY POWDER — Lang Dental Manufacturing Company, Inc. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Reliance Dental Manufacturing
Sources (1)
- FDA UDI 126205ac-ab38-432e-b199-b976817d52e9 34 fields · synced Jun 1, 2026