Identity
- Trade Name
- 1LB SPLINT POLYMER CLEAR FDA UDI
- Generic Name
- Dental prosthesis restorative material, unfilled resin FDA UDI
- Device Name
- 1LB SPLINT POLYMER CLEAR FDA UDI
- Model / Reference
- 040-010 FDA UDI
- Description
- 1LB SPLINT POLYMER CLEAR FDA UDI
Identifiers
- Catalog Number
- 040-010 FDA UDI
- Primary DI / UDI-DI
- D7750400100 FDA UDI
- FDA Product Code
- EBI FDA UDI
- GMDN Term
- Dental prosthesis restorative material, unfilled resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3760 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental prosthesis restorative material, unfilled resin
1lb Splint Polymer Clear by Great Lakes Dental Technologies — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental prosthesis restorative material, unfilled resin.
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- FLUORESCENT ORTHO-JET POWDER — Lang Dental Manufacturing Company, Inc. · Class II
- CONTEMPORARY ORTHO-JET LIQUID — Lang Dental Manufacturing Company, Inc. · Class II
- ORTHO-JET LIQUID — Lang Dental Manufacturing Company, Inc. · Class II
- JET DENTURE REPAIR — Lang Dental Manufacturing Company, Inc. · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- Great Lakes Dental Technologies
Sources (1)
- FDA UDI 465bfe24-8e8c-43c8-9fd4-643adb1c75b7 35 fields · synced May 30, 2026