Identity
- Trade Name
- VARIFLEX 1 LB POWDER ONLY *O FDA UDI
- Generic Name
- Dental prosthesis restorative material, unfilled resin FDA UDI
- Model / Reference
- 046-004 FDA UDI
Identifiers
- Primary DI / UDI-DI
- D7750460040 FDA UDI
- 510(k) Number
- K033632 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
No
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
Variflex 1 Lb Powder Only *o 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.
- JET DENTURE REPAIR POWDER — Lang Dental Manufacturing Company, Inc. · Class II
- JET XR POWDER — Lang Dental Manufacturing Company, Inc. · Class II
- ORTHO-JET CRYSTAL — Lang Dental Manufacturing Company, Inc. · Class II
- ORTHO-JET TINTING CONCENTRATE LIQUID — Lang Dental Manufacturing Company, Inc. · Class II
- 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
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 II | Pending data |
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Manufacturer
- Manufacturer
- Great Lakes Dental Technologies
Sources (1)
- FDA UDI 0cfbb5c3-f66a-4d7c-9e9b-8af2f4790ff8 34 fields · synced May 30, 2026