Identity
- Trade Name
- SPARKLE ORTHO-JET FDA UDI
- Generic Name
- Dental prosthesis restorative material, unfilled resin FDA UDI
- Device Name
- FAST CURING ORTHODONTIC ACRYLIC RESIN POWDER WITH SPARKLE FDA UDI
- Model / Reference
- 100 GRAM FDA UDI
- Description
- FAST CURING ORTHODONTIC ACRYLIC RESIN POWDER WITH SPARKLE FDA UDI
Identifiers
- Catalog Number
- 2920SP FDA UDI
- Primary DI / UDI-DI
- D6502920SP0 FDA UDI
- 510(k) Number
- K941925 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
Sparkle Ortho-Jet by Lang Dental Manufacturing Company, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Lang Dental Manufacturing Company, Inc.
Sources (1)
- FDA UDI 21458620-8cda-483c-bd65-0097761aeaad 35 fields · synced May 30, 2026