Identity
- Trade Name
- ORTHO-JET CRYSTAL FDA UDI
- Generic Name
- Dental prosthesis restorative material, unfilled resin FDA UDI
- Device Name
- FAST CURING EXTRA CLEAR ORTHODONTIC ACRYLIC RESIN POWDER AND LIQUID FDA UDI
- Model / Reference
- 5-LB PACKAGE FDA UDI
- Description
- FAST CURING EXTRA CLEAR ORTHODONTIC ACRYLIC RESIN POWDER AND LIQUID FDA UDI
Identifiers
- Catalog Number
- 0256C FDA UDI
- Primary DI / UDI-DI
- D6500256C0 FDA UDI
- 510(k) Number
- K112397 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
Ortho-Jet Crystal by Lang Dental Manufacturing Company, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental prosthesis restorative material, unfilled resin.
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Cleared under the same submission
K112397 also covers:
- BIOCRYL ICE 1# KIT — Great Lakes Dental Technologies
- BIOCRYL ICE 1# POLYMER — Great Lakes Dental Technologies
- BIOCRYL ICE 1QT MONOMER — Great Lakes Dental Technologies
- BIOCRYL ICE 5# KIT — Great Lakes Dental Technologies
- BIOCRYL ICE 5# POLYMER — Great Lakes Dental Technologies
- BIOCRYL ICE 8oz MONOMER — Great Lakes Dental Technologies
- ORTHO-JET CRYSTAL — Lang Dental Manufacturing Company, Inc.
- ORTHO-JET CRYSTAL — Lang Dental Manufacturing Company, Inc.
- ORTHO-JET CRYSTAL LIQUID — Lang Dental Manufacturing Company, Inc.
- ORTHO-JET CRYSTAL LIQUID — Lang Dental Manufacturing Company, Inc.
- ORTHO-JET CRYSTAL LIQUID — Lang Dental Manufacturing Company, Inc.
- ORTHO-JET CRYSTAL LIQUID — Lang Dental Manufacturing Company, Inc.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| 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 (2)
- FDA UDI a2864140-9c0d-4b6f-b819-6784bf14d739 35 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026