Identity
- Trade Name
- ORTHO-JET CRYSTAL LIQUID FDA UDI
- Generic Name
- Dental prosthesis restorative material, unfilled resin FDA UDI
- Device Name
- FAST CURING EXTRA CLEAR ORTHODONTIC ACRYLIC RESIN LIQUID FDA UDI
- Model / Reference
- 118 ML FDA UDI
- Description
- FAST CURING EXTRA CLEAR ORTHODONTIC ACRYLIC RESIN LIQUID FDA UDI
Identifiers
- Catalog Number
- 0203C FDA UDI
- Primary DI / UDI-DI
- D6500203C0 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 Liquid by Lang Dental Manufacturing Company, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental prosthesis restorative material, unfilled resin.
- BIOCRYL XR 1# KIT — Great Lakes Dental Technologies · Class II
- 2OZ NEON PINK POWDER — Great Lakes Dental Technologies · Class II
- 2oz VIOLET DYE CONCENTRATE — Great Lakes Dental Technologies · Class II
- 1-LB TEAL MAGICRYL II POWDER — Great Lakes Dental Technologies · Class II
- 1LB APPLE RED CONTEMPORARY — Great Lakes Dental Technologies · Class II
- 2OZ BLACK RAINBOW MONOMER — Great Lakes Dental Technologies · Class II
- 1LB BLUEBERRY CONTEMPORARY — Great Lakes Dental Technologies · Class II
- BIOCRYL ICE 5# KIT — Great Lakes Dental Technologies · Class II
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 — 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 (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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Lang Dental Manufacturing Company, Inc.
Sources (1)
- FDA UDI 965580d0-f74d-4f6e-82d0-75566c462e3c 35 fields · synced May 30, 2026