Manufacturer registered with FDA
Lang Dental Mfg. Co., Inc.
WHEELING, IL, United States. Lists 3 dental device types with FDA across 1 registered establishment, and holds 9 510(k) clearances as applicant.
- Device types listed
- 3
- Brands and models
- 21
- 510(k) clearances
- 91994–2011
- Markets registered in
- 552 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 1990–2026
Registered in 5 markets
Where regulators' registries name Lang Dental Mfg. Co., Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Lang Dental Mfg. Co., Inc. | 9 clearances | 1994–2011 | Below |
| Canada | Health Canada | Registration holder | LANG DENTAL MFG COMPANY INC | 30 | 1999–2017 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | LANG DENTAL MFG. CO., INC. | 14 | 2005–2021 | Pure Global AI |
| South Korea | MFDS | Manufacturer | LANG DENTAL MFG. CO., INC.LANG DENTAL MFG. CO. INC. · LANG DENTAL MFG. CO., INC · +1 | 7 | 1998–2001 | Pure Global AI |
| Israel | AMAR | Manufacturer | lang dental MFG co | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Lang Dental Mfg. Co., Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | Acrylic PrimerFLEXACRYL HARDFLEXACRYL SOFTJet Denture RepairJet Set 4 Denture Repair ResinJet XRORTHO-JETOrtho-Jet Acrylic Resin - SparkleOrtho-Jet CrystalPREMIUM 2 moreSELF CURING DENTURETempo | 2007 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | Jet Set-4JET TOOTH SHADEMach 4 Jet Tooth Shade AcrylicPulseTempResincapSPLINTLINE | 2009 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | Aurora VLCINSTANT TRAY MIXJET TRAY RESIN | 1996 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Lang Dental Mfg. Co., Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 4 Nov 2011 | K112397 | ORTHO-JET CRYSTAL | EBI Rebasing Repairing Relining Denture Resin |
| 8 Oct 2010 | K100653 | JET XR RADIOPAQUE ACRYLIC RESIN POWDER 45 GRAMS, JET XR RADIOPAQUE ACRYLIC RESIN POWDER 100 GRAMS, JET LIQUID 118 ML MOD | EBI Rebasing Repairing Relining Denture Resin |
| 5 Jun 2009 | K083195 | MACH 4 JET TOOTH SHADE PROVISONAL CROWN AND BRIDGE ACRYLIC RESIN | EBG Resin Temporary Crown and Bridge |
| 17 Nov 2008 | K081981 | LANG DENTAL ACRYLIC PRIMER | EBI Rebasing Repairing Relining Denture Resin |
| 22 Sep 2008 | K081514 | TEMPO CUSHION TREATMENT DENTURE RELINE ACRYLIC RESIN LIQUID, PROFESSIONAL SIZE PACKAGE AND POWDER | EBI Rebasing Repairing Relining Denture Resin |
| 17 Sep 2008 | K081705 | LANG DENTAL RESINCAP PATTERN AND COPING ACRYLIC RESIN | EBG Resin Temporary Crown and Bridge |
| 5 Nov 2007 | K072580 | JET DENTURE REPAIR POWDER MEHARRY 100,454 GRAMS, JET DENTURE REPAIR PROFESSIONAL PACKAGE 100 GRAMS/118ML, 1220,30,23 | EBI Rebasing Repairing Relining Denture Resin |
| 13 Nov 1997 | K972553 | LANG DENTAL RESIN A97 FIBRED PINK | EBI Rebasing Repairing Relining Denture Resin |
| 27 May 1994 | K941925 | ORTHO-JET ACRYLIC RESIN - SPARKLE | EBI Rebasing Repairing Relining Denture Resin |
Some of these clearances are listed with FDA today by another company: Great Lakes Dental Technologies, Ltd. (1).
Also lists devices cleared under other names
Lang Dental Mfg. Co., Inc. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Lang Dental Manufacturing Co., Inc. (1), Silicon-Und Composite Spezialitaten GmbH (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 2 Sep 2016 | K152981 | JET SET 4 DENTURE REPAIR RESIN | Lang Dental Manufacturing Co., Inc. | EBI Rebasing Repairing Relining Denture Resin |
| 18 Apr 1996 | K960938 | PROV-KB | Silicon-Und Composite Spezialitaten GmbH | EBG Resin Temporary Crown and Bridge |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| LANG DENTAL MFG. CO., INC.FDA reg. 1417322 | WHEELING, IL, United States | Complaint file establishment, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 1417322). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.