Data / Medical devices / United States / Lang Dental MFG. Co., Inc.
Lang Dental MFG. Co., Inc.: FDA-registered device maker in Wheeling, IL, United States, 10 510(k) clearances
Lang Dental MFG. Co., Inc. is registered with the FDA (registration 1417322) in Wheeling, IL, United States. It lists 3 device types. The FDA files 10 510(k) clearances under its listings, the newest dated September 2, 2016. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 1417322
- Address
- 175 Messner Dr, Wheeling, IL, United States, 60090
- Owner or operator
- LANG DENTAL MFG. CO., INC. (1417322)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- August 7, 1996
- Registered through
- 2027
- Brand names listed
- Acrylic Primer, Aurora VLC, FLEXACRYL HARD, FLEXACRYL SOFT, INSTANT TRAY MIX, JET DENTURE REPAIR, JET TOOTH SHADE, JET TRAY RESIN and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Crown And Bridge, Temporary, Resin | EBG | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Material, Impression Tray, Resin | EBH | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 2, 2016 | K152981 | JET SET 4 DENTURE REPAIR RESIN | EBI | Substantially Equivalent | Lang Dental Manufacturing Company, Inc. | accessdata.fda.gov |
| November 4, 2011 | K112397 | ORTHO-JET CRYSTAL | EBI | Substantially Equivalent | Lang Dental Mfg. Co., Inc. | accessdata.fda.gov |
| October 8, 2010 | K100653 | JET XR RADIOPAQUE ACRYLIC RESIN POWDER 45 GRAMS, JET XR RADIOPAQUE ACRYLIC RESIN POWDER 100 GRAMS, JET LIQUID 118 ML MOD | EBI | Substantially Equivalent | Lang Dental Mfg. Co., Inc. | accessdata.fda.gov |
| June 5, 2009 | K083195 | MACH 4 JET TOOTH SHADE PROVISONAL CROWN AND BRIDGE ACRYLIC RESIN | EBG | Substantially Equivalent | Lang Dental Mfg. Co., Inc. | accessdata.fda.gov |
| November 17, 2008 | K081981 | LANG DENTAL ACRYLIC PRIMER | EBI | Substantially Equivalent | Lang Dental Mfg. Co., Inc. | accessdata.fda.gov |
| September 22, 2008 | K081514 | TEMPO CUSHION TREATMENT DENTURE RELINE ACRYLIC RESIN LIQUID, PROFESSIONAL SIZE PACKAGE AND POWDER | EBI | Substantially Equivalent | Lang Dental Mfg. Co., Inc. | accessdata.fda.gov |
| September 17, 2008 | K081705 | LANG DENTAL RESINCAP PATTERN AND COPING ACRYLIC RESIN | EBG | Substantially Equivalent | Lang Dental Mfg. Co., Inc. | accessdata.fda.gov |
| November 5, 2007 | K072580 | JET DENTURE REPAIR POWDER MEHARRY 100,454 GRAMS, JET DENTURE REPAIR PROFESSIONAL PACKAGE 100 GRAMS/118ML, 1220,30,23 | EBI | Substantially Equivalent | Lang Dental Mfg. Co., Inc. | accessdata.fda.gov |
| April 18, 1996 | K960938 | PROV-KB | EBG | Substantially Equivalent | Silicon-Und Composite Spezialitaten GmbH | accessdata.fda.gov |
| May 27, 1994 | K941925 | ORTHO-JET ACRYLIC RESIN - SPARKLE | EBI | Substantially Equivalent | Lang Dental Mfg. Co., Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 7, 2004 | 29304 | Not yet classified | Terminated | Jet Tooth Shade Powder, a fast curing temporary crown and bridge acrylic; product code 1410, Net Wt. 45 g (2 oz.) plastic squeeze bottles and product code 1420, Net Wt. 100 g (4 oz.) plastic squeeze bottles; Lang Dental | The dental acrylic resin powders are contaminated with small black particles believed to be polyethylene. | accessdata.fda.gov |
Compare with other makers
- All makers of Crown And Bridge, Temporary, Resin
- All makers of Resin, Denture, Relining, Repairing, Rebasing
- All makers of Material, Impression Tray, Resin
Updated September 2, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.