Lang Dental Mfg Co, Inc.
Wheeling, IL, US
LANG DENTAL MFG. CO., INC. appears in FDA device records in Wheeling, IL. FDA records list 9 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 9 510(k) clearances for Lang Dental Mfg Co, Inc. between 1994 and 2011. The busiest year on record is 2008, with 3. The most recent is 2011, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 1 |
| 1997 | 1 |
| 2007 | 1 |
| 2008 | 3 |
| 2009 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K112397 | ORTHO-JET CRYSTAL | EBI | Substantially Equivalent | |
| 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 | |
| K083195 | MACH 4 JET TOOTH SHADE PROVISONAL CROWN AND BRIDGE ACRYLIC RESIN | EBG | Substantially Equivalent | |
| K081981 | LANG DENTAL ACRYLIC PRIMER | EBI | Substantially Equivalent | |
| K081514 | TEMPO CUSHION TREATMENT DENTURE RELINE ACRYLIC RESIN LIQUID, PROFESSIONAL SIZE PACKAGE AND POWDER | EBI | Substantially Equivalent | |
| K081705 | LANG DENTAL RESINCAP PATTERN AND COPING ACRYLIC RESIN | EBG | Substantially Equivalent | |
| K072580 | JET DENTURE REPAIR POWDER MEHARRY 100,454 GRAMS, JET DENTURE REPAIR PROFESSIONAL PACKAGE 100 GRAMS/118ML, 1220,30,23 | EBI | Substantially Equivalent | |
| K972553 | LANG DENTAL RESIN A97 FIBRED PINK | EBI | Substantially Equivalent | |
| K941925 | ORTHO-JET ACRYLIC RESIN - SPARKLE | EBI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1417322 | 1417322 | LANG DENTAL MFG. CO., INC. | 175 Messner Dr, WHEELING, IL 60090 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1043-04 | Jet Denture Repair Acryulic, fast curing denture repair resin; Lang Dental Manufacturing Co., Inc., Wheeling, IL 60090-0969; product code 1220, 100 gram plastic squeeze bottle and product code 1223 100 gram plastic squeeze bottle, professional package | The dental acrylic resin powders are contaminated with small black particles believed to be polyethylene. | Terminated | ||
| Z-1042-04 | Ortho-Jet Powder, fast curing orthodontic acrylic resin; the product was packaged under the following brands and sizes: a.1) Ortho-Jet Powder, Lang Dental Manufacturing Co., Inc., Wheeling, IL 60090-0969, product code 1320, 100 g plastic squeeze bottle; a.2) Biocryl Resin Acrylic, Great Lakes Orthodontics, Ltd., P.O. Box 5111, Towanda, New York 14151-5111, product code 040-016, 1 lb. lab pack with empty plastic squeeze bottle; b.1) Contemporary Colored Ortho-Jet Powder, Lang Dental, product code 1520, 100 g plastic squeeze bottle; b.2) Contemporary Colored Assorted Kit, Great Lakes Orthodontics, product code 045-088, 2 oz. plastic squeeze bottles, 6 bottles per kit; c.1) Electric Colored Ortho-Jet Powder, Lang Dental, product code 2720, 100 g plastic squeeze botles and product code 2793, 45 g plastic squeeze bottles/6 per kit; c.2) Tropical Tones Acrylic Resin, Great Lakes Orthodontics, product code 045-052, 4 oz. plastic squeeze bottle | The dental acrylic resin powders are contaminated with small black particles believed to be polyethylene. | Terminated | ||
| Z-1041-04 | 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 Manufacturing Co., Inc., Wheeling, IL 60090-0969 | The dental acrylic resin powders are contaminated with small black particles believed to be polyethylene. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain