Company ยท US
Lang Dental Mfg. Co., Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1994 to 2011. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 4, 2011 | K112397 | ORTHO-JET CRYSTAL Lang Dental Mfg. Co., Inc. | EBI |
| Oct 8, 2010 | K100653 | JET XR RADIOPAQUE ACRYLIC RESIN POWDER 45 GRAMS, JET XR RADIOPAQUE ACRYLIC RESIN POWDER 100 GRAMS, JET LIQUID 118 ML MOD Lang Dental Mfg. Co., Inc. | EBI |
| Jun 5, 2009 | K083195 | MACH 4 JET TOOTH SHADE PROVISONAL CROWN AND BRIDGE ACRYLIC RESIN Lang Dental Mfg. Co., Inc. | EBG |
| Nov 17, 2008 | K081981 | LANG DENTAL ACRYLIC PRIMER Lang Dental Mfg. Co., Inc. | EBI |
| Sep 22, 2008 | K081514 | TEMPO CUSHION TREATMENT DENTURE RELINE ACRYLIC RESIN LIQUID, PROFESSIONAL SIZE PACKAGE AND POWDER Lang Dental Mfg. Co., Inc. | EBI |
| Sep 17, 2008 | K081705 | LANG DENTAL RESINCAP PATTERN AND COPING ACRYLIC RESIN Lang Dental Mfg. Co., Inc. | EBG |
| Nov 5, 2007 | K072580 | JET DENTURE REPAIR POWDER MEHARRY 100,454 GRAMS, JET DENTURE REPAIR PROFESSIONAL PACKAGE 100 GRAMS/118ML, 1220,30,23 Lang Dental Mfg. Co., Inc. | EBI |
| Nov 13, 1997 | K972553 | LANG DENTAL RESIN A97 FIBRED PINK Lang Dental Mfg. Co., Inc. | EBI |
| May 27, 1994 | K941925 | ORTHO-JET ACRYLIC RESIN - SPARKLE Lang Dental Mfg. Co., Inc. | EBI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Lang Dental Mfg Co, Inc. 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 10 Terminated |
EBI | None listed |
| Jul 20, 2004 | Lang Dental Mfg Co, Inc. 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 60090-0 Terminated |
EBG | None listed |
| Jul 20, 2004 | Lang Dental Mfg Co, Inc. 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 b Terminated |
EBG | None listed |