5 results
·
68ms
·
Sources: EU EUDAMED, US FDA
ADAPTABLE CLASS III MASK
FDA Adverse Event
Injury
·GREAT LAKES ORTHODONTICS, LTD.·Product code DZB·July 31, 2011
ADAPTABLE CLASS III MASK
FDA Adverse Event
Injury
·GREAT LAKES ORTHODONTICS LTD·Product code DZB·August 30, 2011
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
FDA Recall
Terminated
·Lang Dental Mfg Co, Inc.·Product code EBG·June 7, 2004
Ortho Organizers GmbH
Importer
🇩🇪 Germany·34 Manufacturers
Emergo Europe B.V.
Authorized representative
🇳🇱 Netherlands·900 Manufacturers·22100 Devices