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Devices
Device Recall OrthoJet Powder
Model / Serial
a.1) product code 1320, box lot 1320-4005, bottle lot 60274005/04AB; a.2) product code 040-016, lot 53-1334-4016, empty bottle and cap only; b.1) product code 1520, box lot 1520-4020, bottle lot 15144002/01AB - Blue; box lot 1520-4023, bottle lot 15244006/01AH - White; b.2) product code 045-088, box lot 53-1593-4006, bottle lots 15224001/01AQ - red, 15203002/01BS - orange, 15144002/01AA - blue and 15124003/01AP - black, and box lot 53-1593-4007, bottle lots 15124003/01AQ - black, 15144002/01AC - blue, 15203002/01BU - orange, 15224001/01AT - red, 15244006/01AF - white, 15263001/01CD - yellow; c.1) product code 2720, box lot lot 2720-4021, bottle lot 60374001/01AH -pink; box lot 2720-4022, bottle lot 60363002/01BE -yellow; box lot 2720-4023, bottle lot 60374001/01AK - pink; product code 2793, kit box lot 2793-4005, bottle lots 60343002/02AF - green, 27124001/01AF - orange, 60374001/01AJ - pink, 27164001/01AS - red, 60363002/01BD - yellow and 60353005/01AS - blue; c.2) product 045-052, box lot 53-2720-4044, bottle lot 60343002/02AE - key lime green
Product Classification
Dental Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide
Product Description
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
Manufacturer
Lang Dental Mfg Co, Inc.
1 Event
Recall of Device Recall OrthoJet Powder
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Manufacturer
Lang Dental Mfg Co, Inc.
Manufacturer Address
Lang Dental Mfg Co, Inc., 175 Messner Dr, Wheeling IL 60090-6433
Source
USFDA
Language
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