JMU

GUDID D930315010010

JMU Dental Impression Materials, Putty-Normal Set, 400g Base + 400g Catalyst and 2 Measuring Spoons

JMU DENTAL, INC

Silicone dental impression material

• Primary Device ID: D930315010010
• NIH Device Record Key: 90479dcb-cdc4-449c-8b06-bb1fb00ac241
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JMU
• Version Model Number: 31501001
• Company DUNS: 081258380
• Company Name: JMU DENTAL, INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D930315010010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133071

FDA Product Code

• ELW: Material, Impression

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-29
• Device Publish Date: 2024-07-19

On-Brand Devices [JMU]

• D930253010040: Gloves, Nitrile,3.5mil, Size XL, Pale Violet, 100pcs/Box
• D930253010080: JMU Disposable Nitrile Exam Gloves, Powder-free, Non-Sterile, Ambidextrous, Size XL, Blue, 100pc
• D930253010070: JMU Disposable Nitrile Exam Gloves, Powder-free, Non-Sterile, Ambidextrous, Size L, Blue, 100pcs
• D930253010060: JMU Disposable Nitrile Exam Gloves, Powder-free, Non-Sterile, Ambidextrous, Size M, Blue, 100pcs
• D930253010050: JMU Disposable Nitrile Exam Gloves, Powder-free, Non-Sterile, Ambidextrous, Size S, Blue, 100pcs
• D930253010120: JMU Nitrile Examination Gloves, 3.9+/-0.3g, Size XL, Powder-Free, Non-Sterile, Blue, 200pcs/box
• D930253010110: JMU Nitrile Examination Gloves, 3.3+/-0.3g, Size L, Powder-Free, Non-Sterile, Blue, 200pcs/box
• D930253010100: JMU Nitrile Examination Gloves, 3.0+/-0.3g, Size M, Powder-Free, Non-Sterile, Blue, 200pcs/box
• D930253010090: JMU Nitrile Examination Gloves, 2.7g+/-0.3g, Size S, Powder-Free, Non-Sterile, Blue, 200pcs/box
• D930253010130: JMU Nitrile Examination Gloves, 2.5+/-0.3g, Size XS, Powder-Free, Non-Sterile, Blue, 200pcs/box
• D930253010210: JMU M3.0g Disposable Nitrile Examination Gloves, Size L, Finger Texture, Powder Free, Non-steril
• D930253010200: JMU M3.0g Disposable Nitrile Examination Gloves, Size M, Finger Texture, Powder Free, Non-steril
• D930253010190: JMU M3.0g Disposable Nitrile Examination Gloves, Size S, Finger Texture, Powder Free, Non-steril
• D930253010180: JMU M3.0g Disposable Nitrile Examination Gloves, Size XS, Finger Texture, Powder Free, Non-steri
• D930253010270: JMU M3.0g Nitrile Examination Gloves, Size XL, Powder-Free, Non-Sterile, Black, 200pcs/box
• D930253010260: JMU M3.0g Nitrile Examination Gloves, Size L, Powder-Free, Non-Sterile, Black, 200pcs/box
• D930253010250: JMU M3.0g Nitrile Examination Gloves, Size M, Powder-Free, Non-Sterile, Black, 200pcs/box
• D930253010240: JMU M3.0g Nitrile Examination Gloves, Size S, Powder-Free, Non-Sterile, Black, 200pcs/box
• D930253010230: JMU M3.0g Nitrile Examination Gloves, Size XS, Powder-Free, Non-Sterile, Black, 200pcs/box
• D930321160120: Autoclave Sterilization Wrap Sheets (CSR), 60gsm SMMS Non-Woven, 36"x36", blue, 50pcs/bag, 250pc
• D930321160110: Autoclave Sterilization Wrap Sheets (CSR), 60gsm SMMS Non-Woven, 30"x30", blue, 50pcs/bag, 250pc
• D930321160100: Autoclave Sterilization Wrap Sheets (CSR), 60gsm SMMS Non-Woven, 24"x24", blue, 50pcs/bag, 500pc
• D930321160090: Autoclave Sterilization Wrap Sheets (CSR), 60gsm SMMS Non-Woven, 18"x18", blue, 50pcs/bag, 500pc
• D930321160080: Autoclave Sterilization Wrap Sheets (CSR), crepe paper, 60grams, 18"x18", blue, 100pcs/bag, 1000
• D930321160070: Autoclave Sterilization Wrap Sheets (CSR), crepe paper, 60grams, 12"x12", blue, 100pcs/bag, 1000
• D930253010440: JMU M3.5g Premium Nitrile Examination Gloves, Size XL, Powder-Free, Non-Sterile, Violet Blue, 20
• D930253010430: JMU M3.5g Premium Nitrile Examination Gloves, Size L, Powder-Free, Non-Sterile, Violet Blue, 200
• D930253010420: JMU M3.5g Premium Nitrile Examination Gloves, Size M, Powder-Free, Non-Sterile, Violet Blue, 200
• D930253010410: JMU M3.5g Premium Nitrile Examination Gloves, Size S, Powder-Free, Non-Sterile, Violet Blue, 200
• D930253010400: JMU M3.5g Premium Nitrile Examination Gloves, Size XS, Powder-Free, Non-Sterile, Violet Blue, 20
• D930253010280: JMU M3.5g Premium Nitrile Examination Gloves, Size XS, Aloe Coasted, Powder-Free, Non-Sterile, P
• D930253020080: JMU M5.5g Premium Latex Examination Gloves, Size XL, Polymer Coasted, Powder-free, Non-Sterile,
• D930253020070: JMU M5.5g Premium Latex Examination Gloves, Size L, Polymer Coasted, Powder-free, Non-Sterile, W
• D930253020060: JMU M5.5g Premium Latex Examination Gloves, Size M, Polymer Coasted, Powder-free, Non-Sterile, W
• D930253020050: JMU M5.5g Premium Latex Examination Gloves, Size S, Polymer Coasted, Powder-free, Non-Sterile, W
• D930253020040: JMU M5.5g Premium Latex Examination Gloves, Size XS, Polymer Coasted, Powder-free, Non-Sterile,
• D930253010320: JMU M3.5g Premium Nitrile Examination Gloves, Size XL, Aloe Coasted, Powder-Free, Non-Sterile, P
• D930253010310: JMU M3.5g Premium Nitrile Examination Gloves, Size L, Aloe Coasted, Powder-Free, Non-Sterile, Pi
• D930253010300: JMU M3.5g Premium Nitrile Examination Gloves, Size M, Aloe Coasted, Powder-Free, Non-Sterile, Pi
• D930253010290: JMU M3.5g Premium Nitrile Examination Gloves, Size S, Aloe Coasted, Powder-Free, Non-Sterile, Pi
• D930145080090: JMU Surgical Carbide Burs, Straight Fissure Crosscut, FG SURG #558, 5/pk (ISO No. 107/012)
• D930145080080: JMU Surgical Carbide Burs, Straight Fissure Crosscut, FG SURG #557, 5/pk (ISO No. 107/010)
• D930145080070: JMU Surgical Carbide Burs, Taper Fissure Crosscut, FG SURG #702, 5/pk (ISO No. 168/016)
• D930145080060: JMU Surgical Carbide Burs, Taper Fissure Crosscut, FG SURG #701, 5/pk (ISO No. 168/012)
• D930145080050: JMU Surgical Carbide Burs, Taper Fissure Crosscut, FG SURG #700, 5/pk (ISO No. 168/010)
• D930145080040: JMU Surgical Carbide Burs, Round, FG SURG #8, 5/pk (ISO No. 001/023)
• D930145080030: JMU Surgical Carbide Burs, Round, FG SURG #6, 5/pk (ISO No. 001/018)
• D930145080020: JMU Surgical Carbide Burs, Round, FG SURG #4, 5/pk (ISO No. 001/014)
• D930145080010: JMU Surgical Carbide Burs, Round, FG SURG #2, 5/pk (ISO No. 001/010)
• D930145030040: JMU Surgical Carbide Burs, Round, RA SURG #6, 5/pk (ISO No. 001/018)