3M™ EX-1009795

GUDID 10605861085769

3M™ Orthodontic Composite

3M UNITEK CORPORATION

Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin

• Primary Device ID: 10605861085769
• NIH Device Record Key: 75a641c2-d77f-43d1-b1bf-c6affe17a0b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3M™
• Version Model Number: EX-1009795
• Catalog Number: EX-1009795
• Company DUNS: 008256356
• Company Name: 3M UNITEK CORPORATION
• 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: true
• Device Combination Product: false
• Single Use: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10605861085769 [Primary]

FDA Product Code

• DYH: ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN

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: 2024-04-05
• Device Publish Date: 2024-03-28

On-Brand Devices [3M™]

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• 00652221236395: APC™ II Clarity™ ADVANCED MBT™ Appliance System U/L 6x7 022 1 Case Kit CHk
• 00652221236388: APC™ Flash-Free Victory Series Low Profile™ MBT™ Appliance System U/L 6x7 022 1 Case Kit C
• 00652221236371: APC™ II Victory Series Low Profile™ MBT™ Appliance System U/L 6x7 022 1 Case Kit CHk
• 00652221232922: Clarity™ ADVANCED Victory Series Low Profile™ MBT™ Appliance System U/L 6x7 022 1 Case Ki
• 00652221153593: Unitek(TM) TAD Cap Elastic Ring Ea
• 00652221153579: Unitek(TM) TAD O-Cap Ea
• 00652221139306: Unitek(TM) Etching Gel System 2-Syringe w/Metal Dispensing Tip Kt
• 00652221109019: Unitek(TM) Etching Gel System 2-Syringe w/Plastic Dispensing Tip Kt
• 00652221107893: Unitek(TM) Silver Solder Heavy 025 2DWT Ea
• 00652221107886: Unitek(TM) Silver Solder Reg 015 2DWT Ea
• 00652221107879: Unitek(TM) Silver Solder Lt 010 2DWT Ea
• 00652221083715: Unitek(TM) NWO Snap-Way Headgear High-Pull Release Modules 16-32 oz. NW341 1-Pair 2/Pk
• 00652221083708: Unitek(TM) NWO Snap-Way Headgear High-Pull Release Modules 10-22 oz. NW340 1-Pair 2/Pk
• 00652221083692: NWO(TM) Snap-Way(TM) System Cervical Headgear Neckpad 7 in. Denim Blue / Release Modules 16-32 o
• 00652221083685: Unitek(TM) NWO Snap-Way Headgear High-Pull Cap Multi-Print NW340 Ea
• 00652221083678: Unitek(TM) NWO Snap-Way Headgear High-Pull Cap Black NW340 Ea
• 00652221083661: Unitek(TM) NWO Snap-Way Headgear High-Pull Cap Denim Blue NW340 Ea
• 00652221083647: Unitek(TM) NWO Snap-Way Headgear Cervical Modules 16-32 oz. NW140 10-Pair 20/Pk
• 00652221083623: Unitek(TM) NWO Snap-Way Headgear Cervical Modules 10-22 oz. NW140 10-Pair 20/Pk
• 00652221083609: Unitek(TM) NWO Snap-Way Headgear Cervical Pad 7 in. Multi-Print NW140 10/Pk
• 00652221083593: Unitek(TM) NWO Snap-Way Headgear Cervical Pad 6 in. Multi-Print NW140 10/Pk
• 00652221083579: Unitek(TM) NWO Snap-Way Headgear Cervical Pad 7 in. Denim Blue NW140 10/Pk
• 00652221083555: Unitek(TM) NWO Snap-Way Headgear Cervical Pad 6 in. Denim Blue NW140 10/Pk
• 00652221078100: Unitek(TM) Traction Release Headgear Hi-Pull C-Clips 60/Pk
• 00652221078094: Unitek(TM) Traction Release Headgear Hi-Pull Modules Medium 30-Pair 60/Pk
• 00652221078087: Unitek(TM) Traction Release Headgear Hi-Pull Cap Multi-Print 15-Small/15-Large Kt
• 00652221078070: Unitek(TM) Traction Release Headgear Hi-Pull Cap Denim Blue 15-Small/15-Large Kt
• 00652221078063: Unitek(TM) Traction Release Headgear Cervical Modules Medium 30-Pair 60/Pk
• 00652221078056: Unitek(TM) Traction Release Headgear Cervical C-Clips 60/Pk
• 00652221078049: Unitek(TM) Traction Release Headgear Hi-Pull Large Denim Blue/Medium Force 1-Patient Kt
• 00652221078032: Unitek(TM) Traction Release Headgear Hi-Pull Assorted Colors/Medium Force 8-Patient Kt
• 00652221078025: Unitek(TM) Traction Release Headgear Hi-Pull Assorted Colors/Forces 8-Patient Kt
• 00652221078018: Unitek(TM) Traction Release Headgear Cervical Medium Denim Blue/Force 1-Patient Kt
• 00652221078001: Unitek(TM) Traction Release Headgear Cervical Assorted Colors/Medium Force 10-Patient Kt
• 00652221077998: Unitek(TM) Traction Release Headgear Cervical Assorted Colors/Forces 10-Patient Kt
• 00652221077981: Unitek(TM) Traction Release Headgear Hi-Pull Cap Large Multi-Print Ea
• 00652221077974: Unitek(TM) Traction Release Headgear Hi-Pull Cap Small Multi-Print Ea
• 00652221077967: Unitek(TM) Traction Release Headgear Hi-Pull Cap Large Black Ea
• 00652221077950: Unitek(TM) Traction Release Headgear Hi-Pull Cap Small Black Ea
• 00652221077943: Unitek(TM) Traction Release Headgear Hi-Pull Cap Large Khaki Ea
• 00652221077936: Unitek(TM) Traction Release Headgear Hi-Pull Cap Small Khaki Ea
• 00652221077929: Unitek(TM) Traction Release Headgear Hi-Pull Cap Large Denim Blue Ea
• 00652221077912: Unitek(TM) Traction Release Headgear Hi-Pull Cap Small Denim Blue Ea
• 00652221077899: Unitek(TM) Traction Release Headgear Hi-Pull Modules Heavy 5-Pair 10/Pk
• 00652221077875: Unitek(TM) Traction Release Headgear Hi-Pull Modules Medium 5-Pair 10/Pk
• 00652221077851: Unitek(TM) Traction Release Headgear Hi-Pull Modules Light 5-Pair 10/Pk
• 00652221077837: Unitek(TM) Traction Release Headgear Cervical Modules Heavy 5-Pair 10/Pk