TruLock

GUDID 00885797644855

TRULOCK Primer Activated Primer 12ml

Rmo, Inc.

Orthodontic bracket adhesive

• Primary Device ID: 00885797644855
• NIH Device Record Key: 9d0db9b9-4fb0-49ad-b3d9-c0fdaf8111c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TruLock
• Version Model Number: J04013
• Company DUNS: 007058183
• Company Name: Rmo, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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	00885797644855 [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: 2024-09-02
• Device Publish Date: 2024-08-23

On-Brand Devices [TruLock]

• 00885797664914: TRULOCK Plastic Conditioner 15ml
• 00885797664907: TRULOCK Metal Conditioner 15ml
• 00885797664891: TRULOCK Porcelain Conditioner 15ml
• 00885797658296: TRULOCK Primer Activated Adhesive Kit (4ea Syringe)w/o etchant
• 00885797658289: TRULOCK Light Activated Adhesive Kit (4ea Syringe) w/o etchant
• 00885797648013: TRULOCK Primer Activated Adhesive Mini Kit (1ea Syringe) W/O Etchant
• 00885797648006: TRULOCK Light Activated Adhesive Mini Kit (1ea Syringe) W/O Etchant
• 00885797644947: TRULOCK Primer Activated Adhesive Mini Kit (1ea Syringe)
• 00885797644930: TRULOCK Primer Activated Adhesive Kit (40 Capsule)
• 00885797644923: TRULOCK Primer Activated Adhesive Kit (4ea Syringe)
• 00885797644916: TRULOCK Primer Activated Adhesive Kit (jar)
• 00885797644909: TRULOCK Light Activated Adhesive Mini Kit (1ea Syringe)
• 00885797644893: TRULOCK Light Activated Adhesive Kit (40 Capsule)
• 00885797644886: TRULOCK Light Activated Adhesive Kit (4ea Syringe)
• 00885797644879: TRULOCK Etchant Gel (12g Syringe)
• 00885797644862: TRULOCK Etchant Liquid 7ml
• 00885797644855: TRULOCK Primer Activated Primer 12ml
• 00885797644848: TRULOCK Primer Activated Adhesive (40 X .35g Capsule) 14g
• 00885797644831: TRULOCK Primer Activated Adhesive (3.5g Syringe) 4ea
• 00885797644824: TRULOCK Primer Activated Adhesive (jar) 14g
• 00885797644817: TRULOCK Light Activated Bonding Resin 7ml
• 00885797644800: TRULOCK Light Activated Adhesive (40 X .35g Capsule) 14g
• 00885797644794: TRULOCK Light Activated Adhesive (5g Syringe) 4ea
• 00885797674272: Trulock LC Band Adhesive, 5g Syringe PKG 4
• 00885797674265: TruLock LC Band Adhesive, 5g Syringe