Direct Bond Button

GUDID 00190730007285

Lingual Button DB Rnd Base Microetched 10 pk

ORTHO TECHNOLOGY, INC.

Orthodontic metal band

• Primary Device ID: 00190730007285
• NIH Device Record Key: f887ecb4-f2b1-4ddc-9156-6ef2f8742625
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Direct Bond Button
• Version Model Number: 494-001-10
• Company DUNS: 781772017
• Company Name: ORTHO TECHNOLOGY, INC.
• Device Count: 1
• DM Exempt: true
• 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	00190730007285 [Primary]

FDA Product Code

• ECM: BAND, PREFORMED, ORTHODONTIC

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-09-22

On-Brand Devices [Direct Bond Button]

• 00190730007285: Lingual Button DB Rnd Base Microetched 10 pk
• 00190730088123: Lingual Button Direct Bond RCurve 10/pk Micro
• 00190730088116: Lingual Button Direct Bond Curved 10/pk
• 00190730088109: Lingual Button Direct Bond Flat 10/pk