08X KLO Metal Self-Ligating -5.2

GUDID 06970469418958

PK OF 100

Zhejiang Headway Medical Equipment Co., Ltd

Orthodontic bracket, metal

• Primary Device ID: 06970469418958
• NIH Device Record Key: 190c4eed-a9e5-46ff-af4e-7edc49d8d0e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 08X KLO Metal Self-Ligating -5.2
• Version Model Number: BR08X-C
• Company DUNS: 412892520
• Company Name: Zhejiang Headway Medical Equipment Co., Ltd
• 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	06970469418958 [Primary]

FDA Product Code

• EJF: Bracket, Metal, Orthodontic

Sterilization

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

[06970469418958]

Sound Waves

[06970469418958]

Sound Waves

[06970469418958]

Sound Waves

[06970469418958]

Sound Waves

[06970469418958]

Sound Waves

[06970469418958]

Sound Waves

[06970469418958]

Sound Waves

[06970469418958]

Sound Waves

[06970469418958]

Sound Waves

[06970469418958]

Sound Waves

[06970469418958]

Sound Waves

[06970469418958]

Sound Waves

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-04
• Device Publish Date: 2025-11-26

On-Brand Devices [08X KLO Metal Self-Ligating -5.2 ]

• 06970469418958: PK OF 100
• 06970469418576: PK OF 5