Zarc 6380038

GUDID 06941877827816

Z-Down series Endodontic Obturation Device is intended for warming and softening gutta-percha master cones and searing off gutta-percha cones. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel and not used in the oxygen-rich environment.

Changzhou Sifary Medical Technology Co., Ltd.

Endodontic obturation system

• Primary Device ID: 06941877827816
• NIH Device Record Key: c65af29a-8bac-40f5-a0fb-7d3afaea81a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zarc
• Version Model Number: Z-Down
• Catalog Number: 6380038
• Company DUNS: 560366787
• Company Name: Changzhou Sifary Medical Technology 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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
GS1	06941877827816 [Primary]

FDA Product Code

• EKR: Plugger, Root Canal, Endodontic

Sterilization

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

[06941877827816]

Moist Heat or Steam Sterilization

[06941877827816]

Moist Heat or Steam Sterilization

[06941877827816]

Moist Heat or Steam Sterilization

[06941877827816]

Moist Heat or Steam Sterilization

[06941877827816]

Moist Heat or Steam Sterilization

[06941877827816]

Moist Heat or Steam Sterilization

[06941877827816]

Moist Heat or Steam Sterilization

[06941877827816]

Moist Heat or Steam Sterilization

[06941877827816]

Moist Heat or Steam Sterilization

[06941877827816]

Moist Heat or Steam Sterilization

[06941877827816]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-13
• Device Publish Date: 2026-01-05

On-Brand Devices [Zarc]

• 06941877827823: Z-Up series Endodontic Obturation Device is intended for heating and extruding Gutta-percha into
• 06941877827816: Z-Down series Endodontic Obturation Device is intended for warming and softening gutta-percha ma
• 06941877827809: Z-Evo is a cordless endodontic treatment motorized handpiece with root canal measuring capabilit