Harmony Anterior Disposable Dual Arch Tray

GUDID 00850211006083

Anterior Dual Arch Impression Tray for Dental Use Disposable, Rigid, Alignment Sticks included to mark facial Mid-Line 40/box

HO DENTAL COMPANY LLC

Dental impression tray, single-use

• Primary Device ID: 00850211006083
• NIH Device Record Key: 91196e11-3021-4f49-84ca-3a90097bee79
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Harmony Anterior Disposable Dual Arch Tray
• Version Model Number: Anterior
• Company DUNS: 012676012
• Company Name: HO DENTAL COMPANY LLC
• Device Count: 40
• 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: false
• 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	00850211006083 [Primary]
GS1	00850211006489 [Unit of Use]

FDA Product Code

• EHY: Tray, Impression, Preformed

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: 2017-10-10

Devices Manufactured by HO DENTAL COMPANY LLC

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• 00850211006045 - Vaccu-sil VPS Light Body Cartridge: 2018-03-29 VPS Light Body Wash Material for a Dental Impression, Fast Set, 4 x 50ml Cartridges
• 00850211006052 - Vaccu-sil VPS Light Body Cartridge: 2018-03-29 VPS Light Body Wash Material for a Dental Impression, Regular Set, 4 x 50ml Cartridges
• 00850211006083 - Harmony Anterior Disposable Dual Arch Tray: 2018-03-29Anterior Dual Arch Impression Tray for Dental Use Disposable, Rigid, Alignment Sticks included to mark facial Mid-Line 40/box
• 00850211006083 - Harmony Anterior Disposable Dual Arch Tray: 2018-03-29 Anterior Dual Arch Impression Tray for Dental Use Disposable, Rigid, Alignment Sticks included to mark facial Mid-Line 40/box
• 00850211006090 - Harmony Posterior Disposable Dual Arch Try: 2018-03-29 Posterior Dual Arch Impression Tray for Dental Use Disposable, Rigid 50/box
• 00850211006205 - Vacu-Mixer Automated VPS Mixing Machine: 2018-03-29 Vacu-Mixer VPS Automated Mixing Machine, Hand Held, Rechargeable, Portable, Uses 120cc Cartridges, Comes with Stand, Adapter/Cha