Harmony Posterior Disposable Dual Arch Try

GUDID 00850211006090

Posterior Dual Arch Impression Tray for Dental Use Disposable, Rigid 50/box

HO DENTAL COMPANY LLC

Dental impression tray, single-use

• Primary Device ID: 00850211006090
• NIH Device Record Key: 6a224e2c-afcc-46c1-89d1-3f84636484f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Harmony Posterior Disposable Dual Arch Try
• Version Model Number: Posterior
• Company DUNS: 012676012
• Company Name: HO DENTAL COMPANY LLC
• Device Count: 50
• 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	00850211006090 [Primary]
GS1	00850211006472 [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

• 00850211006144 - Facial Plane Relator: 2023-05-25 This product can be used with bite registration material.The horizontal alignment bar features an arch with 25 fingers for stabi
• 00850211006021 - Vaccu-sil VPS Heavy Body 50 Impression Material: 2018-03-29 VPS Dental Impression Material for Tray Use, Heavy Body, Regular Set 4 x 50ml Cartridges
• 00850211006038 - Vaccu-sil VPS Heavy Body 50 Impression Material: 2018-03-29 VPS Impression Material for Dental Tray Use, Heavy Body, Fast Set, 4 x 50ml Cartridges
• 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: 2018-03-29 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: 2018-03-29Posterior Dual Arch Impression Tray for Dental Use Disposable, Rigid 50/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