TherTray1 3/4/-Arch UL-LR

GUDID 10859787002083

Disposable tray with pre-inserted thermoplastic bite wafer used for dental impressions in conjunction with final impression materials.

ADVANTAGE DENTAL PRODUCTS INC

Dental impression tray, single-use

• Primary Device ID: 10859787002083
• NIH Device Record Key: 9d7f2ba7-f1bc-432f-aacb-e3a91540dcad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TherTray1 3/4/-Arch UL-LR
• Version Model Number: 116
• Company DUNS: 607859147
• Company Name: ADVANTAGE DENTAL PRODUCTS INC
• Device Count: 24
• 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: false
• 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

Customer Support Contacts

• Phone: 248-391-1625
• Email: contact@advantagedentalinc.com
• Phone: 248-391-1625
• Email: contact@advantagedentalinc.com
• Phone: 248-391-1625
• Email: contact@advantagedentalinc.com
• Phone: 248-391-1625
• Email: contact@advantagedentalinc.com
• Phone: 248-391-1625
• Email: contact@advantagedentalinc.com
• Phone: 248-391-1625
• Email: contact@advantagedentalinc.com
• Phone: 248-391-1625
• Email: contact@advantagedentalinc.com
• Phone: 248-391-1625
• Email: contact@advantagedentalinc.com
• Phone: 248-391-1625
• Email: contact@advantagedentalinc.com
• Phone: 248-391-1625
• Email: contact@advantagedentalinc.com
• Phone: 248-391-1625
• Email: contact@advantagedentalinc.com
• Phone: 248-391-1625
• Email: contact@advantagedentalinc.com
• Phone: 248-391-1625
• Email: contact@advantagedentalinc.com
• Phone: 248-391-1625
• Email: contact@advantagedentalinc.com
• Phone: 248-391-1625
• Email: contact@advantagedentalinc.com
• Phone: 248-391-1625
• Email: contact@advantagedentalinc.com
• Phone: 248-391-1625
• Email: contact@advantagedentalinc.com
• Phone: 248-391-1625
• Email: contact@advantagedentalinc.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Use in well ventilated area. Store in cool, dry place protected from humidity. Do not store with acids and alkalis
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Use in well ventilated area. Store in cool, dry place protected from humidity. Do not store with acids and alkalis
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Use in well ventilated area. Store in cool, dry place protected from humidity. Do not store with acids and alkalis
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Use in well ventilated area. Store in cool, dry place protected from humidity. Do not store with acids and alkalis
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Use in well ventilated area. Store in cool, dry place protected from humidity. Do not store with acids and alkalis
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Use in well ventilated area. Store in cool, dry place protected from humidity. Do not store with acids and alkalis
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Use in well ventilated area. Store in cool, dry place protected from humidity. Do not store with acids and alkalis
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Use in well ventilated area. Store in cool, dry place protected from humidity. Do not store with acids and alkalis
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Use in well ventilated area. Store in cool, dry place protected from humidity. Do not store with acids and alkalis
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Use in well ventilated area. Store in cool, dry place protected from humidity. Do not store with acids and alkalis
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Use in well ventilated area. Store in cool, dry place protected from humidity. Do not store with acids and alkalis
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Use in well ventilated area. Store in cool, dry place protected from humidity. Do not store with acids and alkalis
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Use in well ventilated area. Store in cool, dry place protected from humidity. Do not store with acids and alkalis
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Use in well ventilated area. Store in cool, dry place protected from humidity. Do not store with acids and alkalis
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Use in well ventilated area. Store in cool, dry place protected from humidity. Do not store with acids and alkalis
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Use in well ventilated area. Store in cool, dry place protected from humidity. Do not store with acids and alkalis
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Use in well ventilated area. Store in cool, dry place protected from humidity. Do not store with acids and alkalis
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859787002086 [Primary]
GS1	00859787002208 [Unit of Use]
GS1	10859787002083 [Package]; Contains: 00859787002086; Package: Box [10 Units]; In Commercial Distribution

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: 2016-11-04

Devices Manufactured by ADVANTAGE DENTAL PRODUCTS INC

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• 10859787002045 - Hemaseal & Cide - Unidose: 2019-02-07 50 single dose dispensers / 0.1mL each dental desensitizer with 4% chlorhexadine
• 10859787002014 - MatrixTemp Temporary Crown and Bridge Material: 2018-03-29 Self-cure resin based impression material for the fabrication of temporary crowns and bridges
• 10859787002021 - MatrixTemp Temporary Crown and Bridge Material: 2018-03-29 Self-cure resin based impression material for the fabrication of temporary crowns and bridges
• 10859787002038 - MatrixTemp Temporary Crown and Bridge Materail: 2018-03-29 Self-cure resin based impression material for the fabrication of temporary crowns and bridges
• 10859787002052 - Temporary Crown Matrix Buttons: 2018-03-29 Thermoplastic disk used to make custom temporary crown and bridge restorations
• 10859787002069 - ThermTray1 Quadrant UL-LR: 2018-03-29 Disposable tray with pre-inserted thermoplastic bite wafer used for dental impressions in conjunction with final impression mate
• 10859787002076 - ThermTray1 Quadrant UR-LL: 2018-03-29 Disposable tray with pre-inserted thermoplastic bite wafer used for dental impressions in conjunction with final impression mate