Candid Impression Kit

GUDID 00850004223024

August 2020 Promo

CANDID CARE CO.

Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material

• Primary Device ID: 00850004223024
• NIH Device Record Key: b858cf47-2abb-4ae9-817a-d22be3e0760c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Candid Impression Kit
• Version Model Number: IKHELLO00001
• Company DUNS: 108729170
• Company Name: CANDID CARE CO.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• Manufacturing Date: false
• Expiration Date: true
• 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: 917-754-2056
• Email: dan.michaeli@candidco.com
• Phone: 917-754-2056
• Email: dan.michaeli@candidco.com
• Phone: 917-754-2056
• Email: dan.michaeli@candidco.com
• Phone: 917-754-2056
• Email: dan.michaeli@candidco.com
• Phone: 917-754-2056
• Email: dan.michaeli@candidco.com
• Phone: 917-754-2056
• Email: dan.michaeli@candidco.com
• Phone: 917-754-2056
• Email: dan.michaeli@candidco.com
• Phone: 917-754-2056
• Email: dan.michaeli@candidco.com
• Phone: 917-754-2056
• Email: dan.michaeli@candidco.com
• Phone: 917-754-2056
• Email: dan.michaeli@candidco.com
• Phone: 917-754-2056
• Email: dan.michaeli@candidco.com
• Phone: 917-754-2056
• Email: dan.michaeli@candidco.com
• Phone: 917-754-2056
• Email: dan.michaeli@candidco.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850004223024 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082560

FDA Product Code

• EIG: Retractor, All Types

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-28
• Device Publish Date: 2020-07-20

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• 00850004223116: Candid finished impression kit (Mesh Impression Tray + Kett Putty)
• 00850004223000: Candid finished impression kit (Old Tray + Kett Putty + Digital+toothbrush)
• 00850004223178: Candid finished impression kit (Mesh Impression Tray Low + Reg Impression Tray Up)
• 00850004223161: Candid finished impression kit (Old Tray + Kulz Putty + Digital)
• 00850004223024: August 2020 Promo
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