Candid Refinement Impression Kit

GUDID 00850004223987

Refinement Impression Kit (Medium Trays) Kett Putty Digital

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

• Primary Device ID: 00850004223987
• NIH Device Record Key: 5cb0dcfe-5ac3-428c-8728-a98073136078
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Candid Refinement Impression Kit
• Version Model Number: ITISK00001
• 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

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
• 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	00850004223987 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082560

FDA Product Code

• ELW: Material, Impression

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: 2021-04-08
• Device Publish Date: 2021-03-31

Devices Manufactured by CANDID CARE CO.

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• 00850004223567 - Candid Aligner: 2021-05-11 Candid Aligner System FA-0001
• 00850004223789 - Candid Impression Kit: 2021-05-04 Impression Kit (Medium Trays) Zest Putty Digital
• 00850004223987 - Candid Refinement Impression Kit: 2021-04-08Refinement Impression Kit (Medium Trays) Kett Putty Digital
• 00850004223987 - Candid Refinement Impression Kit: 2021-04-08 Refinement Impression Kit (Medium Trays) Kett Putty Digital
• 08500042230004 - Candid Aligner: 2020-10-12 Candid Aligner System FA-0001
• 00850004223222 - Candid Aligner: 2020-09-07 Candid Aligner System FA-0003
• 00850004223024 - Candid Impression Kit: 2020-07-28 August 2020 Promo
• 00850004223000 - Candid Impression Kit: 2020-04-13 Candid finished impression kit (Old Tray + Kett Putty + Digital+toothbrush)