Candid Refinement Impression Kit

GUDID 00850004223987

Refinement Impression Kit (Medium Trays) Kett Putty Digital

CANDID CARE CO.

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.

• 00850004223345 - Candid Impression Kit: 2021-10-15 Candid finished impression kit (New Light Blue Tray + Kett Putty + Digital)
• 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)