Candid Impression Kit

GUDID 00850004223109

Candid finished impression kit (Mesh Impression Tray)

CANDID CARE CO.

Silicone dental impression material

• Primary Device ID: 00850004223109
• NIH Device Record Key: 89be0114-928b-47bc-a72c-9e5aaa8955f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Candid Impression Kit
• Version Model Number: IKMESHFINISHED00001
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• 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: 917-754-2056
• Email: dan.michaeli@candidco.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Celsius and 23 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850004223109 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K821221

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: 2019-06-20
• Device Publish Date: 2019-06-12

On-Brand Devices [Candid Impression Kit]

• 00850004223017: Candid finished impression kit
• 00850004223109: Candid finished impression kit (Mesh Impression Tray)
• 00850004223123: Candid finished impression kit (Old Tray + Kett Putty + Digital)
• 00850004223185: Candid finished impression kit (Old Tray + Kett Putty + Digital)
• 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
• 00850004223789: Impression Kit (Medium Trays) Zest Putty Digital
• 00850004223345: Candid finished impression kit (New Light Blue Tray + Kett Putty + Digital)