MIMIC-3D Dental

GUDID 00817169020028

Bite Registration Impression Material 2/Pk RS

3D DENTAL DESIGNS AND DEVELOPMENT, LLC

Silicone dental impression material

• Primary Device ID: 00817169020028
• NIH Device Record Key: 4936937b-02f4-4b3b-b7ab-0afeb82b6fce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MIMIC-3D Dental
• Version Model Number: BR-R
• Company DUNS: 080194935
• Company Name: 3D DENTAL DESIGNS AND DEVELOPMENT, LLC
• Device Count: 1
• DM Exempt: true
• 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: false
• Lot Batch: true
• Serial Number: false
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817169020028 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K801380

FDA Product Code

• ELW: Material, Impression

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-09-16
• Device Publish Date: 2017-01-18

On-Brand Devices [MIMIC-3D Dental]

• 00817169021292: ALGINATE REGULAR SET
• 00817169021285: ALGINATE FAST SET
• 00817169021155: MIMIC REPLACMENT ALGINATE 50 ML 6/BOX
• 00817169020165: TEMPORARY CROWN & BRIDGE MATERIAL 76GM 10:1 5 TIPS A3
• 00817169020158: TEMPORARY CROWN & BRIDGE MATERIAL 76GM 10:1 5 TIPS A2
• 00817169020141: TEMPORARY CROWN & BRIDGE MATERIAL 76GM 10:1 5 TIPS A1/B1
• 00817169020134: VPS Vinyl Polysiloxane Impression Material 2/Pk Medium Body RS
• 00817169020127: VPS Vinyl Polysiloxane Impression Material 2/Pk Medium Body FS
• 00817169020110: MIMIC VPS PUTTY REGULAR SET
• 00817169020103: MIMIC VPS PUTTY FAST SET
• 00817169020097: VPS Vinyl Polysiloxane Impression Material 2/Pk Monophase RS
• 00817169020080: VPS Vinyl Polysiloxane Impression Material 2/Pk Monophase FS
• 00817169020073: VPS Vinyl Polysiloxane Impression Material 2/Pk Light Body RS
• 00817169020066: VPS Vinyl Polysiloxane Impression Material 2/Pk Light Body FS
• 00817169020059: VPS Vinyl Polysiloxane Impression Material 2/Pk Heavy Body RS
• 00817169020042: VPS Vinyl Polysiloxane Impression Material 2/Pk Heavy Body FS
• 00817169020035: Bite Registration Impression Material 2/Pk Super fast set Mint chocolate chip
• 00817169020028: Bite Registration Impression Material 2/Pk RS
• 00817169020011: Bite Registration Impression Material 2/Pk Fast Set