CemPlant CP400

GUDID 00817773026096

CemPlant Implant Cement

INTEGRATED DENTAL SYSTEMS, LLC

Dental bone matrix implant, metallic

• Primary Device ID: 00817773026096
• NIH Device Record Key: 35619595-b547-45d5-8be6-17f8af8c134c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CemPlant
• Version Model Number: CP400
• Catalog Number: CP400
• Company DUNS: 079439145
• Company Name: INTEGRATED DENTAL SYSTEMS, LLC
• 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: true
• 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: 866-277-5662
• Email: ids@idsimplants.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817773026096 [Primary]

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-22
• Device Publish Date: 2020-05-14

Devices Manufactured by INTEGRATED DENTAL SYSTEMS, LLC

• 00817773026201 - Reflect Implant System: 2020-09-18 Reflect Certus 4.1 Healing Abut 6.0x4H
• 00817773026218 - Reflect Implant System: 2020-09-18 Reflect Certus 5.0 Healing Abut 5.6x4H
• 00817773022111 - Reflect Implant System: 2020-05-22 Reflect Certus 5.0 X 8.5
• 00817773022128 - Reflect Implant System: 2020-05-22 Reflect Certus 5.0 X 10
• 00817773022135 - Reflect Implant System: 2020-05-22 Reflect Certus 5.0 X 11.5
• 00817773022142 - Reflect Implant System: 2020-05-22 Reflect Certus 5.0 X 13
• 00817773023019 - Reflect Implant System: 2020-05-22 Reflect Recover 3.5mm X 08mmL
• 00817773023026 - Reflect Implant System: 2020-05-22 Reflect Recover 3.5mm X 10mmL