0817773021046 RS3513C

GUDID 00817773021046

Reflect Aspire 3.5x13

INTEGRATED DENTAL SYSTEMS, LLC

Dental bone matrix implant, metallic Dental bone matrix implant, metallic Dental bone matrix implant, metallic Dental bone matrix implant, metallic

• Primary Device ID: 00817773021046
• NIH Device Record Key: a3c881b7-86cc-4ed4-a276-24e971d9111f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 0817773021046
• Version Model Number: RS3513C
• Catalog Number: RS3513C
• 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
• Phone: 866-277-5662
• Email: ids@idsimplants.com
• Phone: 866-277-5662
• Email: ids@idsimplants.com
• Phone: 866-277-5662
• Email: ids@idsimplants.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817773021046 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180924

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: 2020-05-21
• Device Publish Date: 2020-05-13

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