Reflect RA3585C

GUDID 00817773024016

Reflect Rapid Fixture Ø3.5mm X 8.5L

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: 00817773024016
• NIH Device Record Key: 4fff1ab7-cbfa-41cc-91a0-f265bec66b18
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reflect
• Version Model Number: RA3585C
• Catalog Number: RA3585C
• 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

Device Dimensions

• Length: 8.5 Millimeter
• Length: 8.5 Millimeter
• Length: 8.5 Millimeter
• Length: 8.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817773024016 [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