CamX Elara

GUDID E247J21101

DÜRR DENTAL SE

Intraoral camera Intraoral camera Intraoral camera Intraoral camera Intraoral camera Intraoral camera Intraoral camera Intraoral camera Intraoral camera Intraoral camera Intraoral camera Intraoral camera

• Primary Device ID: E247J21101
• NIH Device Record Key: 9797993a-8cf9-4820-bd9c-1619e47c8353
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CamX Elara
• Version Model Number: J2110
• Company DUNS: 315563684
• Company Name: DÜRR DENTAL SE
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Serial Number: true
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E247J21101 [Primary]

FDA Product Code

• NRD: Unit, Operative Dental, Accessories

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: 2022-03-14
• Device Publish Date: 2022-03-04

Devices Manufactured by DÜRR DENTAL SE

• E247732480 - ScanX Barrier Envelope, 100 Pcs, Size 0: 2023-03-07 Light protection covers for image plates (used with the ScanX image plate scanners).
• E247732482 - ScanX Barrier Envelope, 300 Pcs, Size 2: 2023-03-07 Light protection covers for image plates (used with the ScanX image plate scanners).
• E247G8800 - ScanX Swift 2.0: 2023-03-07 Dental Image Plate Scanner
• E247G8900 - ScanX Swift View 2.0: 2023-03-07 Dental Image Plate Scanner
• E247E7300A10 - VisionX: 2022-04-04 VisionX version 3.0.x
• E247A78610 - ProVecta 3D Prime Ceph: 2022-03-14 X-Ray System
• E247J21101 - CamX Elara: 2022-03-14
• E247J21101 - CamX Elara: 2022-03-14
• E247J27111 - CamX Cam Interchangeable Head: 2022-03-14