Analog for Printed Model PS IMPDA 3,25 60793

GUDID 05712821013781

The product consists of the Elos Accurate® Analog for Printed Models (Analog) manufactured in the biocompatible material titanium alloy grade 5 ELI (TiAl6V4 ELI).

Elos Medtech Pinol A/S

Dental implant analog

• Primary Device ID: 05712821013781
• NIH Device Record Key: f7466f82-4640-495d-8129-e80a8ed7f759
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Analog for Printed Model PS IMPDA 3,25
• Version Model Number: 60793
• Catalog Number: 60793
• Company DUNS: 306155953
• Company Name: Elos Medtech Pinol A/S
• 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: true
• Lot Batch: true
• Serial Number: false
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	05712821013781 [Primary]

FDA Product Code

• NDP: Accessories, Implant, Dental, Endosseous

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: 2024-08-07
• Device Publish Date: 2024-07-30

Devices Manufactured by Elos Medtech Pinol A/S

• 05712821012876 - Elos Accurate® Scan Body 22: 2025-01-30 The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the pa
• 05712821012920 - Elos Accurate® Scan Body 22: 2025-01-30 The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the pa
• 05712821012937 - Elos Accurate® Scan Body 22: 2025-01-30 The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the pa
• 05712821012944 - Elos Accurate® Scan Body 22: 2025-01-30 The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the pa
• 05712821012951 - Elos Accurate® Scan Body 22: 2025-01-30 The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the pa
• 05712821012968 - Elos Accurate® Scan Body 22: 2025-01-30 The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the pa
• 05712821012975 - Elos Accurate® Scan Body 22: 2025-01-30 The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the pa
• 05712821012982 - Elos Accurate® Scan Body 22: 2025-01-30 The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the pa