Anew Implantat System

GUDID 07350081495350

Dentatus Anew Implant, blister pack including 1 pc

Dentatus AB

Transgingival implant

• Primary Device ID: 07350081495350
• NIH Device Record Key: 9556bab9-b646-43df-a980-821ce0ae19ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anew Implantat System
• Version Model Number: ST-28L
• Company DUNS: 355803412
• Company Name: Dentatus AB
• 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: false
• Manufacturing Date: false
• 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: +46854650900
• Email: info@dentatus.se

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350081494797 [Primary]
GS1	07350081495350 [Package]; Contains: 07350081494797; Package: Implant pack [1 Units]; In Commercial Distribution
GS1	07350081495398 [Package]; Contains: 07350081494797; Package: Implant pack [2 Units]; In Commercial Distribution

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-07-04

Devices Manufactured by Dentatus AB

• 07350081494896 - IPR Lamineer Tips: 2024-11-01 2x Inter-Proximal Reduction Lamineer Tips for Profin Reciprocating Contra-Angles 0.25mm Blade Thickness, Single Sided, Left Side
• 07350081494902 - IPR Lamineer Tips: 2024-11-01 2x Inter-Proximal Reduction Lamineer Tips for Profin Reciprocating Contra-Angles 0.25mm Blade Thickness, Single Sided, Right Sid
• 07350081494919 - IPR Lamineer Tips: 2024-11-01 2x Inter-Proximal Reduction Lamineer Tips for Profin Reciprocating Contra-Angles 0.3mm Blade Thickness, Double Sided 50 Micron D
• 07350081494926 - IPR Lamineer Tips: 2024-11-01 2x Inter-Proximal Reduction Lamineer Tips for Profin Reciprocating Contra-Angles 0.4mm Blade Thickness, Double Sided 50 Micron D
• 07350081494933 - IPR Lamineer Tips: 2024-11-01 2x Inter-Proximal Reduction Lamineer Tips for Profin Reciprocating Contra-Angles 0.5mm Blade Thickness, Double Sided 50 Micron D
• 07350081495329 - Flex Lamineer Tips: 2024-11-01 2x Flex Lamineer Tips for Profin Reciprocating Contra-Angles Single Sided 75 Micron Diamond Coating
• 07350081495336 - Flex Lamineer Tips: 2024-11-01 2x Flex Lamineer Tips for Profin Reciprocating Contra-Angles Single Sided 50 Micron Diamond Coating
• 07350081495640 - IPR Lamineer Tips: 2024-11-01 5x Assorted Inter-Proximal Reduction Lamineer Tips for Profin Reciprocating Contra-Angles 1 of each of the following: 0.1mm Blad