Anew Surgical and Prosthetic Instrumentation Kit SK-3

GUDID 07350081494858

ANEW Surgical and Prosthetic Instrumentation Kit - Drill System 2 2 - 1.4 Center Point Pilot Drills (1 Short & 1 Long) (=1.8 Impl. Diam.) - Drill Syst

Dentatus AB

Dental implant suprastructure kit

• Primary Device ID: 07350081494858
• NIH Device Record Key: 75e51766-50a9-44ec-8ab0-5d429607f6aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anew Surgical and Prosthetic Instrumentation Kit
• Version Model Number: SK-3
• Catalog Number: SK-3
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: +12124811010
• Email: dentatus@dentatus.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350081494858 [Primary]

FDA Product Code

• NDP: Accessories, Implant, Dental, Endosseous

Sterilization

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

[07350081494858]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-08-10

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