MTA-Flow Fast Set ZEN-MTA-FLOFST

GUDID 27540208000428

Endodontic repair cement - 0.25 g capsules

Zendo Direct AG

Endodontic filling/sealing material

• Primary Device ID: 27540208000428
• NIH Device Record Key: 5a2cd2d6-e3cf-4c1b-abc4-1b2f053eb112
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MTA-Flow Fast Set
• Version Model Number: ZEN-MTA-FLOFST
• Catalog Number: ZEN-MTA-FLOFST
• Company DUNS: 486717338
• Company Name: Zendo Direct AG
• Device Count: 2
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540208000424 [Unit of Use]
GS1	17540208000421 [Primary]
GS1	27540208000428 [Package]; Contains: 17540208000421; Package: Carton [1 Units]; In Commercial Distribution

FDA Product Code

• KIF: Resin, Root Canal Filling

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-11-23

Devices Manufactured by Zendo Direct AG

• 17540208000339 - Select Supratemp: 2018-05-07 Self cure temporary crown and bridge material - Shade: A3
• 17540208000131 - Select NanoFill: 2018-03-29 Low shrink low abrasion light cure nano filled composite - Caps; Shade A2
• 17540208000254 - Select Flow: 2018-03-29 Light cure easy flowable microhybrid composite - Needle Tubes; Shade A1
• 17540208000261 - Select Flow: 2018-03-29 Light cure easy flowable microhybrid composite - Needle Tubes; Shade A2
• 17540208000278 - Select Flow: 2018-03-29 Light cure easy flowable microhybrid composite - Needle Tubes; Shade A3
• 17540208000308 - Select NanoFill: 2018-03-29 Low shrink low abrasion light cure nano filled composite - Caps; Shade A1
• 27540208000398 - MTA Capsules: 2018-03-29 Endodontic repair cement - Universal; 0.3 g capsules
• 27540208000404 - MTA Firm- Normal Set: 2018-03-29 Endodontic repair cement - 0.25 g capsules