Trilor Arch

GUDID 08056099232435

Arch Kit Pink (3,5 mm. / 5,5 mm. / 7,5 mm.)

BIOLOREN SRL

Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08056099232435
• NIH Device Record Key: 4d8f75aa-6cf6-4822-8c2e-9967e4c17f2f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trilor Arch
• Version Model Number: TAKITPP
• Company DUNS: 428561679
• Company Name: BIOLOREN SRL
• Device Count: 3
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08056099232435 [Primary]
GS1	18056099232432 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173643

FDA Product Code

• EBF: Material, Tooth Shade, Resin

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: 2021-09-21
• Device Publish Date: 2021-09-13

On-Brand Devices [Trilor Arch]

• 08056099230752: Arch Height 7,5 mm.
• 08056099230745: Arch Height 5.5 mm.
• 08056099230738: Arch Heigh 3.5 mm
• 08056099232442: Arch Kit New Pink (5,5 mm. / 7,5 mm.)
• 08056099232435: Arch Kit Pink (3,5 mm. / 5,5 mm. / 7,5 mm.)
• 08056099232428: Arch Height 7,5 mm. New Pink
• 08056099232411: Arch Height 7,5 mm. Pink
• 08056099232404: Arch Height 5,5 mm. New Pink
• 08056099232398: Arch Height 5.5 mm. Pink
• 08056099232381: Arch Height 3.5 mm. Pink