Trilor Arch

GUDID 08056099232404

Arch Height 5,5 mm. New Pink

BIOLOREN SRL

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08056099232404
• NIH Device Record Key: fbcfda99-1349-4203-82d2-5246cb62b5d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trilor Arch
• Version Model Number: TA5.5NWPP
• Company DUNS: 428561679
• Company Name: BIOLOREN SRL
• 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: 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 Dimensions

• Height: 5.5 Millimeter
• Height: 5.5 Millimeter
• Height: 5.5 Millimeter
• Height: 5.5 Millimeter
• Height: 5.5 Millimeter
• Height: 5.5 Millimeter
• Height: 5.5 Millimeter
• Height: 5.5 Millimeter
• Height: 5.5 Millimeter
• Height: 5.5 Millimeter
• Height: 5.5 Millimeter
• Height: 5.5 Millimeter
• Height: 5.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	08056099232404 [Primary]
GS1	18056099232401 [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