Trilor Arch

GUDID 08056099230745

Arch Height 5.5 mm.

BIOLOREN SRL

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08056099230745
• NIH Device Record Key: 6f6da60d-35e6-4f92-9293-0fe3b700fe60
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trilor Arch
• Version Model Number: TA 5.5
• Company DUNS: 428561679
• Company Name: BIOLOREN SRL
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08056099230745 [Primary]

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-11-08
• Device Publish Date: 2018-03-24

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