Epikut ILHE 3585

GUDID 07899995243096

IMPLANTE HE Ø3,5 X 8,5MM

Sin Sistema de Implante Nacional S/A

Screw endosteal dental implant, one-piece

• Primary Device ID: 07899995243096
• NIH Device Record Key: 8daffb86-7c81-4823-a592-e5631bfaf413
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Epikut
• Version Model Number: ILHE 3585
• Catalog Number: ILHE 3585
• Company DUNS: 904569092
• Company Name: Sin Sistema de Implante Nacional S/A
• 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: true
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07899995243096 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211921

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-01-25
• Device Publish Date: 2022-01-17

On-Brand Devices [Epikut]

• 07899995294418: IMPLANTE CM Ø3,5 X 13,0MM
• 07899995294401: IMPLANTE CM Ø4,5 X 10,0MM
• 07899995294395: IMPLANTE CM Ø3,5 X 10,0MM
• 07899995294388: IMPLANTE CM Ø4,5 X 11,5MM
• 07899995275912: IMPLANTE CM Ø3,8 X 11,5MM
• 07899995274427: IMPLANTE CM Ø5,0 X 15,0MM
• 07899995273789: IMPLANTE CM Ø5,0 X 13,0MM
• 07899995273741: IMPLANTE CM Ø5,0 X 11,5MM
• 07899995273734: IMPLANTE CM Ø5,0 X 10,0MM
• 07899995273710: IMPLANTE CM Ø5,0 X 8,5MM
• 07899995273680: IMPLANTE CM Ø4,5 X 15,0MM
• 07899995273673: IMPLANTE CM Ø4,5 X 13,0MM
• 07899995273611: IMPLANTE CM Ø4,5 X 8,5MM
• 07899995273604: IMPLANTE CM Ø3,5 X 15,0MM
• 07899995273574: IMPLANTE CM Ø3,5 X 11,5MM
• 07899995273550: IMPLANTE CM Ø3,5 X 8,5MM
• 07899995267672: IMPLANTE CM Ø3,8 X 10,0MM
• 07899995264008: IMPLANTE CM Ø3,8 X 15,0MM
• 07899995253484: IMPLANTE CM Ø3,8 X 13,0MM
• 07899995251985: IMPLANTE CM Ø3,8 X 8,5MM
• 07899995244932: IMPLANTE HE Ø4,5 X 8,5MM
• 07899995244567: IMPLANTE HE Ø3,5 X 15,0MM
• 07899995244451: IMPLANTE HE Ø3,5 X 13,0MM
• 07899995244079: IMPLANTE HE Ø3,5 X 11,5MM
• 07899995243720: IMPLANTE HE Ø3,5 X 10,0MM
• 07899995243096: IMPLANTE HE Ø3,5 X 8,5MM
• 07899995241993: IMPLANTE HE Ø3,5 X 7,0MM
• 07899995241696: IMPLANTE HE Ø5,0 X 11,5MM
• 07899995240071: IMPLANTE HE Ø5,0 X 10,0MM
• 07899995239747: IMPLANTE HE Ø5,0 X 8,5MM
• 07899995239464: IMPLANTE HE Ø4,5 X 15,0MM
• 07899995238214: IMPLANTE HE Ø4,5 X 13,0MM
• 07899995237071: IMPLANTE HE Ø4,5 X 11,5MM
• 07899995237064: IMPLANTE HE Ø4,5 X 10,0MM
• 07899995234728: IMPLANTE HE Ø5,0 X 15,0MM
• 07899995234285: IMPLANTE HE Ø5,0 X 13,0MM