Epikut Plus ILHE 4507N

GUDID 07899995231994

IMPLANTE HE Ø4,5 X 7,0MM

Sin Sistema de Implante Nacional S/A

Screw endosteal dental implant, one-piece

• Primary Device ID: 07899995231994
• NIH Device Record Key: 7f03795b-59f0-4b06-9beb-a36c77ee6656
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Epikut Plus
• Version Model Number: ILHE 4507N
• Catalog Number: ILHE 4507N
• 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	07899995231994 [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 Plus]

• 07899995299956: IMPLANTE CM Ø3,5 X 10,0MM
• 07899995296887: IMPLANTE CM Ø3,5 X 8,5MM
• 07899995275110: IMPLANTE CM Ø3,8 X 10,0MM
• 07899995273659: IMPLANTE HE Ø5,0 X 15,0MM
• 07899995273635: IMPLANTE HE Ø5,0 X 13,0MM
• 07899995273581: IMPLANTE HE Ø5,0 X 11,5MM
• 07899995273567: IMPLANTE HE Ø5,0 X 10,0MM
• 07899995273512: IMPLANTE CM Ø4,5 X 8,5MM
• 07899995267627: IMPLANTE CM Ø3,8 X 15,0MM
• 07899995265609: IMPLANTE CM Ø3,8 X 11,5MM
• 07899995251527: IMPLANTE CM Ø3,8 X 13,0MM
• 07899995250186: IMPLANTE CM Ø3,8 X 8,5MM
• 07899995249074: IMPLANTE CM Ø3,5 X 15,0MM
• 07899995248732: IMPLANTE CM Ø3,5 X 13,0MM
• 07899995248213: IMPLANTE CM Ø3,5 X 11,5MM
• 07899995247933: IMPLANTE CM Ø4,5 X 15,0MM
• 07899995246851: IMPLANTE CM Ø4,5 X 10,0MM
• 07899995246431: IMPLANTE CM Ø5,0 X 8,5MM
• 07899995246165: IMPLANTE CM Ø4,5 X 11,5MM
• 07899995245830: IMPLANTE CM Ø5,0 X 10,0MM
• 07899995245311: IMPLANTE CM Ø4,5 X 13,0MM
• 07899995245274: IMPLANTE CM Ø5,0 X 11,5MM
• 07899995245083: IMPLANTE CM Ø5,0 X 13,0MM
• 07899995245045: IMPLANTE CM Ø5,0 X 15,0MM
• 07899995237002: IMPLANTE HE Ø3,5 X 10,0MM
• 07899995236043: IMPLANTE HE Ø3,5 X 8,5MM
• 07899995235862: IMPLANTE HE Ø3,5 X 7,0MM
• 07899995233516: IMPLANTE HE Ø4,5 X 13,0MM
• 07899995233462: IMPLANTE HE Ø4,5 X 11,5MM
• 07899995233066: IMPLANTE HE Ø4,5 X 10,0MM
• 07899995232489: IMPLANTE HE Ø4,5 X 8,5MM
• 07899995231994: IMPLANTE HE Ø4,5 X 7,0MM
• 07899995231765: IMPLANTE HE Ø3,5 X 15,0MM
• 07899995230126: IMPLANTE HE Ø3,5 X 13,0MM
• 07899995229533: IMPLANTE HE Ø3,5 X 11,5MM
• 07899995229359: IMPLANTE HE Ø5,0 X 8,5MM
• 07899995229328: IMPLANTE HE Ø4,5 X 15,0MM