Ultimate UL43008R

GUDID D890UL43008R0

Ultimate Implant Hex 4.3mmx8mm RBM surface

SPIRALTECH SUPERIOR DENTAL IMPLANTS, INC.

Screw endosteal dental implant, two-piece

• Primary Device ID: D890UL43008R0
• NIH Device Record Key: 8edfa2bf-983c-44d1-a065-4abab0f5cdd2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultimate
• Version Model Number: UL43008R
• Catalog Number: UL43008R
• Company DUNS: 086863437
• Company Name: SPIRALTECH SUPERIOR DENTAL IMPLANTS, INC.
• 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: false
• 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

Customer Support Contacts

• Phone: +13124407777
• Email: info@spiraltech.com
• Phone: +13124407777
• Email: info@spiraltech.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D890UL43008R0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170372

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: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-09

On-Brand Devices [Ultimate]

• D890ULC60015R0: Ultimate Implant - Conical 6.0mmx15mm RBM Surface
• D890ULC60015A0: Ultimate Implant Conical 6.0mmx15mm SLA Surface
• D890ULC60013R0: Ultimate Implant - Conical 6.0mmx13mm RBM surface
• D890ULC60013A0: Ultimate Implant Conical 3.0mmx13mm SLA Surface
• D890ULC60011R0: Ultimate Implant Conical 6.0mmx11.5mm RBM surface
• D890ULC60011A0: Ultimate Implant Conical 6.0mmx11.5mm SLA Surface
• D890ULC60010R0: Ultimate Implant - Conical 6.0mmx10mm RBM Surface
• D890ULC60010A0: Ultimate Implant Conical 6.0mmx10mm SLA Surface
• D890ULC60008R0: Ultimate Implant Conical 6.0mmx8mm RBM Surface
• D890ULC60008A0: Ultimate Implant Conical 6.0mmx8mm SLA Surface
• D890ULC50015R0: Ultimate Implant Conical 5.0mmx15mm RBM Surface
• D890ULC50015A0: Ultimate Implant Conical 5.0mmx15mm SLA Surface
• D890ULC50013R0: Ultimate Implant Conical 5.0mmx13mm RBM surface
• D890ULC50013A0: Ultimate Implant Conical 5.0mmx13mm SLA Surface
• D890ULC50011R0: Ultimate Implant Conical 5.0mmx11.5mm RBM surface
• D890ULC50011A0: Ultimate Implant Conical 5.0mmx11.5mm SLA Surface
• D890ULC50010R0: Ultimate Implant Conical 5.0mmx10mm RBM Surface
• D890ULC50010A0: Ultimate Implant Conical 5.0mmx10mm SLA Surface
• D890ULC50008R0: Ultimate Implant Conical 5.0mmx8mm RBM Surface
• D890ULC50008A0: Ultimate Implant Conical 5.0mmx8mm SLA Surface
• D890ULC43015R0: Ultimate Implant Conical 4.3mmx15mm RBM surface
• D890ULC43015A0: Ultimate Implant Conical 4.3mmx15mm SLA Surface
• D890ULC43013R0: Ultimate Implant Conical 4.3mmx13mm RBM Surface
• D890ULC43013A0: Ultimate Implant Conical 4.3mmx13mm SLA Surface
• D890ULC43011R0: Ultimate Implant Conical 4.3mmx11.5mm RBM Surface
• D890ULC43011A0: Ultimate Implant Conical 4.3mmx11.5mm SLA Surface
• D890ULC43010R0: Ultimate Implant - Conical 4.3mmx10mm RBM Surface
• D890ULC43010A0: Ultimate Implant Conical 4.3mmx10mm SLA Surface
• D890ULC43008R0: Ultimate Implant - Conical 4.3mmx8mm RBM Surface
• D890ULC43008A0: Ultimate Implant Conical 4.3mmx08mm SLA Surface
• D890ULC35015R0: Ultimate Implant Conical (3.5mm, 15mm) RBM Surface
• D890ULC35015A0: Ultimate Implant Conical 3.5mmx15mm SLA Surface
• D890ULC35013R0: Ultimate Implant Conical (3.5mm, 13mm) RBM Surface
• D890ULC35013A0: Ultimate Implant Conical 3.5mmx13mm SLA Surface
• D890ULC35011R0: Ultimate Implant Conical (3.5mm, 11mm) RBM Surface
• D890ULC35011A0: Ultimate Implant Conical 3.5mmx11.5mm SLA Surface
• D890ULC35010R0: Ultimate Implant Conical (3.5mm, 10mm) RBM Surface
• D890ULC35010A0: Ultimate Implant Conical 3.5mmx10mm SLA Surface
• D890ULC35008R0: Ultimate Implant Conical (3.5mm, 8mm) RBM Surface
• D890ULC35008A0: Ultimate Implant Conical 3.5mmx8mm SLA Surface
• D890ULC30015R0: Ultimate Implant Conical (3.0mm, 15mm) RBM Surface
• D890ULC30015A0: Ultimate Implant Conical 3.0mmx15mm SLA Surface
• D890ULC30013R0: Ultimate Implant Conical (3.0mm, 13mm) RBM Surface
• D890ULC30013A0: Ultimate Implant Conical 3.0mmx13mm SLA Surface
• D890ULC30011R0: Ultimate Implant Conical (3.0mm, 11mm) RBM Surface
• D890ULC30011A0: Ultimate Implant Conical 3.0mmx11.5mm SLA Surface
• D890ULC30010R0: Ultimate Implant Conical (3.0mm, 10mm) RBM Surface
• D890ULC30010A0: Ultimate Implant Conical 3.0mmx10mm SLA Surface
• D890UL60015R0: Ultimate Implant Hex 6.0mmx15mm RBM Surface
• D890UL60015A0: Ultimate Implant Hex 3.5mmx11.5mm SLA Surface