ESI ESI35010R

GUDID D890ESI35010R0

ESI Implant - Internal Hex 3.5mmx10mm RBM Surface

SPIRALTECH SUPERIOR DENTAL IMPLANTS, INC.

Screw endosteal dental implant, two-piece

• Primary Device ID: D890ESI35010R0
• NIH Device Record Key: 7ebfe3af-da5e-439c-ace6-7efbc2338b9c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ESI
• Version Model Number: ESI35010R
• Catalog Number: ESI35010R
• 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	D890ESI35010R0 [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: 2018-03-16

On-Brand Devices [ESI ]

• D980ESIC60013A0: ESI Implant Conical 6.0mmx13mm SLA Surface
• D890ESIC60015R0: ESI Implant - Conical 6.0mmx15mm RBM Surface
• D890ESIC60015A0: ESI Implant Conical 6.0mmx15mm SLA Surface
• D890ESIC60013R0: ESI Implant - Conical 6.0mmx13mm RBM Surface
• D890ESIC60011R0: ESI Implant - Conical 6.0mmx11.5mm RBM Surface
• D890ESIC60011A0: ESI Implant Conical 6.0mmx11.5mm SLA Surface
• D890ESIC60010R0: ESI Implant - Conical 6.0mmx10mm RBM Surface
• D890ESIC60010A0: ESI Implant Conical 6.0mmx10mm SLA Surface
• D890ESIC60008R0: ESI Implant - Conical 6.0mmx8mm RBM Surface
• D890ESIC60008A0: ESI Implant Conical 6.0mmx8mm SLA Surface
• D890ESIC50015R0: ESI Implant - Conical 5.0mmx15mm RBM Surface
• D890ESIC50015A0: ESI Implant Conical 5.0mmx15mm SLA Surface
• D890ESIC50013R0: ESI Implant - Conical 5.0mmx13mm RBM Surface
• D890ESIC50013A0: ESI Implant Conical 5.0mmx13mm SLA Surface
• D890ESIC50011R0: ESI Implant - Conical 5.0x11.5mm RBM Surface
• D890ESIC50011A0: ESI Implant Conical 5.0mmx11.5mm SLA Surface
• D890ESIC50010R0: ESI Implant - Conical 5.0mmx10mm RBM Surface
• D890ESIC50010A0: ESI Implant Conical 5.0mmx10mm SLA Surface
• D890ESIC50008R0: ESI Implant - Conical 5.0mmx8mm RBM Surface
• D890ESIC50008A0: ESI Implant Conical 5.0mmx8mm SLA Surface
• D890ESIC43015R0: ESI Implant - Conical 4.3mmx15mm RBM Surface
• D890ESIC43015A0: ESI Implant Conical 4.3mmx15mm SLA Surface
• D890ESIC43013R0: ESI Implant - Conical 4.3mmx13mm RBM Surface
• D890ESIC43013A0: ESI Implant Conical 4.3mmx13mm SLA Surface
• D890ESIC43011R0: ESI Implant - Conical 4.3mmx11.5mm RBM Surface
• D890ESIC43011A0: ESI Implant Conical 4.3mmx11.5mm SLA Surface
• D890ESIC43010R0: ESI Implant - Conical 4.3mmx10mm RBM Surface
• D890ESIC43010A0: ESI Implant Conical 4.3mmx10mm SLA Surface
• D890ESIC43008R0: ESI Implant - Conical 4.3mmx8mm RBM Surface
• D890ESIC43008A0: ESI Implant Conical 4.3mmx8mm SLA Surface
• D890ESIC35015R0: ESI Implant - Conical 3.5mmx15mm RBM Surface
• D890ESIC35015A0: ESI Implant Conical 3.5mmx15mm SLA Surface
• D890ESIC35013R0: ESI Implant - Conical 3.5mmx13mm RBM Surface
• D890ESIC35013A0: ESI Implant Conical 3.5mmx13mm SLA Surface
• D890ESIC35011R0: ESI Implant - Conical 3.5mmx11.5mm RBM surface
• D890ESIC35011A0: ESI Implant Conical 3.5mmx11.5mm SLA Surface
• D890ESIC35010R0: ESI Implant - Conical 3.5mmx10mm RBM Surface
• D890ESIC35010A0: ESI Implant Conical 3.5mmx10mm SLA Surface
• D890ESIC35008R0: ESI Implant - Conical 3.5mmx8mm RBM Surface
• D890ESIC35008A0: ESI Implant Conical 3.5mmx8mm SLA Surface
• D890ESIC30015R0: ESI Implant - Conical 3.0mmx15mm RBM Surface
• D890ESIC30015A0: ESI Implant Conical 3.0mmx15mm SLA Surface
• D890ESIC30013R0: ESI Implant - Conical 3.0mmx13mm RBM Surface
• D890ESIC30013A0: ESI Implant Conical 3.0mmx13mm SLA Surface
• D890ESIC30011R0: ESI Implant - Conical 3.0mmx11.5mm RBM Surface
• D890ESIC30011A0: ESI Implant Conical 3.0mmx11.5mm SLA Surface
• D890ESIC30010R0: ESI Implant - Conical 3.0mmx10mm RBM Surface
• D890ESIC30010A0: ESI Implant Conical 3.0mmx10mm SLA Surface
• D890ESI60015R0: ESI Implant - Internal Hex - 6.0mmx15mm RBM Surface
• D890ESI60015A0: ESI Implant Hex 6.0mmx15mm SLA Surface