Solidex

GUDID D124SS65S0

Screw Compatible with Straumann Tissue Level WN Implant Platform

Creo Dent Hudson Valley, Inc.

Dental implant suprastructure, permanent, custom-made

• Primary Device ID: D124SS65S0
• NIH Device Record Key: a1181e45-4b3b-423d-949c-8e19438a2d15
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solidex
• Version Model Number: SS65S
• Company DUNS: 071221112
• Company Name: Creo Dent Hudson Valley, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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
HIBCC	D124SS65S0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202095

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[D124SS65S0]

Moist Heat or Steam Sterilization

[D124SS65S0]

Moist Heat or Steam Sterilization

[D124SS65S0]

Moist Heat or Steam Sterilization

[D124SS65S0]

Moist Heat or Steam Sterilization

[D124SS65S0]

Moist Heat or Steam Sterilization

[D124SS65S0]

Moist Heat or Steam Sterilization

[D124SS65S0]

Moist Heat or Steam Sterilization

[D124SS65S0]

Moist Heat or Steam Sterilization

[D124SS65S0]

Moist Heat or Steam Sterilization

[D124SS65S0]

Moist Heat or Steam Sterilization

[D124SS65S0]

Moist Heat or Steam Sterilization

[D124SS65S0]

Moist Heat or Steam Sterilization

[D124SS65S0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-29
• Device Publish Date: 2023-06-21

On-Brand Devices [Solidex]

• D1243I41BL0: 10mm Blank Compatible with Biomet 3i Certain Internal 4.1mm Implant Platform
• D124KP50BL0: 10mm Blank Compatible with Keystone Primaconnex WD Implant Platform
• D124KP500: 4.5mm Ti-Link Compatible with Keystone Primaconnex WD Implant Platform
• D124KP41BL0: 10mm Blank Compatible with Keystone Primaconnex RD Implant Platform
• D124KP410: 4.5mm Ti-Link Compatible with Keystone Primaconnex RD Implant Platform
• D124KP35S0: Screw Compatible with Keystone Primaconnex Implant Platform
• D124KP35BL0: 10mm Blank Compatible with Keystone Primaconnex SD Implant Platform
• D124KP35AS0: Angled Screw Compatible with Keystone Primaconnex SD Implant Platform
• D124KP350: 4.5mm Ti-Link Compatible with Keystone Primaconnex SD Implant Platform
• D124IA35S0: Screw Compatible with Implant Direct (InterActive) 3.0mm Implant Platform
• D124IA3560: 6mm Ti-Link Compatible with Implant Direct (InterActive) 3.0mm Implant Platform
• D124IA350: 4.5mm Ti-Link Compatible with Implant Direct (InterActive) 3.0mm Implant Platform
• D124DTRS0: Screw Compatible with Dentium SuperLine Regular 4.5mm Implant Platform
• D124DTRNE0: 6mm Nonengaging Ti-Link Compatible with Dentium SuperLine Regular 4.5mm Implant Platform
• D124DTRBL0: 10mm Blank Compatible with Dentium SuperLine Regular 4.5mm Implant Platform
• D124DTRB140: 14mm Blank Compatible with Dentium SuperLine Regular 4.5mm Implant Platform
• D124DTR60: 6mm Ti-Link Compatible with Dentium SuperLine Regular 4.5mm Implant Platform
• D124DTR0: 4.5mm Ti-Link Compatible with Dentium SuperLine Regular 4.5mm Implant Platform
• D124CL50SB0: Screw Compatible with Camlog 5.0mm Implant Platform
• D124CL50BL0: 10mm Blank Compatible with Camlog 5.0mm Implant Platform
• D124CL50AS0: Angled Screw Compatible with Camlog 5.0mm Implant Platform
• D124CL43BL0: 10mm Blank Compatible with Camlog 4.3mm Implant Platform
• D124CL430: 4.5mm Ti-Link Compatible with Camlog 4.3mm Implant Platform
• D124CL38BL0: 10mm Blank Compatible with Camlog 3.8mm Implant Platform
• D124CL380: 4.5mm Ti-Link Compatible with Camlog 3.8mm Implant Platform
• D124CL33S0: Screw Compatible with Camlog 3.3/3.8/4.3mm Implant Platform
• D124CL33BL0: 10mm Blank Compatible with Camlog 3.3mm Implant Platform
• D124CL33AS0: Angled Screw Compatible with Camlog 3.3mm Implant Platform
• D124CL330: 4.5mm Ti-Link Compatible with Camlog 3.3mm Implant Platform
• D124AS50S0: Screw Compatible with AstraTech Osseospeed TX 4.5/5.0mm Implant Platform
• D124AS50NE0: 6mm Nonengaging Ti-Link Compatible with AstraTech Osseospeed TX 4.5/5.0mm Implant Platform
• D124AS50BL0: 10mm Blank Compatible with AstraTech Osseospeed TX 4.5/5.0mm Implant Platform
• D124AS50B140: 14mm Blank Compatible with AstraTech Osseospeed TX 4.5/5.0mm Implant Platform
• D124AS50AS0: Angled Screw Compatible with AstraTech Osseospeed TX 4.5/5.0mm Implant Platform
• D124AS5060: 6mm Ti-Link Compatible with AstraTech Osseospeed TX 4.5/5.0mm Implant Platform
• D124AS500: 4.5mm Ti-Link Compatible with AstraTech Osseospeed TX 4.5/5.0mm Implant Platform
• D124AS40S0: Screw Compatible with AstraTech Osseospeed TX 3.5/4.0mm Implant Platform
• D124AS40NE0: 6mm Nonengaging Ti-Link Compatible with AstraTech Osseospeed TX 3.5/4.0mm Implant Platform
• D124AS40BL0: 10mm Blank Compatible with AstraTech Osseospeed TX 3.5/4.0mm Implant Platform
• D124AS40B140: 14mm Blank Compatible with AstraTech Osseospeed TX 3.5/4.0mm Implant Platform
• D124AS40AS0: Angled Screw Compatible with AstraTech Osseospeed TX 3.5/4.0mm Implant Platform
• D124AS4060: 6mm Ti-Link Compatible with AstraTech Osseospeed TX 3.5/4.0mm Implant Platform
• D124AS400: 4.5mm Ti-Link Compatible with AstraTech Osseospeed TX 3.5/4.0mm Implant Platform
• D124AS30S0: Screw Compatible with AstraTech Osseospeed TX 3.0mm Implant Platform
• D124AS30NE0: 6mm Nonengaging Ti-Link Compatible with AstraTech Osseospeed TX 3.0mm Implant Platform
• D124AS30BL0: 10mm Blank Compatible with AstraTech Osseospeed TX 3.0mm Implant Platform
• D124AS30B140: 14mm Blank Compatible with AstraTech Osseospeed TX 3.0mm Implant Platform
• D124AS30AS0: Angled Screw Compatible with AstraTech Osseospeed TX 3.0mm Implant Platform
• D124AS3060: 6mm Ti-Link Compatible with AstraTech Osseospeed TX 3.0mm Implant Platform
• D124AS300: 4.5mm Ti-Link Compatible with AstraTech Osseospeed TX 3.0mm Implant Platform