solidex

Basic Information

• Brand Name: solidex
• Primary DI: D124NB43NEC0
• Version / Model: NB43NEC
• Company Name: Creo Dent Hudson Valley, Inc.
• Labeler DUNS: 071221112
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-19
• Public Version: 1
• Public Version Date: 2023-07-27
• Public Version Status: New
• Public Device Record Key: fb9b95b9-3873-4a83-afe0-2520b8f3476c

Device Description

Nonengaging Temporary Cylinder Compatible with Nobel Biocare Replace RP Implant Platform

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NHA	Abutment, Implant, Dental, Endosseous	Dental	872.3630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63349	Dental implant suprastructure, permanent, custom-made	A custom-made device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]; an abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure and is manufactured for a specific patient.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D124NB43NEC0	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K113738	000