3D Dental

Basic Information

• Brand Name: 3D Dental
• Primary DI: 00817169023975
• Version / Model: CI-DF10025
• Catalog Number: CI-DF10025
• Company Name: 3D DENTAL DESIGNS AND DEVELOPMENT, LLC
• Labeler DUNS: 080194935
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-29
• Public Version: 1
• Public Version Date: 2023-01-06
• Public Version Status: New
• Public Device Record Key: e7b0d25d-e7d7-4ded-9638-e6a7c1de718a

Device Description

Cavitron Type Insert 25K FSI-100

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
ELC	Scaler, Ultrasonic	Dental	872.4850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
49908	Borna disease virus neutralizing antibody IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of neutralizing antibodies to Borna disease virus in a clinical specimen, using Borna disease virus antigens of known specificity and a fluorescent immunoassay method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817169023975	GS1