Neodent

Basic Information

• Brand Name: Neodent
• Primary DI: 07899878028970
• Version / Model: 106.228
• Catalog Number: 106.228
• Company Name: JJGC Indústria e Comércio de Materiais Dentários S/A.
• Labeler DUNS: 906713888
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-10
• Public Version: 2
• Public Version Date: 2023-12-21
• Public Version Status: Update
• Public Device Record Key: 621af752-b2b0-4913-b46d-4642ee05c520

Device Description

GM CUSTOMIZABLE HEALING ABUTMENT

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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

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
44880	Dental implant suprastructure, temporary, preformed, single-use	A prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07899878028970	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K180536	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	7.0	Millimeter
Device Size Text, specify			Gingival Height 2.5 mm

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: High: 40 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Protect from Sunlight