ROOTT

Basic Information

• Brand Name: ROOTT
• Primary DI: 00810149980985
• Version / Model: R4812
• Company Name: TRATE LLC
• Labeler DUNS: 129946338
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-11-12
• Public Version: 1
• Public Version Date: 2024-11-20
• Public Version Status: New
• Public Device Record Key: 4b7afcb2-6edd-4ed1-96aa-5bf547b335ff

Device Description

Dental Implant, ROOTT R, D 4.8 mm, L 12 mm.

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: 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
DZE	Implant, Endosseous, Root-Form	Dental	872.3640	2
NHA	Abutment, Implant, Dental, Endosseous	Dental	872.3630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55849	Screw endosteal dental implant, two-piece	A sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00810149980992	GS1		5	In Commercial Distribution
Primary	00810149980985	GS1

Premarket Submissions

Submission Number	Supplement Number
K220022	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Diameter 4.8 mm
Length	12	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry
• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight