ROOTT

GUDID 00810149980046

Dental Implant, ROOTT R, D 4.2 mm, L 10 mm.

TRATE LLC

Screw endosteal dental implant, two-piece
Primary Device ID00810149980046
NIH Device Record Key71093f5f-ef76-4483-9510-0bb79f77537a
Commercial Distribution StatusIn Commercial Distribution
Brand NameROOTT
Version Model NumberR4210
Company DUNS129946338
Company NameTRATE LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Device Size Text, specify0
Length10 Millimeter
Device Size Text, specify0
Length10 Millimeter
Device Size Text, specify0
Length10 Millimeter
Device Size Text, specify0
Length10 Millimeter
Device Size Text, specify0
Length10 Millimeter
Device Size Text, specify0
Length10 Millimeter
Device Size Text, specify0
Length10 Millimeter
Device Size Text, specify0
Length10 Millimeter
Device Size Text, specify0
Length10 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS100810149980039 [Primary]
GS100810149980046 [Package]
Contains: 00810149980039
Package: [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-20
Device Publish Date2024-11-12

On-Brand Devices [ROOTT]

00810149980930Dental Implant, ROOTT R, D 3.5 mm, L 14 mm.
00810149980497Dental Implant, ROOTT R, D 3.5 mm, L 10 mm.
00810149980084Dental Implant, ROOTT R, D 3.5 mm, L 12 mm.
00810149980015Dental Implant, ROOTT R, D 3.5 mm, L 8 mm.
00810149980992Dental Implant, ROOTT R, D 4.8 mm, L 12 mm.
00810149980978Dental Implant, ROOTT R, D 4.8 mm, L 10 mm.
00810149980954Dental Implant, ROOTT R, D 4.2 mm, L 12 mm.
00810149980633Dental Implant, ROOTT R, D 3.8 mm, L 12 mm.
00810149980619Dental Implant, ROOTT R, D 5.5 mm, L 10 mm.
00810149980596Dental Implant, ROOTT R, D 5.5 mm, L 8 mm.
00810149980572Dental Implant, ROOTT R, D 4.8 mm, L 8 mm.
00810149980558Dental Implant, ROOTT R, D 4.2 mm, L 14 mm.
00810149980534Dental Implant, ROOTT R, D 4.2 mm, L 8 mm.
00810149980510Dental Implant, ROOTT R, D 3.8 mm, L 14 mm.
00810149980107Dental Implant, ROOTT R, D 3.8 mm, L 8 mm.
00810149980060Dental Implant, ROOTT R, D 3.8 mm, L 10 mm.
00810149980046Dental Implant, ROOTT R, D 4.2 mm, L 10 mm.
00810149981395Abutment, 15°, 1 mm, R.
00810149981456Abutment, 25°, 3 mm, R.
00810149981432Abutment, 25°, 1 mm, R.
00810149981388Abutment, 4 mm, R.
00810149981340Healing abutment, narrow, 6 mm, R.
00810149981326Healing abutment, narrow, 2 mm, R.
00810149981449Abutment, 25°, 2 mm, R.
00810149981357Abutment, 1 mm, R.
00810149981418Abutment, 15°, 3 mm, R.
00810149981296Healing abutment, 4 mm, R.
00810149981272Healing abutment, 1 mm, R.
00810149981425Abutment, 15°, 4 mm, R.
00810149981463Abutment, 25°, 4 mm, R.
00810149981333Healing abutment, narrow, 4 mm, R.
00810149981319Healing abutment, 6 mm, R.
00810149981371Abutment, 3 mm, R.
00810149981364Abutment, 2 mm, R.
00810149981401Abutment, 15°, 2 mm, R.
00810149981289Healing abutment, 2 mm, R.
00810149981302Healing abutment, 5 mm, R.

Trademark Results [ROOTT]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ROOTT
ROOTT
97832141 not registered Live/Pending
Restoring Our Own Through Transformation
2023-03-10
ROOTT
ROOTT
97832125 not registered Live/Pending
Restoring Our Own Through Transformation
2023-03-10

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