Ball Attachment Abutment

GUDID D824BATP4RC0

Ø3.5mm x L4.0mm, Conical Connection, Regular Platform

SURGIKOR, LLC

Basket endosteal dental implant, two-piece
Primary Device IDD824BATP4RC0
NIH Device Record Keye7cf9364-48e6-4a3f-8cb0-a2d8856c366b
Commercial Distribution StatusIn Commercial Distribution
Brand NameBall Attachment Abutment
Version Model NumberBATP4RC
Company DUNS080321629
Company NameSURGIKOR, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD824BATP4RC0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D824BATP4RC0]

Moist Heat or Steam Sterilization


[D824BATP4RC0]

Moist Heat or Steam Sterilization


[D824BATP4RC0]

Moist Heat or Steam Sterilization


[D824BATP4RC0]

Moist Heat or Steam Sterilization


[D824BATP4RC0]

Moist Heat or Steam Sterilization


[D824BATP4RC0]

Moist Heat or Steam Sterilization


[D824BATP4RC0]

Moist Heat or Steam Sterilization


[D824BATP4RC0]

Moist Heat or Steam Sterilization


[D824BATP4RC0]

Moist Heat or Steam Sterilization


[D824BATP4RC0]

Moist Heat or Steam Sterilization


[D824BATP4RC0]

Moist Heat or Steam Sterilization


[D824BATP4RC0]

Moist Heat or Steam Sterilization


[D824BATP4RC0]

Moist Heat or Steam Sterilization


[D824BATP4RC0]

Moist Heat or Steam Sterilization


[D824BATP4RC0]

Moist Heat or Steam Sterilization


[D824BATP4RC0]

Moist Heat or Steam Sterilization


[D824BATP4RC0]

Moist Heat or Steam Sterilization


[D824BATP4RC0]

Moist Heat or Steam Sterilization


[D824BATP4RC0]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-02-06

On-Brand Devices [Ball Attachment Abutment]

D824BATP6WC0Ø4.3mm x L6.0mm, Conical Connection, Wide Platform
D824BATP6RH0Ø3.75mm x L6.0mm, Hex Connection, Regular Platform
D824BATP6RC0Ø3.5mm x L6.0mm, Conical Connection, Regular Platform
D824BATP6NC0Ø3.0mm x L6.0mm, Conical Connection, Narrow Platform
D824BATP5WC0Ø4.3mm x L5.0mm, Conical Connection, Wide Platform
D824BATP5RH0Ø3.75mm x L5.0mm, Hex Connection, Regular Platform
D824BATP5RC0Ø3.5mm x L5.0mm, Conical Connection, Regular Platform
D824BATP5NC0Ø3.0mm x L5.0mm, Conical Connection, Narrow Platform
D824BATP4WC0Ø4.3mm x L4.0mm, Conical Connection, Wide Platform
D824BATP4RH0Ø3.75mm x L4.0mm, Hex Connection, Regular Platform
D824BATP4RC0Ø3.5mm x L4.0mm, Conical Connection, Regular Platform
D824BATP4NC0Ø3.0mm x L4.0mm, Conical Connection, Narrow Platform
D824BATP3WC0Ø4.3mm x L3.0mm, Conical Connection, Wide Platform
D824BATP3RH0Ø3.75mm x L3.0mm, Hex Connection, Regular Platform
D824BATP3RC0Ø3.5mm x L3.0mm, Conical Connection, Regular Platform
D824BATP3NC0Ø3.0mm x L3.0mm, Conical Connection, Narrow Platform
D824BATP2WC0Ø4.3mm x L2.0mm, Conical Connection, Wide Platform
D824BATP2RH0Ø3.75mm x L2.0mm, Hex Connection, Regular Platform
D824BATP2RC0Ø3.5mm x L2.0mm, Conical Connection, Regular Platform
D824BATP2NC0Ø3.0mm x L2.0mm, Conical Connection, Narrow Platform
D824BATP1WC0Ø4.3mm x L1.0mm, Conical Connection, Wide Platform
D824BATP1RH0Ø3.75mm x L1.0mm, Hex Connection, Regular Platform
D824BATP1RC0Ø3.5mm x L1.0mm, Conical Connection, Regular Platform
D824BATP1NC0Ø3.0mm x L1.0mm, Conical Connection, Narrow Platform

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