C-Tray Trans. Ext. Screw CTES

GUDID 00810157310972

C-Tray Trans. Extension Screw

Paragon Implant Mfg., LLC

Dental implant suprastructure, temporary, preformed, single-use
Primary Device ID00810157310972
NIH Device Record Key97ff1a2e-9e5d-44ab-8e55-caa6f5e7ae43
Commercial Distribution StatusIn Commercial Distribution
Brand NameC-Tray Trans. Ext. Screw
Version Model NumberCTES
Catalog NumberCTES
Company DUNS118698566
Company NameParagon Implant Mfg., 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 Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-855-649-4365
Emailinfo@paragon-implant.com
Phone1-855-649-4365
Emailinfo@paragon-implant.com
Phone1-855-649-4365
Emailinfo@paragon-implant.com
Phone1-855-649-4365
Emailinfo@paragon-implant.com
Phone1-855-649-4365
Emailinfo@paragon-implant.com
Phone1-855-649-4365
Emailinfo@paragon-implant.com
Phone1-855-649-4365
Emailinfo@paragon-implant.com
Phone1-855-649-4365
Emailinfo@paragon-implant.com
Phone1-855-649-4365
Emailinfo@paragon-implant.com
Phone1-855-649-4365
Emailinfo@paragon-implant.com
Phone1-855-649-4365
Emailinfo@paragon-implant.com
Phone1-855-649-4365
Emailinfo@paragon-implant.com
Phone1-855-649-4365
Emailinfo@paragon-implant.com

Device Dimensions

Outer Diameter3 Millimeter
Length12.5 Millimeter
Outer Diameter3 Millimeter
Length12.5 Millimeter
Outer Diameter3 Millimeter
Length12.5 Millimeter
Outer Diameter3 Millimeter
Length12.5 Millimeter
Outer Diameter3 Millimeter
Length12.5 Millimeter
Outer Diameter3 Millimeter
Length12.5 Millimeter
Outer Diameter3 Millimeter
Length12.5 Millimeter
Outer Diameter3 Millimeter
Length12.5 Millimeter
Outer Diameter3 Millimeter
Length12.5 Millimeter
Outer Diameter3 Millimeter
Length12.5 Millimeter
Outer Diameter3 Millimeter
Length12.5 Millimeter
Outer Diameter3 Millimeter
Length12.5 Millimeter
Outer Diameter3 Millimeter
Length12.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100810157310972 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810157310972]

Moist Heat or Steam Sterilization

[00810157310972]

Moist Heat or Steam Sterilization

[00810157310972]

Moist Heat or Steam Sterilization

[00810157310972]

Moist Heat or Steam Sterilization

[00810157310972]

Moist Heat or Steam Sterilization

[00810157310972]

Moist Heat or Steam Sterilization

[00810157310972]

Moist Heat or Steam Sterilization

[00810157310972]

Moist Heat or Steam Sterilization

[00810157310972]

Moist Heat or Steam Sterilization

[00810157310972]

Moist Heat or Steam Sterilization

[00810157310972]

Moist Heat or Steam Sterilization

[00810157310972]

Moist Heat or Steam Sterilization

[00810157310972]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-29
Device Publish Date2025-12-19

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00810157313164 - NizLoc Abutment2026-02-06 NizLoc Abut, 1-Piece, 4.0mmL-3.5mmP
00810157313171 - NizLoc Abutment2026-02-06 NizLoc Abut, 1-Piece, 5.0mmL-3.5mmP
00810157313188 - NizLoc Abutment2026-02-06 NizLoc Abut, 1-Piece, 1.0mmL-4.5mmP
00810157313195 - NizLoc Abutment2026-02-06 NizLoc Abut, 1-Piece, 2.0mmL-4.5mmP
00810157313201 - NizLoc Abutment2026-02-06 NizLoc Abut, 1-Piece, 3.0mmL-4.5mmP
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