Ext. Cont. Straight Abutment XTSA-1R

GUDID 00810157312389

Ext. Str. Abut, 4.8mmD-0.25mmL-4.8mmP

Paragon Implant Mfg., LLC

Dental implant suprastructure, permanent, preformed
Primary Device ID00810157312389
NIH Device Record Key60a6bab0-0b5e-4548-a6f9-da103f5c4cb5
Commercial Distribution StatusIn Commercial Distribution
Brand NameExt. Cont. Straight Abutment
Version Model NumberXTSA-1R
Catalog NumberXTSA-1R
Company DUNS118698566
Company NameParagon Implant Mfg., 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

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

Device Dimensions

Outer Diameter4.8 Millimeter
Length0.25 Millimeter
Outer Diameter4.8 Millimeter
Length0.25 Millimeter
Outer Diameter4.8 Millimeter
Length0.25 Millimeter
Outer Diameter4.8 Millimeter
Length0.25 Millimeter
Outer Diameter4.8 Millimeter
Length0.25 Millimeter
Outer Diameter4.8 Millimeter
Length0.25 Millimeter
Outer Diameter4.8 Millimeter
Length0.25 Millimeter
Outer Diameter4.8 Millimeter
Length0.25 Millimeter
Outer Diameter4.8 Millimeter
Length0.25 Millimeter
Outer Diameter4.8 Millimeter
Length0.25 Millimeter
Outer Diameter4.8 Millimeter
Length0.25 Millimeter
Outer Diameter4.8 Millimeter
Length0.25 Millimeter
Outer Diameter4.8 Millimeter
Length0.25 Millimeter
Outer Diameter4.8 Millimeter
Length0.25 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100810157312389 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810157312389]

Moist Heat or Steam Sterilization

[00810157312389]

Moist Heat or Steam Sterilization

[00810157312389]

Moist Heat or Steam Sterilization

[00810157312389]

Moist Heat or Steam Sterilization

[00810157312389]

Moist Heat or Steam Sterilization

[00810157312389]

Moist Heat or Steam Sterilization

[00810157312389]

Moist Heat or Steam Sterilization

[00810157312389]

Moist Heat or Steam Sterilization

[00810157312389]

Moist Heat or Steam Sterilization

[00810157312389]

Moist Heat or Steam Sterilization

[00810157312389]

Moist Heat or Steam Sterilization

[00810157312389]

Moist Heat or Steam Sterilization

[00810157312389]

Moist Heat or Steam Sterilization

[00810157312389]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-01-14
Device Publish Date2026-01-06

Devices Manufactured by Paragon Implant Mfg., LLC

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00810157313140 - NizLoc Abutment2026-02-06 NizLoc Abut, 1-Piece, 2.0mmL-3.5mmP
00810157313157 - NizLoc Abutment2026-02-06 NizLoc Abut, 1-Piece, 3.0mmL-3.5mmP
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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