FDA.reportPublic FDA data

Ext. Universal Fixation Screw

Primary DI
00810157312181
Brand
Ext. Universal Fixation Screw
Company
Paragon Implant Mfg., LLC
Model
XTFS
Catalog number
XTFS
Device description
Ext. Univ. Fix. Screw (2 pcs)
Published
2026-01-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251938000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251938000GEN5 and GEN5+ Dental Implant SystemParagon Implant Mfg., LLC2025-10-30DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810157312181PrimaryGS10
00810157314413Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810157312181008101573121818101573121810810157312181
00810157314413008101573144138101573144130810157314413

GMDN Terms#

Term, Definition table
TermDefinition
Dental prosthesis/implant abutment screwA device intended to be used short- or long-term to attach a dental implant abutment and/or prosthesis (e.g., crown, bridge) to a dental implant during dental restorative procedures. It is made of metal [e.g., titanium (Ti)] and consists of a rod-like fastener inserted through the abutment/prosthesis. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length4.1Millimeter
Outer Diameter2.2Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-855-649-4365info@paragon-implant.com

Regulatory Flags#

DUNS number
118698566
Device count
2
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810157315229Basic Surgical KitBSKBSK2026-06-02
00810157311573NizLoc Abutment for NizPlant ImplantNPNL-2NPNL-22026-02-24
00810157313331NizPlant Insertion ToolNPIT-LNPIT-L2026-02-13
00810157313775NizPlant Insertion ToolNPIT-SNPIT-S2026-02-13
00810157313300NizPlant Implant ToolNPITNPIT2026-02-12
00810157311566NizPlant TransferNPT-NRNPT-NR2026-01-30
00810157313706NizPlant Imp. Center ScrewNPCSNPCS2026-01-30
00810157313751NizPlant Fixation Screw NPFSXSNPFSXS2026-01-30
00810157314130Ext. NizLoc Abutment ScrewXTNL-0XTNL-02026-01-30
00810157314147Ext. NizLoc Abutment ScrewXTNL-1XTNL-12026-01-30
00810157314154Ext. NizLoc Abutment ScrewXTNL-2XTNL-22026-01-30
00810157313133NizLoc AbutmentNL35-11NL35-112026-01-29
00810157313140NizLoc AbutmentNL35-12NL35-122026-01-29
00810157313157NizLoc AbutmentNL35-13NL35-132026-01-29
00810157313164NizLoc AbutmentNL35-14NL35-142026-01-29
00810157313171NizLoc AbutmentNL35-15NL35-152026-01-29
00810157313188NizLoc AbutmentNL45-11NL45-112026-01-29
00810157313195NizLoc AbutmentNL45-12NL45-122026-01-29
00810157313201NizLoc AbutmentNL45-13NL45-132026-01-29
00810157313218NizLoc AbutmentNL45-14NL45-142026-01-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842448118561TITAN IMPLANTS INC.TITAN IMPLANT INCNHA2026-09-06
00810125998713ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998720ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998737ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998744ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998751ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998768ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998775ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998782ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998799ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998805ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998812ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998829ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998836ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998843ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998850ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998867ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998874ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998881ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998898ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998904ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998911ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998928ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998935ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998942ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998959EK Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998966EK Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998973EK Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998980EK Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998997EK Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04