FDA.reportPublic FDA data

NizPlant Fixation Screw

Primary DI
00810157313744
Brand
NizPlant Fixation Screw
Company
Paragon Implant Mfg., LLC
Model
NPFSL
Catalog number
NPFSL
Device description
NizPlant Fix. Screw, Long
Published
2026-01-08
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
K250476000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250476000NizPlant Dental Implant SystemParagon Implant Mfg., LLC2025-12-23DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810157313744PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810157313744008101573137448101573137440810157313744

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
Length15.8Millimeter
Outer Diameter3Millimeter

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
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810157315762MUA PEEK Comfort CapMACC-4MACC-42026-10-09
00810157315724Friction-Fit Removal ToolFFRT1.6FFRT1.62026-09-22
00810157315731Friction-Fit Removal ToolFFRT2.0FFRT2.02026-09-22
00810157313867TriActive ImplantTA3208TA32082026-09-21
00810157314048TriActive ImplantTA3210TA32102026-09-21
00810157314161TriActive ImplantTA3211TA32112026-09-21
00810157314208TriActive ImplantTA3213TA32132026-09-21
00810157314536TriActive ImplantTA3215TA32152026-09-21
00810157314543TriActive ImplantTA3707TA37072026-09-21
00810157314550TriActive ImplantTA3708TA37082026-09-21
00810157314567TriActive ImplantTA3710TA37102026-09-21
00810157314574TriActive ImplantTA3711TA37112026-09-21
00810157314581TriActive ImplantTA3713TA37132026-09-21
00810157314598TriActive ImplantTA3715TA37152026-09-21
00810157314604TriActive ImplantTA4307TA43072026-09-21
00810157314611TriActive ImplantTA4308TA43082026-09-21
00810157314628TriActive ImplantTA4310TA43102026-09-21
00810157314635TriActive ImplantTA4311TA43112026-09-21
00810157314642TriActive ImplantTA4313TA43132026-09-21
00810157314659TriActive ImplantTA43152026-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
088000968494378plant Implant System8dent Inc.NHA2026-10-16
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088000968496738plant Implant System8dent Inc.NHA2026-10-16
088000968499498plant Implant System8dent Inc.NHA2026-10-16
088000968499638plant Implant System8dent Inc.NHA2026-10-16
088000968501438plant Implant System8dent Inc.NHA2026-10-16
088000968501508plant Implant System8dent Inc.NHA2026-10-16
088000968501678plant Implant System8dent Inc.NHA2026-10-16
088000968501818plant Implant System8dent Inc.NHA2026-10-16
088000968501988plant Implant System8dent Inc.NHA2026-10-16
088000968513248plant Implant System8dent Inc.NHA2026-10-16
088000968513318plant Implant System8dent Inc.NHA2026-10-16
088000968513488plant Implant System8dent Inc.NHA2026-10-16
088000968513558plant Implant System8dent Inc.NHA2026-10-16
088000968513628plant Implant System8dent Inc.NHA2026-10-16
088000968513798plant Implant System8dent Inc.NHA2026-10-16
088000968513868plant Implant System8dent Inc.NHA2026-10-16
088000968513938plant Implant System8dent Inc.NHA2026-10-16
088000968514308plant Implant System8dent Inc.NHA2026-10-16
088000968514478plant Implant System8dent Inc.NHA2026-10-16
088000968514548plant Implant System8dent Inc.NHA2026-10-16
088000968515088plant Implant System8dent Inc.NHA2026-10-16
088000968515918plant Implant System8dent Inc.NHA2026-10-16
088000968516458plant Implant System8dent Inc.NHA2026-10-16
088000968516528plant Implant System8dent Inc.NHA2026-10-16
088000968516698plant Implant System8dent Inc.NHA2026-10-16
088000968581328plant Implant System8dent Inc.NHA2026-10-16
088000968586518plant Implant System8dent Inc.NHA2026-10-16
088000968586688plant Implant System8dent Inc.NHA2026-10-16