FDA.reportPublic FDA data

NizPlant Imp. Center Screw

Primary DI
00810157313706
Brand
NizPlant Imp. Center Screw
Company
Paragon Implant Mfg., LLC
Model
NPCS
Catalog number
NPCS
Device description
NizPlant Imp. Center Screw (2 pcs)
Published
2026-01-30
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
00810157313706PrimaryGS10
00810157311672Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810157313706008101573137068101573137060810157313706
00810157311672008101573116728101573116720810157311672

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, temporary, preformed, single-useA prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length1.2Millimeter
Outer Diameter2.3Millimeter

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
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

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Primary DI, Brand, Company table
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