FDA.reportPublic FDA data

NizPlant™ Implant

Primary DI
00810157313492
Brand
NizPlant™ Implant
Company
Paragon Implant Mfg., LLC
Model
NP4211
Catalog number
NP4211
Device description
NizPlant Imp. 4.2mmD-11mmL-3.9mmP
Published
2026-01-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

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
00810157313492PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810157313492008101573134928101573134920810157313492

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant systemA collection of devices designed for the surgical placement of a dental implant into alveolar and/ or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length11Millimeter
Outer Diameter4.2Millimeter

Sterilization Methods#

Method table
Method

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
Expiration date on label
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
08800070228951ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070228968ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070228975ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070228982ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070228999ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229002ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229019ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229026ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229033ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229040ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229057ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229064ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229071ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229088ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229095ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229101ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229118ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070203156ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203217ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203224ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203231ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203248ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203255ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203262ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203279ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203286ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203293ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203309ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203316ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203323ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04