FDA.reportPublic FDA data

MUA Pros. Screw

Primary DI
00810157313102
Brand
MUA Pros. Screw
Company
Paragon Implant Mfg., LLC
Model
MPS-4
Catalog number
MPS-4
Device description
MUA Pros. Screw, M1.4 (4 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
00810157313102PrimaryGS10
00810157314246Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810157313102008101573131028101573131020810157313102
00810157314246008101573142468101573142460810157314246

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
Length1.5Millimeter
Outer Diameter2.1Millimeter

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
4
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
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
00810157314666TriActive ImplantTA5007TA50072026-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07899878068181NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068198NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068211NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068228NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068235NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068242NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068259NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07392532151156Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
07392532151163Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
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07392532192456Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
07392532192463Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
07392532192470Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
07392532192487Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
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07392532216343ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216350ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216367ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216374ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216381ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216398ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216404ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216411ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216428ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216435ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216442ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216459ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216466ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18