FDA.reportPublic FDA data

Implant Analog

Primary DI
00810157311092
Brand
Implant Analog
Company
Paragon Implant Mfg., LLC
Model
IA45
Catalog number
IA45
Device description
Implant Analog, 4.5mmP (2 pcs)
Published
2026-01-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810157311092PrimaryGS10
00810157313720Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810157311092008101573110928101573110920810157311092
00810157313720008101573137208101573137200810157313720

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant analogA device intended to be used as a copy of a dental implant, for a dental laboratory working model, to duplicate the location and restorative platform orientation of the final dental implant; it is not intended for intraoral use. It is a rod-like device made of metal [e.g., titanium (Ti)]. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length14.5Millimeter
Outer Diameter4.7Millimeter

Contacts#

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

Regulatory Flags#

DUNS number
118698566
Device count
2
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
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
07899995226457SLEEVE FOR SURGICAL GUIDEØ5.1MM OPENSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995226464SLEEVE FOR SURGICAL GUIDE Ø5.1MM OPENSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995226471SLEEVE FOR SURGICAL GUIDE Ø3.9MM OPENSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995226488SLEEVE FOR SURGICAL GUIDE Ø3.9MM OPENSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995226495SLEEVE FOR SURGICAL GUIDE Ø5.1MMSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995226501SLEEVE FOR SURGICAL GUIDE Ø5.1MMSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995226518SLEEVE FOR SURGICAL GUIDE Ø3.9MMSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995226525SLEEVE FOR SURGICAL GUIDE Ø3.9MMSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995226532SLEEVE FOR FIXER GUIDE Ø2.0MM PALATALSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995226556SLEEVE FOR FIXER GUIDE Ø2.0MM PALATALSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995226563SLEEVE FOR FIXER GUIDE Ø1.4MMSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234346DRIVER RATCHET IMP. MT16° GUIDEDSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234353DRIVER RATCHET IMP. MT16° GUIDED NARROWSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234360DRIVER HANDP. IMP. MT16° GUIDEDSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234377DRIVER HANDP. IMP. MT16° GUIDED NARROWSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234391ANALOG REVERSE MICRO MINI ABUT.Sin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234407ANALOG REVERSE MINI ABUT.Sin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234414ANALOG REVERSE CM11.5°Sin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234421ANALOG REVERSE MT16°Sin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234438ANALOG REVERSE ABUT MULT.Sin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234445ANALOG HYBRIDO ABUT UNIV Ø4.5X6MMSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234452ANALOG HYBRIDO ABUT UNIV Ø4.5X4MMSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234469ANALOG HYBRIDO ABUT UNIV Ø3.3X6MMSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234476ANALOG HYBRIDO ABUT UNIV Ø3.3X4MMSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234490ANALOG HYBRID MICRO MINI ABUT.Sin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234506ANALOG HYBRID 4.5IHSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234513ANALOG HYBRID 3.5IHSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234520ANALOG HYBRID 3.0IHSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234537ANALOG HYBRID HI Ø4.5MMSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234544ANALOG HYBRID HI Ø3.8MMSin Sistema de Implante Nacional S/ANDP2026-10-29