FDA.reportPublic FDA data

IPD

Primary DI
08435566640315
Brand
IPD
Company
IMPLANT PROTESIS DENTAL 2004 SL
Model
TT
Catalog number
IPD/EB-TR-00/X
Device description
IPDmilled Ti Screw Ø 4,2
Published
2026-01-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
NHAAbutment, Implant, Dental, Endosseous
PNPDental Abutment Design Software For Dental Laboratory

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2
PNPDental Abutment Design Software For Dental LaboratoryDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253253000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253253000IPDmilled BlanksImplant Protesis Dental 2004, S.L.2026-01-22NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08435566640315PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08435566640315084355666403158435566640315

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
467871518
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
08435566643781IPDSCFLIPD/AB-SR-00/FS2026-03-30
08435566643798IPDSCFLIPD/AB-SR-10/FS2026-03-30
08435566643804IPDSCFLIPD/AB-SR-20/FS2026-03-30
08435566643811IPDSCFLIPD/AB-SR-21/FS2026-03-30
08435566643828IPDSCFLIPD/AB-SR-22/FS2026-03-30
08435566643842IPDSCLQIPD/AB-KR-00/FS2026-03-30
08435566643859IPDSCFLIPD/AB-KR-01/FS2026-03-30
08435566643934IPDSCFLIPD/DD-SR-00/FS2026-03-30
08435566643941IPDSCFLIPD/DD-SR-10/FS2026-03-30
08435566643958IPDSCFLIPD/DD-SR-20/FS2026-03-30
08435566643965IPDSCFLIPD/DD-SR-21/FS2026-03-30
08435566643972IPDSCFLIPD/DD-SR-22/FS2026-03-30
08435566643989IPDSCLQIPD/DD-KR-00/FS2026-03-30
08435566643996IPDSCFLIPD/DD-KR-01/FS 2026-03-30
08435566644009IPDSCFLIPD/DD-SN-00/FS2026-03-30
08435566644016IPDSCFLIPD/DD-SN-10/FS2026-03-30
08435566644023IPDSCFLIPD/DD-SN-20/FS2026-03-30
08435566644030IPDSCFLIPD/DD-SN-21/FS2026-03-30
08435566644047IPDSCFLIPD/DD-SN-22/FS2026-03-30
08435566644054IPDSCLQIPD/DD-KN-00/FS2026-03-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810112922530(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922547(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922554(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922561(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922578(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922585(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922592(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922608(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922615(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922622(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922639(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922646(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922653(INOSS System) Abutment ScrewInosys, Inc.NHA2026-08-27
08059224217932OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224217949OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224217956OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224217963OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224217970OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224217987OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224217994OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224218021OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224218045OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224218052OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224218069OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224218076OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224218083OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224218090OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224218106OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224218113OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224218120OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27