FDA.reportPublic FDA data

IPD

Primary DI
08435566642050
Brand
IPD
Company
IMPLANT PROTESIS DENTAL 2004 SL
Model
PREM
Catalog number
IPD/DE-XR-00
Device description
IPDmilled RT - GH 0.5 / Ti Blank Ø 12 mm
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
08435566642050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08435566642050084355666420508435566642050

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, permanent, preformedA prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.

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
088000968582488plant Implant System8dent Inc.NHA2026-10-28
088000968583238plant Implant System8dent Inc.NHA2026-10-28
088000968583308plant Implant System8dent Inc.NHA2026-10-28
088000968583548plant Implant System8dent Inc.NHA2026-10-28
088000968583618plant Implant System8dent Inc.NHA2026-10-28
088000968583928plant Implant System8dent Inc.NHA2026-10-28
088000968585218plant Implant System8dent Inc.NHA2026-10-28
088000968585388plant Implant System8dent Inc.NHA2026-10-28
088000968585458plant Implant System8dent Inc.NHA2026-10-28
088000968585698plant Implant System8dent Inc.NHA2026-10-28
088000968585768plant Implant System8dent Inc.NHA2026-10-28
088000968585838plant Implant System8dent Inc.NHA2026-10-28
088000968586068plant Implant System8dent Inc.NHA2026-10-28
088000968586138plant Implant System8dent Inc.NHA2026-10-28
088000968586208plant Implant System8dent Inc.NHA2026-10-28
088000968587508plant Implant System8dent Inc.NHA2026-10-28
088000968601668plant Implant System8dent Inc.NHA2026-10-28
088000968604018plant Implant System8dent Inc.NHA2026-10-28
088000968604258plant Implant System8dent Inc.NHA2026-10-28
088000968604328plant Implant System8dent Inc.NHA2026-10-28
088000968604568plant Implant System8dent Inc.NHA2026-10-28
088000968604638plant Implant System8dent Inc.NHA2026-10-28
088000968650488plant Implant System8dent Inc.NHA2026-10-28
088000968650558plant Implant System8dent Inc.NHA2026-10-28
088000968650628plant Implant System8dent Inc.NHA2026-10-28
08809984971922S-PlantIDIS CO.,LTDNHA2026-10-26
088000968514098plant Implant System8dent Inc.NHA2026-10-23
088000968514168plant Implant System8dent Inc.NHA2026-10-23
088000968514238plant Implant System8dent Inc.NHA2026-10-23
088000968515468plant Implant System8dent Inc.NHA2026-10-23