FDA.reportPublic FDA data

IPD

Primary DI
08435566610790
Brand
IPD
Company
IMPLANT PROTESIS DENTAL 2004 SL
Model
PMR
Catalog number
IPD/EA-MW-03
Device description
Straight Multi-unit Ø 4,5/5,0 H 3.5
Published
2025-01-17
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
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
K242819000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242819000IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.2024-12-19NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08435566610790PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08435566610790084355666107908435566610790

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

Contacts#

Phone, Email table
PhoneEmail
+13057983869burbina@ipd2004.com

Regulatory Flags#

DUNS number
467871518
Device count
1
DM exempt
true
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
00810157314789Implant Cover ScrewParagon Implant Mfg., LLCNHA2026-09-21
00810157314796Implant Cover ScrewParagon Implant Mfg., LLCNHA2026-09-21
00810157314802Extender Cover ScrewParagon Implant Mfg., LLCNHA2026-09-21
00810157314819Extender Cover ScrewParagon Implant Mfg., LLCNHA2026-09-21
00810157314826Extender Cover ScrewParagon Implant Mfg., LLCNHA2026-09-21
00810157314833Extender Cover ScrewParagon Implant Mfg., LLCNHA2026-09-21
00810157314840Ext. Healing AbutmentParagon Implant Mfg., LLCNHA2026-09-21
00810157314857Ext. Healing AbutmentParagon Implant Mfg., LLCNHA2026-09-21
00810157314864Ext. Healing AbutmentParagon Implant Mfg., LLCNHA2026-09-21
00810157314871Ext. Healing AbutmentParagon Implant Mfg., LLCNHA2026-09-21
00810157314888Ext. Cont. Straight AbutmentParagon Implant Mfg., LLCNHA2026-09-21
00810157314895Ext. Cont. Straight AbutmentParagon Implant Mfg., LLCNHA2026-09-21
00810157314901Ext. Ti Temporary AbutmentParagon Implant Mfg., LLCNHA2026-09-21
00810157314918Ext. Ti Temporary AbutmentParagon Implant Mfg., LLCNHA2026-09-21
00810157314925Ext. ASC AbutmentParagon Implant Mfg., LLCNHA2026-09-21
00810157314932Ext. ASC AbutmentParagon Implant Mfg., LLCNHA2026-09-21
00810157314949Ext. MUA ScrewParagon Implant Mfg., LLCNHA2026-09-21
00810157314956Ext. MUA ScrewParagon Implant Mfg., LLCNHA2026-09-21
00810157314963Ext. MUA ScrewParagon Implant Mfg., LLCNHA2026-09-21
00810157314970Ext. MUA ScrewParagon Implant Mfg., LLCNHA2026-09-21
00810157314994Ext. MUA ScrewParagon Implant Mfg., LLCNHA2026-09-21
00810157315007Ext. MUA ScrewParagon Implant Mfg., LLCNHA2026-09-21
00810157315014Ext. MUA ScrewParagon Implant Mfg., LLCNHA2026-09-21
00810157315021Ext. MUA ScrewParagon Implant Mfg., LLCNHA2026-09-21
00810157315038Ext. MUA ScrewParagon Implant Mfg., LLCNHA2026-09-21
00810157315045Ext. MUA ScrewParagon Implant Mfg., LLCNHA2026-09-21
00810157315052Ext. MUA ScrewParagon Implant Mfg., LLCNHA2026-09-21
00810157315069Ext. NizLoc Abutment ScrewParagon Implant Mfg., LLCNHA2026-09-21
00810157315076Ext. NizLoc Abutment ScrewParagon Implant Mfg., LLCNHA2026-09-21
00810157315083Ext. NizLoc Abutment ScrewParagon Implant Mfg., LLCNHA2026-09-21