FDA.reportPublic FDA data

IPD

Primary DI
08435566643859
Brand
IPD
Company
IMPLANT PROTESIS DENTAL 2004 SL
Model
SCFL
Catalog number
IPD/AB-KR-01/FS
Device description
Scan Flag iQ Set MUA Ø 4.8
Published
2026-03-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
08435566643859PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08435566643859084355666438598435566643859

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant abutment analog, intraoral-scanning, single-useAn intraoral device intended to be used as a temporary copy of a dental implant abutment for attachment to a final dental implant and/or implant abutment during a scanning procedure to confirm its orientation/position as part of a dental restoration; it may in addition be intended for laboratory scanning. It is typically made of a radiopaque material (e.g., barium sulfate) and may be used in conjunction with an intraoral x-ray sensor. This is a single-use device.

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
Premarket 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
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
08435566644061IPDSCFLIPD/DD-KN-01/FS2026-03-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08059224151496OT EQUATOR-OT BRIDGERHEIN 83 SRLNDP2026-08-27
08059224151502OT EQUATOR-OT BRIDGERHEIN 83 SRLNDP2026-08-27
08059224151588OT EQUATORRHEIN 83 SRLNDP2026-08-27
08059224218205OT EQUATORRHEIN 83 SRLNDP2026-08-27
08059224218335OT EQUATORRHEIN 83 SRLNDP2026-08-27
08059224218700OT EQUATOR-OT BRIDGERHEIN 83 SRLNDP2026-08-27
08059224218717OT EQUATOR-OT BRIDGERHEIN 83 SRLNDP2026-08-27
08800131092064DenQ Sub Multi-unit Pick-up Impression copingDenQ Co.,Ltd.NDP2026-08-25
08800131098264DenQ Sub Multi-unit Lab AnalogDenQ Co.,Ltd.NDP2026-08-25
00840481138041LOCATOR Angled AbutmentZest Anchors, LLCNDP2026-08-21
00840481138058LOCATOR Angled AbutmentZest Anchors, LLCNDP2026-08-21
08800313235449Guide Anchor PinDENTIS CO. ,LTDNDP2026-08-19
08800313235456Guide Bone AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235463Guide Bone AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235470Guide Bone AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235487Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235494Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235500Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235517Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235524Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235531Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235548Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235555Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235562Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
04260516875448SIC invent Dental Implant SystemsSIC invent AGNDP2026-08-18
04260516875455SIC invent Dental Implant SystemsSIC invent AGNDP2026-08-18
04260516875462SIC invent Dental Implant SystemsSIC invent AGNDP2026-08-18
04260516875479SIC invent Dental Implant SystemsSIC invent AGNDP2026-08-18
04260516878197SIC invent Dental Implant SystemsSIC invent AGNDP2026-08-18
07290108810639Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18