FDA.reportPublic FDA data

Immediate Placement Device

Primary DI
08809823979157
Brand
Immediate Placement Device
Company
EBI Inc.
Model
IPIP
Published
2026-02-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
08809823979157PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809823979157088098239791578809823979157

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant systemA collection of devices designed for the surgical placement of a dental implant into alveolar and/ or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
689515003
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809468050631Precision II ImplantIRAS41102025-10-02
08809468050648Precision II ImplantIRAS41122025-10-02
08809468050877Precision II ImplantIRSS33082025-10-02
08809468051355Precision II ImplantIWSS48082025-10-02
08809475971714Healing AbutmentSHAW7022025-10-02
08809823986223Abutment RemoverABR2025-10-02
08809823990749Double Hex Driver-T/WDBHDTS2025-10-02
08809476186407BLT OS Analog OBLHLAR2024-12-12
08809486111062BLT OS Abutment Screw ONOASR2024-12-12
08809890906483BLT OS Impression CopingONOICTR2024-12-12
08809475970410CCM UCLA Abutment (for Precision) [OCT]EICUC2016-03-29
08809475970427CCM UCLA Abutment (for Precision) [Non-Octa]EICUB2016-03-29
08809475970434CCM UCLA Abutment (for BESTic) [OCT]EBCUC2016-03-09
08809475970441CCM UCLA Abutment (for BESTic) [Non-Octa]EBCUB2016-03-09
08809475970670Precision Gold UCLA AbutmentEIGUC2016-03-02
08809475971684BESTic Healing Abutment SHAR5022017-11-22
08809475971790BESTic Healing Abutment BHAR4242016-03-02
08809475971806BESTic Healing Abutment BHAR4322016-03-02
08809475971868BESTic Healing Abutment BHAR5222016-03-02
08809475971875BESTic Healing Abutment BHAR5232016-03-02

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