FDA.reportPublic FDA data

OneJet SG

Primary DI
08809917147448
Brand
OneJet SG
Company
Osstem Implant Co.,Ltd.
Model
OJSG
Published
2024-06-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
08809917147448PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809917147448088099171474488809917147448

GMDN Terms#

Term, Definition table
TermDefinition
Dental guided surgery reference plateA non-sterile device in the form of a plate designed for the fabrication of custom-made scan and surgical dental implant templates used by a dentist during the first stage of a guided dental implantation procedure (i.e., drilling holes in the jawbone for implant placement/fixation). It is a plastic plate of a predefined shape and hole configuration for placement of dental guided surgery reference pins to form a link between a chairside cone beam computerized tomography (CBCT) scan and a coordinate system for dental laboratory fabrication of the scan template (used to scan the patient) and then the surgical dental implant template. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
963215286
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800000995809N1N12026-08-27
08800040673866HySil Impression Materials (Heavy, Mono, and Bite)ESS380H2020-11-17
08800040673873HySil Impression Materials (Heavy, Mono, and Bite)ESS380M2020-11-17
08800040673880HySil Impression MaterialsESS400P2020-11-17
08800040673897HySil Impression Materials (Heavy, Mono, and Bite)ESS50B2020-11-17
08800040673903HySil Impression MaterialsESS50EL2020-11-17
08800040673910HySil Impression MaterialsESS50HB2020-11-17
08800040673927HySil Super Fast Impression MaterialsESS50HF2020-11-17
08800040673934HySil Super Fast Impression MaterialsESS50HFB2020-11-17
08800040673941HySil Super Fast Impression MaterialsESS50HFD2020-11-17
08800040673958HySil Impression MaterialsESS50H2020-11-17
08800040673965HySil Impression MaterialsESS50LB2020-11-17
08800040673972HySil Super Fast Impression MaterialsESS50LF2020-11-17
08800040673989HySil Super Fast Impression MaterialsESS50LFB2020-11-17
08800040673996HySil Super Fast Impression MaterialsESS50LFD2020-11-17
08800040674009HySil Impression MaterialsESS50L2020-11-17
08800040674016HySil Impression MaterialsESS50MB2020-11-17
08800040674023HySil Super Fast Impression MaterialsESS50MF2020-11-17
08800040674030HySil Super Fast Impression MaterialsESS50MFB2020-11-17
08800040674047HySil Super Fast Impression MaterialsESS50MFD2020-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06009544039808N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-09-18
06009544039815N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-09-18
08800313235302ScanTargetDENTIS CO. ,LTDNDP2026-09-18
08800313235319ScanTargetDENTIS CO. ,LTDNDP2026-09-18
08800313235326MU Gingival ScanBodyDENTIS CO. ,LTDNDP2026-09-18
08800313235425ScanTarget Bite CapDENTIS CO. ,LTDNDP2026-09-18
08800313235432ScanTarget Bite CapDENTIS CO. ,LTDNDP2026-09-18
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