FDA.reportPublic FDA data

OneJet SG

Primary DI
08809917147431
Brand
OneJet SG
Company
Osstem Implant Co.,Ltd.
Model
OJSG-500
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
08809917147431PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809917147431088099171474318809917147431

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
08800000996264OSSTEM IMPLANT CO., LTD. CHAIR BUSINESSK52025-09-04
08800000995977OSSTEM IMPLANT CO., LTD. CHAIR BUSINESSK52025-04-24
08800000995984OSSTEM IMPLANT CO., LTD. CHAIR BUSINESSK52025-04-24
08800000996042T2 PlusT2-CS-P2025-04-28
08800000996059T2 PlusT2-C-P2025-04-28
08800209338841Estar-ZEZEHTA2012M2024-12-03
08800209338865Estar-ZEZEHTA2014M2024-12-03
08800209338889Estar-ZEZEHTA2016M2024-12-03
08800209338902Estar-ZEZEHTA2018M2024-12-03
08800209338926Estar-ZEZEHTA2020M2024-12-03
08800209338940Estar-ZEZEHTA2022M2024-12-03
08800209338964Estar-ZEZEHTA2025M2024-12-03
08800209338988Estar-ZEZEHTA2030M2024-12-03
08800209339008Estar-ZEZEHTA3010M2024-12-03
08800209339022Estar-ZEZEHTA3012M2024-12-03
08800209339046Estar-ZEZEHTA3014M2024-12-03
08800209339060Estar-ZEZEHTA3016M2024-12-03
08800209339084Estar-ZEZEHTA3018M2024-12-03
08800209339107Estar-ZEZEHTA3020M2024-12-03
08800209339121Estar-ZEZEHTA3022M2024-12-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842092187722PreatPreat CorporationNDP2026-06-08
08056591028154JDentalCare Dental InstrumentsJ DENTAL CARE SRLNDP2026-06-08
00840481133756LOCATORZest Anchors, LLCNDP2026-06-05
07630031778086NAInstitut Straumann AGNDP2026-06-03
07630031778093NAInstitut Straumann AGNDP2026-06-03
07630031778109NAInstitut Straumann AGNDP2026-06-03
07630031778116NAInstitut Straumann AGNDP2026-06-03
07630031778123NAInstitut Straumann AGNDP2026-06-03
07630031778130NAInstitut Straumann AGNDP2026-06-03
07630031778147NAInstitut Straumann AGNDP2026-06-03
07630031778154NAInstitut Straumann AGNDP2026-06-03
07630031778161NAInstitut Straumann AGNDP2026-06-03
07630031778192NAInstitut Straumann AGNDP2026-06-03
07630031778208NAInstitut Straumann AGNDP2026-06-03
07630031778215NAInstitut Straumann AGNDP2026-06-03
07630031778222NAInstitut Straumann AGNDP2026-06-03
07630031778239NAInstitut Straumann AGNDP2026-06-03
07630031778260NAInstitut Straumann AGNDP2026-06-03
07630031778277NAInstitut Straumann AGNDP2026-06-03
07630031778284NAInstitut Straumann AGNDP2026-06-03
07630031778291NAInstitut Straumann AGNDP2026-06-03
07630031778307NAInstitut Straumann AGNDP2026-06-03
07630031778338NAInstitut Straumann AGNDP2026-06-03
07630031778345NAInstitut Straumann AGNDP2026-06-03
07630031778352NAInstitut Straumann AGNDP2026-06-03
07630031778369NAInstitut Straumann AGNDP2026-06-03
07630031778376NAInstitut Straumann AGNDP2026-06-03
07630031778406NAInstitut Straumann AGNDP2026-06-03
07630031778413NAInstitut Straumann AGNDP2026-06-03
07630031778420NAInstitut Straumann AGNDP2026-06-03