FDA.report

Osstem Implant System

Primary DI
08800209300657
Brand
Osstem Implant System
Company
Osstem Implant Co., Ltd.
Model
ASS2R4507S28
Published
2023-10-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
DZEIMPLANT, ENDOSSEOUS, ROOT-FORM

Product Code Classifications

CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Premarket Submissions

SubmissionSupplement
K222778000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K222778000Osstem Implant SystemOsstem Implant Co., Ltd.2023-09-23DZE

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800209300657PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800209300657088002093006578800209300657

GMDN Terms

TermDefinition
Screw endosteal dental implant, two-pieceA sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted 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 is a two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(821)012-3412chicson@osstem.com

Regulatory Flags

DUNS number
689051793
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
08800000987293Bone Screw, Bone TackBSCH14042026-03-09
08800000987309Bone Screw, Bone TackBSCH14062026-03-09
08800000987316Bone Screw, Bone TackBSCH14082026-03-09
08800000987323Bone Screw, Bone TackBSCH20082026-03-09
08800000987330Bone Screw, Bone TackBSCH20102026-03-09
08800000987347Bone Screw, Bone TackBSCH20122026-03-09
08800000987354Bone Screw, Bone TackBSCH20142026-03-09
08800000987361Bone Screw, Bone TackBSCH20162026-03-09
08800040644095Bone ScrewBSCH12032026-03-09
08800040644118Bone ScrewBSCH12042026-03-09
08800040644132Bone ScrewBSCH12052026-03-09
08800040654599Bone Screw, Bone TackOBT32026-03-09
08800040655848OssBuilder SystemSBS2008I2026-03-09
08800040655862OssBuilder SystemSBS2010I2026-03-09
08800040655886OssBuilder SystemSBS2011I2026-03-09
08800040655909OssBuilder SystemSBS2013I2026-03-09
08809892366858SS Abutment SystemSSCAP4814CTH2026-03-09
08809892366896SS Abutment SystemSSCAP4824CTH2026-03-09
08809892366957SS Abutment SystemSSCAP4826ENTH2026-03-09
08809892366964SS Abutment SystemSSCAP4826ETH2026-03-09

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08806395270019ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395270026ABBA-ST Strong Co., Ltd.DZE2026-05-22
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088000968507788plant Implant System8dent Inc.DZE2026-03-23
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