FDA.report

One Stage TL Standard

Primary DI
00810027863201
Brand
One Stage TL Standard
Company
I3 IMPLANT LLC
Model
I3013050
Published
2019-06-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications

CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810027863201PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810027863201008100278632018100278632010810027863201

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

Regulatory Flags

DUNS number
026108395
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
00810027860125One Stage TLI30320102019-06-14
00810027860132One Stage TLI30320202019-06-14
00810027860149One Stage TLI30320302019-06-14
00810027860156One Stage TLI30320502019-06-14
00810027860163One Stage TLI30320702019-06-14
00810027860170One Stage TLI30320902019-06-14
00810027860187One Stage TLI30321002019-06-14
00810027860194One Stage TLI30321102019-06-14
00810027860200One Stage TLI30321202019-06-14
00810027860217One Stage TL ImplantI30321302019-06-14
00810027860224One Stage TL ImplantI30321402019-06-14
00810027860231One Stage TL ImplantI30321502019-06-14
00810027860248One Stage TL ImplantI30321602019-06-14
00810027860255One Stage TL ImplantI30330102019-06-14
00810027860262One Stage TL ImplantI30330202019-06-14
00810027860279One Stage TL ImplantI30330302019-06-14
00810027860286One Stage TL ImplantI30330402019-06-14
00810027860293One Stage TL ImplantI30330502019-06-14
00810027860309One Stage TL ImplantI30330602019-06-14
00810027861245Bone Level ImplantI31310102019-06-14

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08806395270026ABBA-ST Strong Co., Ltd.DZE2026-05-22
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08800362100088DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
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08800362100101DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20