FDA.report

One Stage TL SP

Primary DI
00850008541124
Brand
One Stage TL SP
Company
I3 IMPLANT LLC
Model
i312040
Published
2019-05-27
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
00850008541124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850008541124008500085411248500085411240850008541124

GMDN Terms

TermDefinition
Dental implant analogA device intended to be used as a copy of a dental implant, for a dental laboratory working model, to duplicate the location and restorative platform orientation of the final dental implant; it is not intended for intraoral use. It is a rod-like device made of metal [e.g., titanium (Ti)]. This is a single-use device.

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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