FDA.reportPublic FDA data

Yomi One Implant System

Primary DI
05060967630004
Brand
Yomi One Implant System
Company
Neoss AB
Model
24008
Catalog number
24008
Device description
Dental Implant Ø3.5 x 9 mm
Published
2024-02-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060967630004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060967630004050609676300045060967630004

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
PhoneEmail
866 626 3677marketingusa@neoss.com

Regulatory Flags#

DUNS number
509583543
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060440335532Neoss Implant System64080640802023-02-13
05060440335549Neoss Implant System64081640812023-02-13
05060440335556Neoss Implant System64082640822023-02-13
05060440335563Neoss Implant System64083640832023-02-13
05060440334283Neoss Implant System64036640362020-11-27
05060440334290Neoss Implant System64037640372020-11-27
05060967630226Yomi One Implant System54001540012024-02-15
05060967630233Yomi One Implant System54002540022024-02-15
05060967630011Yomi One Implant System24009240092024-02-15
05060967630028Yomi One Implant System24010240102024-02-15
05060967630035Yomi One Implant System24011240112024-02-15
05060967630042Yomi One Implant System24012240122024-02-15
05060967630059Yomi One Implant System24014240142024-02-15
05060967630066Yomi One Implant System24015240152024-02-15
05060967630073Yomi One Implant System24016240162024-02-15
05060967630080Yomi One Implant System24017240172024-02-15
05060967630097Yomi One Implant System24018240182024-02-15
05060967630103Yomi One Implant System24020240202024-02-15
05060967630110Yomi One Implant System24021240212024-02-15
05060967630127Yomi One Implant System24022240222024-02-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630031742124Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742131Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742148Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742155Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742162Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742179Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742186Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742193Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742209Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742216Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742223Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742230Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742247Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742254Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742407Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742414Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742421Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742438Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742445Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742452Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742469Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742476Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742483Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742490Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742506Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742513Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742520Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742537Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742612Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742629Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06