FDA.report

ZiNova

Primary DI
00860010390030
Brand
ZiNova
Company
Z7, LLC
Model
Z14313
Device description
Zirconia Implant One Piece Ø 4.3 x 13
Published
2025-02-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications

CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Premarket Submissions

SubmissionSupplement
K221488000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K221488000Z7 Zirconia Implant SystemZ7, LLC2023-06-26DZE

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00860010390030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010390030008600103900308600103900300860010390030

GMDN Terms

TermDefinition
Screw endosteal dental implant, one-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 one-piece device composed of an anchorage portion (implant body) in the form of a threaded screw that is implanted into bone, and a retention portion (implant abutment) that protrudes through gingival tissues to support the prosthesis.

Device Sizes

TypeValueUnit
Length13Millimeter
Outer Diameter4.3Millimeter

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius50 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
119454118
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
false
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
00860010390009ZiNovaZ137102025-02-10
00860010390016ZiNovaZ137132025-02-10
00860010390023ZiNovaZ143102025-02-10

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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08800362100200DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100217DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
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08800362100231DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100248DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100255DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100262DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20