FDA.reportPublic FDA data

Odontit

Primary DI
D914IH35100
Brand
Odontit
Company
ODONTIT S.A.
Model
IH-3510
Catalog number
IH-3510
Device description
Internal Hex Rough Surface Acid Eatched w/Mount 3,50 X 10mm
Published
2019-05-28
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
D914IH35100PrimaryHIBCC0

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
+541148250221info@odontit.com

Regulatory Flags#

DUNS number
972044937
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D914SG025L0SCIOGRAFTSG-025-L2024-02-27
D914SG025S0SCIOGRAFTSG-025-S2024-02-27
D914SG050L0SCIOGRAFTSG-050-L2024-02-27
D914SG050S0SCIOGRAFTSG-050-S2024-02-27
D914SG100L0SCIOGRAFTSG-100-L2024-02-27
D914SG100S0SCIOGRAFTSG-100-S2024-02-27
D914SG250L0SCIOGRAFTSG-250-L2024-02-27
D914SG250S0SCIOGRAFTSG-250-S2024-02-27
D914SG500L0SCIOGRAFTSG-500-L2024-02-27
D914SG500S0SCIOGRAFTSG-500-S2024-02-27
D914OSS100005Osseo SealOSS-1000-052023-04-20
D914OSS100010Osseo SealOSS-1000-102023-04-20
D914OSS100040Osseo SealOSS-1000-402023-04-20
D914CEV0205CevOss - CITAGENIXCEV02-052020-02-21
D914CEV0210CevOss - CITAGENIXCEV02-102020-02-21
D914CEV0220CevOss - CITAGENIXCEV02-202020-02-21
D914CEV0250CevOss - CITAGENIXCEV02-502020-02-21
D914CEV0280CevOss - CITAGENIXCEV02-802020-02-21
D914CEV1005CevOss - CITAGENIXCEV10-052020-02-21
D914CEV1010CevOss - CITAGENIXCEV10-102020-02-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840481135989LOCATORZest Anchors, LLCDZE2026-05-22
00840481135996LOCATORZest Anchors, LLCDZE2026-05-22
00840481136009LOCATORZest Anchors, LLCDZE2026-05-22
08806395269907ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269914ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269921ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269938ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269945ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269952ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269969ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269976ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269983ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269990ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395270002ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395270019ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395270026ABBA-ST Strong Co., Ltd.DZE2026-05-22
088000968507858plant Implant System8dent Inc.DZE2026-03-24
088000968507928plant Implant System8dent Inc.DZE2026-03-24
088000968507788plant Implant System8dent Inc.DZE2026-03-23
08800362100002DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100019DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100026DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100033DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100040DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100057DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100064DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100071DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100088DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100095DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100101DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20