FDA.reportPublic FDA data

American Dental Implant

Primary DI
D896GT6016HA0
Brand
American Dental Implant
Company
AMERICAN DENTAL IMPLANT CORPORATION
Model
GT6016HA
Catalog number
GT6016HA
Device description
6.0mm x 16mm XL Diameter Greater Tapered Internal Hex Dental Implant HA Surface
Published
2018-07-31
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K042462000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042462000AMERICAN DENTAL IMPLANTAmerican Dental Implant Corporation2004-09-21DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D896GT6016HA0PrimaryHIBCC0

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
800-511-0661info@americandentalimplant.com

Regulatory Flags#

DUNS number
835556429
Device count
1
Combination product
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D8963250115SD0American Dental Implant3250115SD3250115SD2024-04-10
D896325010SD0American Dental Implant325010SD325010SD2024-04-10
D896325013SD0American Dental Implant325013SD325013SD2024-04-10
D896325015SD0American Dental Implant325015SD325015SD2024-04-10
D8964DTW200American Dental Implant4DTW204DTW202018-07-31
D8964DTW300American Dental Implant4DTW304DTW302018-07-31
D8963ASAB0American Dental Implant3AS-AB3AS-AB2019-02-18
D8963ASB0American Dental Implant3AS-B3AS-B2019-02-18
D8963AS0American Dental Implant3AS3AS2018-07-31
D896AS0American Dental ImplantASAS2018-07-31
D896ASA0American Dental ImplantAS-AAS-A2018-07-31
D896ASAG0American Dental ImplantAS-AGAS-AG2018-07-31
D896ASAP0American Dental ImplantAS-APAS-AP2018-07-31
D896ASG0American Dental ImplantAS-GAS-G2018-07-31
D896ASP0American Dental ImplantAS-PAS-P2018-07-31
D896ASY0American Dental ImplantAS-YAS-Y2018-07-31
D896ADTD200American Dental Implant ADTD20ADTD202018-07-31
D896ADTD20S0American Dental Implant ADTD20SADTD20S2018-07-31
D896ADTD230American Dental Implant ADTD23ADTD232018-07-31
D896ADTD23S0American Dental Implant ADTD23SADTD23S2018-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08806395200535Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200542Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200559Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200566Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200573Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200580Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200597Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200603Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200610Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200627Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200634Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200641Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200658Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200665Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200672Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200689Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200696Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200702Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200719Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200726Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200733Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200740Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200757Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200764Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200771Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200788Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200795Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200801Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200818Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200825Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28