FDA.reportPublic FDA data

IDI Dental Implant

Primary DI
D747IDI10351051
Brand
IDI Dental Implant
Company
AIDI BIOMEDICAL LLC
Model
IDI-1035-105
Catalog number
IDI-1035-105
Device description
IDI Implant Fixture 3.5mm x 10.5mm(Implant Pack)
Published
2019-07-31
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
K081806000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081806000IDI IMPLANT SYSTEMIdi Biomedical, LLC2008-11-07DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D747IDI10351051PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant systemA collection of devices designed for the surgical placement of a dental implant 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 typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation.

Contacts#

Phone, Email table
PhoneEmail
1-951-678-9626support@aidibiomedical.com

Regulatory Flags#

DUNS number
029453028
Device count
1
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D747IDI22470881AIDI MultiPlatform Dental Implant IDI-2247-088IDI-2247-0882019-10-31
D747IDI2247088A1AIDI MultiPlatform Dental Implant IDI-2247-088-AIDI-2247-088-A2019-10-31
D747IDI22471051AIDI MultiPlatform Dental Implant IDI-2247-105IDI-2247-1052019-10-31
D747IDI2247105A1AIDI MultiPlatform Dental Implant IDI-2247-105-AIDI-2247-105-A2019-10-31
D747IDI22471351AIDI MultiPlatform Dental Implant IDI-2247-135IDI-2247-1352019-10-31
D747IDI2247135A1AIDI MultiPlatform Dental Implant IDI-2247-135-AIDI-2247-135-A2019-10-31
D747IDI22471601AIDI MultiPlatform Dental Implant IDI-2247-160IDI-2247-1602019-10-31
D747IDI2247160A1AIDI MultiPlatform Dental Implant IDI-2247-160-AIDI-2247-160-A2019-10-31
D747IDI225408801AIDI MultiPlatform Dental Implant IDI-2254-088-0IDI-2254-088-02019-10-31
D747IDI22540881AIDI MultiPlatform Dental Implant IDI-2254-088IDI-2254-0882019-10-31
D747IDI2254088A1AIDI MultiPlatform Dental Implant IDI-2254-088-AIDI-2254-088-A2019-10-31
D747IDI225410501AIDI MultiPlatform Dental Implant IDI-2254-105-0IDI-2254-105-02019-10-31
D747IDI22541051AIDI MultiPlatform Dental Implant IDI-2254-105IDI-2254-1052019-10-31
D747IDI2254105A1AIDI MultiPlatform Dental Implant IDI-2254-105-AIDI-2254-105-A2019-10-31
D747IDI225413501AIDI MultiPlatform Dental Implant IDI-2254-135-0IDI-2254-135-02019-10-31
D747IDI22541351AIDI MultiPlatform Dental Implant IDI-2254-135IDI-2254-1352019-10-31
D747IDI2254135A1AIDI MultiPlatform Dental Implant IDI-2254-135-AIDI-2254-135-A2019-10-31
D747IDI225416001AIDI MultiPlatform Dental Implant IDI-2254-160-0IDI-2254-160-02019-10-31
D747IDI22541601AIDI MultiPlatform Dental Implant IDI-2254-160IDI-2254-1602019-10-31
D747IDI2254160A1AIDI MultiPlatform Dental Implant IDI-2254-160-AIDI-2254-160-A2019-10-31

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