FDA.reportPublic FDA data

AIDI MultiPlatform Dental Implant

Primary DI
D747IDI22471601
Brand
AIDI MultiPlatform Dental Implant
Company
AIDI BIOMEDICAL LLC
Model
IDI-2247-160
Catalog number
IDI-2247-160
Device description
AIDI Bioperfect® MultiPlatform ® Implant 4.7mm x 16.0mm, 3.5mm Platform(Implant Pack)
Published
2019-10-31
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
K101755000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101755000AIDI DENTAL IMPLANT SYSTEMAidi Biomedical, LLC2010-11-22DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D747IDI22471601PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method

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
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
D747IDI124708801AIDI MultiMargin Dental Implant IDI-1247-088-0IDI-1247-088-02019-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800070228951ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070228968ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070228975ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070228982ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070228999ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229002ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229019ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229026ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229033ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229040ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229057ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229064ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229071ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229088ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229095ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229101ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229118ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070203156ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203217ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203224ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203231ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203248ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203255ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203262ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203279ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203286ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203293ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203309ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203316ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203323ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04