FDA.reportPublic FDA data

LOTA HA Dental Implant System

Primary DI
08800075736697
Brand
LOTA HA Dental Implant System
Company
KJMEDITECH.CO.,LTD
Model
LOTA204008H
Device description
LOTA HA Dental Implant System -Fixture
Published
2023-06-19
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

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
K202046000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202046000LOTA SLA Dental Implant System and LOTA HA Dental Implant SystemKj Meditech Co., Ltd.2022-03-01DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800075736697PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800075736697088000757366978800075736697

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

Regulatory Flags#

DUNS number
688476027
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809488210060ANCHOR PLUS/NEO ANCHOR PLUSMS-14062019-08-26
08809488210077ANCHOR PLUS/NEO ANCHOR PLUSMS-14072019-08-26
08809488210084ANCHOR PLUS/NEO ANCHOR PLUSMS-14082019-08-26
08809488210091ANCHOR PLUS/NEO ANCHOR PLUSMS-14102019-08-26
08809488210107ANCHOR PLUS/NEO ANCHOR PLUSMS-14122019-08-26
08809488210114ANCHOR PLUS/NEO ANCHOR PLUSMS-16062019-08-26
08809488210121ANCHOR PLUS/NEO ANCHOR PLUSMS-16072019-08-26
08809488210138ANCHOR PLUS/NEO ANCHOR PLUSMS-16082019-08-26
08809488210145ANCHOR PLUS/NEO ANCHOR PLUSMS-16102019-08-26
08809488210152ANCHOR PLUS/NEO ANCHOR PLUSMS-16122019-08-26
08809488210169ANCHOR PLUS/NEO ANCHOR PLUSMSS-14062019-08-26
08809488210176ANCHOR PLUS/NEO ANCHOR PLUSMSS-14072019-08-26
08809488210183ANCHOR PLUS/NEO ANCHOR PLUSMSS-14082019-08-26
08809488210190ANCHOR PLUS/NEO ANCHOR PLUSMSS-14102019-08-26
08809488210206ANCHOR PLUS/NEO ANCHOR PLUSMSS-14122019-08-26
08809488210213ANCHOR PLUS/NEO ANCHOR PLUSMSS-16062019-08-26
08809488210220ANCHOR PLUS/NEO ANCHOR PLUSMSS-16072019-08-26
08809488210237ANCHOR PLUS/NEO ANCHOR PLUSMSS-16082019-08-26
08809488210244ANCHOR PLUS/NEO ANCHOR PLUSMSS-16102019-08-26
08809488210251ANCHOR PLUS/NEO ANCHOR PLUSMSS-16122019-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08800070203330ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203347ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203354ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203361ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203378ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203385ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203392ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203408ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800075200051I DoOneday Biotech Co.,Ltd.DZE2026-06-04
08800075200068I DoOneday Biotech Co.,Ltd.DZE2026-06-04
08800075200075I DoOneday Biotech Co.,Ltd.DZE2026-06-04
08800075200082I DoOneday Biotech Co.,Ltd.DZE2026-06-04
08800075200099I DoOneday Biotech Co.,Ltd.DZE2026-06-04
08800075200105I DoOneday Biotech Co.,Ltd.DZE2026-06-04
08800075200112I DoOneday Biotech Co.,Ltd.DZE2026-06-04
08800075200129I DoOneday Biotech Co.,Ltd.DZE2026-06-04
08800075200136I DoOneday Biotech Co.,Ltd.DZE2026-06-04