FDA.reportPublic FDA data

BIORES Dental Implant System

Primary DI
06932195392339
Brand
BIORES Dental Implant System
Company
Chengdu Besmile Medical Technology Co., Ltd.
Model
BSM-ZTG3710
Device description
Implant
Published
2026-02-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
K252286000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252286000BIORES Dental Implant SystemChengdu Besmile Medical Technology Co., Ltd.2026-02-02DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06932195392339PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06932195392339069321953923396932195392339

GMDN Terms#

Term, Definition table
TermDefinition
Basket endosteal dental implant, one-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 one-piece device composed of an anchorage portion (implant body) in the form of a single, double, and/or triple contiguous cylinder(s) that is implanted into bone, and a retention portion (implant abutment) that protrudes through gingival tissues to support the prosthesis.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
554494754
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06932195393831DrillLZ32201C2026-06-10
06932195393848Drill3M36211C2026-06-10
06932195393855Drill4M34311C2026-06-10
06932195393879Drill2M32211C2026-06-10
06932195393886Drill2M34211C2026-06-10
06932195393909Drill2M38211C2026-06-10
06932195393916Drill2M40211C2026-06-10
06932195393923Drill2M36291C2026-06-10
06932195393930Drill2M40291C2026-06-10
06932195393954Drill3M34351C2026-06-10
06932195393961Drill3M36351C2026-06-10
06932195393985Drill3M38351C2026-06-10
06932195393992Drill3M40351C2026-06-10
06932195394012Drill3M34411C2026-06-10
06932195395002DrillQZ32141C2026-06-10
06932195395019DrillQZ32142C2026-06-10
06932195395026DrillQZ34241C2026-06-10
06932195395033DrillQZ34242C2026-06-10
06932195395040DrillLZ34201C2026-06-10
06932195395057DrillLZ34202C2026-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800070203415ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070203422ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070203439ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070203446ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070230367ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070230374ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070230381ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070230398ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229125ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229132ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229149ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229156ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229163ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229170ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229187ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229194ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229200ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229217ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229224ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229231ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229248ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229255ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229262ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229279ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229286ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229293ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229309ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229316ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229323ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229330ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26