FDA.reportPublic FDA data

BIORES Dental Implant System

Primary DI
06932195393770
Brand
BIORES Dental Implant System
Company
Chengdu Besmile Medical Technology Co., Ltd.
Model
BSM-YH-JT6525
Device description
Abutment and Accessories, healing abutment
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
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

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
06932195393770PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06932195393770069321953937706932195393770

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, permanent, preformedA prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.

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
06932195394227Scan bodyPJ-BSM-FH2026-05-29
06932195394999Torque WrenchBSM-BS30-80 (Interval 5) A/B2026-05-29
06932195392322BIORES Dental Implant SystemBSM-ZTG37082026-02-28
06932195392339BIORES Dental Implant SystemBSM-ZTG37102026-02-28
06932195392346BIORES Dental Implant SystemBSM-ZTG37122026-02-28
06932195392353BIORES Dental Implant SystemBSM-ZTG37142026-02-28
06932195392360BIORES Dental Implant SystemBSM-ZTG41082026-02-28
06932195392377BIORES Dental Implant SystemBSM-ZTG41102026-02-28
06932195392384BIORES Dental Implant SystemBSM-ZTG41122026-02-28
06932195392391BIORES Dental Implant SystemBSM-ZTG41142026-02-28
06932195392407BIORES Dental Implant SystemBSM-ZTG43082026-02-28
06932195392414BIORES Dental Implant SystemBSM-ZTG43102026-02-28
06932195392421BIORES Dental Implant SystemBSM-ZTG43122026-02-28
06932195392438BIORES Dental Implant SystemBSM-ZTG43142026-02-28
06932195392445BIORES Dental Implant SystemBSM-ZTG48082026-02-28
06932195392452BIORES Dental Implant SystemBSM-ZTG48102026-02-28
06932195392469BIORES Dental Implant SystemBSM-ZTG48122026-02-28
06932195392476BIORES Dental Implant SystemBSM-ZTG48142026-02-28
06932195392483BIORES Dental Implant SystemBSM-ZTG55082026-02-28
06932195392490BIORES Dental Implant SystemBSM-ZTG55102026-02-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842092170199PreatPreat CorporationNHA2026-06-09
00842092174999PreatPreat CorporationNHA2026-06-09
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04260516873079SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873086SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873093SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873109SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
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04260516874465SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874472SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
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04260516874540SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
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