FDA.reportPublic FDA data

BIORES Dental Implant System

Primary DI
06932195393602
Brand
BIORES Dental Implant System
Company
Chengdu Besmile Medical Technology Co., Ltd.
Model
BSM-YH-JT4510
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
06932195393602PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06932195393602069321953936026932195393602

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
06942686761223Drill2M34211A2026-08-21
06942686761230Drill3M34291A2026-08-21
06942686761247Drill3M36391A2026-08-21
06942686761254Drill3M34531A2026-08-21
06942686761261Drill3M36531A2026-08-21
06942686761278Drill3M38531A2026-08-21
06942686761285Drill3M34571A2026-08-21
06942686761292Drill3M36571A2026-08-21
06942686761308Drill3M38571A2026-08-21
06942686761315Drill3M34671A2026-08-21
06942686761322Drill3M36671A2026-08-21
06942686761339Drill3M38671A2026-08-21
06942686761346Drill4Z32531A2026-08-21
06942686761353Drill4Z32591A2026-08-21
06942686761360Drill4Z32691A2026-08-21
06942686761377DrillLZ34201A2026-08-21
06942686761384Drill3M36211A2026-08-21
06942686761391Drill4M34311A2026-08-21
06942686761407Drill2M34211A2026-08-21
06942686761414Drill2M36211A2026-08-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842448118561TITAN IMPLANTS INC.TITAN IMPLANT INCNHA2026-09-06
00810125998713ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998720ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998737ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998744ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998751ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998768ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998775ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998782ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998799ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998805ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998812ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998829ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998836ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998843ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998850ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998867ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998874ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998881ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998898ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998904ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998911ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998928ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998935ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998942ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998959EK Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998966EK Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998973EK Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998980EK Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998997EK Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04