BIORES Dental Implant System

K252286 · Chengdu Besmile Medical Technology Co., Ltd. · DZE · Feb 2, 2026 · Dental

Device Facts

• Record ID: K252286
• Device Name: BIORES Dental Implant System
• Applicant: Chengdu Besmile Medical Technology Co., Ltd.
• Product Code: DZE · Dental
• Decision Date: Feb 2, 2026
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

BIORES Dental Implant System is an endosseous dental implant that is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple-units prosthetic appliance attachment to restore a patient’s chewing function. Implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading when good primary stability has been achieved and with appropriate occlusal loading. Implants with a diameter of 3.7 mm are only suitable for anterior tooth restoration.

Device Story

The BIORES Dental Implant System consists of endosseous dental implants, abutments, and accessories used to restore chewing function in edentulous or partially edentulous patients. The implant is surgically placed into the jawbone by a dental professional. The system provides a root-form foundation for attaching prosthetic appliances (crowns, bridges, overdentures). The implant features a tapered design with internal hex connections and is available in various diameters and lengths. Abutments are screw-retained to the implant body. The device is used in a clinical setting by dentists or oral surgeons. The healthcare provider selects the appropriate implant size and surgical approach (one-stage or two-stage) based on patient anatomy and bone quality. The device benefits patients by providing a stable, functional, and aesthetic replacement for missing teeth.

Clinical Evidence

Bench testing only. Evidence includes biocompatibility (ISO 10993-1, -5), sterilization validation (ISO 11137-1/2, ANSI/AAMI ST79), shelf-life testing (real-time aging), bacterial endotoxin testing (USP <85>), fatigue testing (ISO 14801), surface cleanliness analysis (SEM/EDS), and non-clinical MRI safety assessment based on scientific rationale and literature.

Technological Characteristics

Implant: Titanium Grade 4 (ASTM F67), SLA surface, gamma sterilized. Abutments/Accessories: Ti-6Al-4V ELI (ASTM F136). Design: Tapered internal hex. Dimensions: Diameters 3.7-6.0mm, lengths 8.4-14.4mm. Connectivity: Mechanical screw-retained. Sterilization: Gamma irradiation (implants/some abutments) or steam sterilization (bonding abutments).

Indications for Use

Indicated for surgical placement in upper and lower jaw arches in patients requiring single or multiple-unit prosthetic restoration to restore chewing function. Suitable for conventional two-stage or single-stage surgical processes with immediate loading if primary stability is achieved. 3.7 mm diameter implants are restricted to anterior tooth restoration.

Regulatory Classification

Identification

An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.

Special Controls

*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2) *Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use; (ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads; (iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system; (iv) The device must be demonstrated to be biocompatible; (v) Sterility testing must demonstrate the sterility of the device; (vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment; (vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians; (viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and (ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

Predicate Devices

• Dentis Dental Implant System (K171027)

Reference Devices

• ZENEX Implant System (K211090)
• ST Internal Implant System (K192347)

Submission Summary (Full Text)

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FDA U.S. FOOD &amp; DRUG ADMINISTRATION

February 2, 2026

Chengdu Besmile Medical Technology Co., Ltd.
Moushan Liu
Manager
No.9, Sec.2, Shengwucheng North Rd
Chengdu Tianfu International Bio-Town, Shuangliu District
Chengdu, Sichuan 610200
CHINA

Re: K252286
Trade/Device Name: BIORES Dental Implant System
Regulation Number: 21 CFR 872.3640
Regulation Name: Endosseous Dental Implant
Regulatory Class: Class II
Product Code: DZE, NHA
Dated: July 2, 2025
Received: January 12, 2026

Dear Moushan Liu:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

U.S. Food &amp; Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K252286 - Moushan Liu
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

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K252286 - Moushan Liu
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For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Andrew I. Steen -S

Andrew I. Steen
Assistant Director
DHT1B: Division of Dental and ENT Devices
OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K252286 | |
| Device Name BIORES Dental Implant System | |
| Indications for Use (Describe) BIORES Dental Implant System is an endosseous dental implant that is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple-units prosthetic appliance attachment to restore a patient’s chewing function. Implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading when good primary stability has been achieved and with appropriate occlusal loading. Implants with a diameter of 3.7 mm are only suitable for anterior tooth restoration. | |
| Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail] | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |

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510(k) Summary
K252286

## 1. Submitter

Device Submitter: Chengdu Besmile Medical Technology Co., Ltd.
No.9, Sec.2, Shengwucheng North Rd., Chengdu Tianfu International Bio-Town, Shuangliu District, Chengdu, Sichuan 610200, P.R.China

Contact Person: Moushan Liu (Mr.)
Manager
Phone: [phone]
E-mail: [e-mail]

## 2. Device

Trade Name of Device: BIORES Dental Implant System
Regulation Number: 21 CFR 872.3640
Classification Name: Endosseous dental implant, Endosseous dental implant abutment
Product Code: DZE, NHA
Regulatory Class: Class II
Review Panel: Dental
Date prepared: February 2, 2026

## 3. Predicate Device

### 3.1 Primary predicate device

K171027, Dentis Dental Implant System by Dentis Co., Ltd.

### 3.2 Reference Device

K211090, ZENEX Implant System by Izenimplant Co., Ltd.
K192347, ST Internal Implant System by Megagen Implant Co. Ltd

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## 4. Device Description

BIORES Dental Implant System includes Implant, Abutment and Accessories. Abutment and Accessories are only compatible with our company's Implant to restore patients' chewing function.

Implant is made of Titanium Grade 4 material that complies with ASTM F67 and has a sandblasted and acid-etched surface. The implant is supplied sterile and is gamma sterilized. The sterilization is shelf life for 8 years. Implant is classified into Type I Implant and Type II Implant according to different thread designs. Type I Implant feature conical threaded structures, consisting of a top, neck, and body. The top of the implant is machined (0.4mm length), the neck has trapezoidal micro-threads, and the body has large threads in a reverse sawtooth pattern, with rotational cuts at the large thread locations. Type II Implant have a conical threaded design, consisting of a top, and body. The implant body has large threads, and the large thread area has rotational cuts.

Abutment and Accessories include bonding abutment(straight only), healing abutment, central screw, and cover screw, all made from Ti-6Al-4V ELI titanium alloy material compliant with ASTM F136, without any surface treatment. The bonding abutment is provided non-sterile and must be sterilized by the user using steam sterilization prior to use; the healing abutment, central screw, and cover screw are provided sterile, with a sterilization shelf life of 5 years.

## 5. Indication for use

BIORES Dental Implant System is an endosseous dental implant that is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple-units prosthetic appliance attachment to restore a patient’s chewing function. Implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.

Implants with a diameter of $3.7\mathrm{mm}$ are only suitable for anterior tooth restoration.

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6. Substantial Equivalence Comparison

| Device Characteristic | Subject Device | Primary predicate device | Reference Device | Reference Device | Discussion |
| --- | --- | --- | --- | --- | --- |
| Device name | BIORES Dental Implant System | Dentis Dental Implant System | ZENEX Implant System | ST Internal Implant System | / |
| 510(k) number | K252286 | K171027 | K211090 | K192347 | / |
| Manufacturer | Chengdu Besmile Medical Technology Co., Ltd. | Dentis Co., Ltd. | Izenimplant Co., Ltd. | MegaGen Implant Co., Ltd. | / |
| Product Code | DZE, NHA | DZE, NHA | DZE, NHA | DZE, NHA | Identical |
| Indication for use | BIORES Dental Implant System is an endosseous dental implant that is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple-units prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading when good primary stability has been achieved and with appropriate occlusal loading. | The Dentis Dental Implant System is an endosseous dental implant that is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple-units prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading when good primary | ZENEX Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Wide Fixture System is intended to be used in the | The ST Internal Implant System is intended to be surgically placed in the maxillary or mandibular arches for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function. Smaller implants (less than 6.0 mm) are dedicated for immediate loading when | Similar |

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6.1 Implant

| Device Characteristic | Subject Device | Primary predicate device | Reference Device | Discussion |
| --- | --- | --- | --- | --- |
| Device name | Implant | s-Clean Tapered Fixture | ST Internal Fixture | / |
| 510(k) number | K252286 | K171027 | K192347 | / |
| Material | Titanium Grade 4 (ASTM F67) | CP Titanium Gr.4 (ASTM F67) | CP Ti Grade 4(ASTM F67) | Identical |
| Design | Tapered Internal Hex | Tapered, SAVE, Straight, and SAVE II designs, each Internal Hex connected | Tapered body Internal Hex | Similar Comment 1 |
| Diameter(mm) | Type I: Φ3.7×8.4, 10.4, 12.4, 14.4 Φ4.1×8.4, 10.4, 12.4, 14.4 Φ4.3×8.4, 10.4, 12.4, 14.4 Φ4.8×8.4, 10.4, 12.4, 14.4 Φ5.5×8.4, 10.4, 12.4 | 3.7, 4.1, 4.3, 4.8, 5.5, 6.0mm | 3.7, 4.2, 4.6, 5.1, 6.0, 6.8mm | Similar Comment 12 |
| Length/Retention length(mm) | | 7, 8, 9, 10, 12, 14mm | 7.0, 8.5, 10, 11.5, 13, 15mm | Similar Comment 2 |

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| | Φ6.0×8.4, 10.4, 12.4
Type II:
Φ3.7×8.4, 10.4, 12.4, 14.4
Φ4.1×8.4, 10.4, 12.4, 14.4
Φ4.3×8.4, 10.4, 12.4, 14.4
Φ4.8×8.4, 10.4, 12.4, 14.4
Φ5.5×8.4, 10.4, 12.4
Φ6.0×8.4, 10.4, 12.4 | | | |
| --- | --- | --- | --- | --- |
| Threaded length(mm) | Type I:
Φ3.7×8.0, 10.0, 12.0, 14.0
Φ4.1×8.0, 10.0, 12.0, 14.0
Φ4.3×8.0, 10.0, 12.0, 14.0
Φ4.8×8.0, 10.0, 12.0, 14.0
Φ5.5×8.0, 10.0, 12.0
Φ6.0×8.0, 10.0, 12.0
Type II:
Φ3.7×8.0, 10.0, 12.0, 14.0
Φ4.1×8.0, 10.0, 12.0, 14.0
Φ4.3×8.0, 10.0, 12.0, 14.0
Φ4.8×8.0, 10.0, 12.0, 14.0
Φ5.5×8.0, 10.0, 12.0
Φ6.0×8.0, 10.0, 12.0 | 6.6, 7.6, 8.6, 9.6, 11.6, 13.6mm | 7.0, 8.5, 10, 11.5, 13, 15mm | Similar Comment 3 |
| Thread type | Knife thread | Knife thread | Knife thread | Identical |
| Placement type | Bone level | Bone level | Bone level | Identical |

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| Surface treatment | SLA | RBM | SLA | Different Comment 1 |
| --- | --- | --- | --- | --- |
| Delivery | Sterile | Sterile | Sterile | Identical |
| Sterilization method | Gamma irradiation | Gamma irradiation | Gamma sterilization | Identical |
| Shelf life | 8 years | 8 years | 5 years | Identical |
| Discussion | 1.Similarities The Subject Device and the Primary predicate device K171027 have the same characteristics, including indication for use, material, diameter, thread type, placement type, sterilization method, and shelf life. 2.Differences Similar Comment 1 The Primary predicate device design includes Tapered, SAVE, Straight, and SAVE II, with an internal hex connection type. The Subject Device design is Tapered, with an internal hex connection type, which falls within the design range of the Primary predicate device. Therefore, this difference does not affect substantial equivalence. Similar Comment 12 The diameter of the subject device is identical to that of the primary predicate device. The diameter of the subject device is similar to that of the reference device. The minimum diameter of the Subject Device is 3.7 mm, and the maximum diameter is 6.0 mm. The minimum diameter of the Reference Device is 3.7 mm, and the maximum diameter is 6.8 mm. The diameter of the Reference Device covers the entire range of the Subject Device. | | | |

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Therefore, this difference does not affect substantial equivalence.

Similar Comment 2

The maximum length of the Primary predicate device is 14.0 mm, and the maximum length of the Subject Device is 14.4 mm. To accommodate this difference, Reference Device K1923471 has been added, with a length that covers the entire range of Subject Device dimensions. Therefore, this difference does not affect substantial equivalence.

Similar Comment 3

The threaded length of the Primary predicate device is up to 13.6 mm, while that of the Subject Device is up to 14.0 mm. To accommodate this difference, Reference Devic K192347 has been added, which covers the entire range of dimensions of the Subject Device. Therefore, this difference does not affect substantial equivalence.

Different Comment 1

The surface treatment method for the Primary predicate device is RBM, while that for the Subject Device is SLA. To support this difference, Reference Device K192347 with surface treatment method SLA has been added. Therefore, this difference does not affect substantial equivalence.

## 6.2 Bonding Abutment

| Device Characteristic | Subject Device | Primary predicate device | Discussion |
| --- | --- | --- | --- |
| Device name | Bonding Abutment | s-Clean Sole Abutment | / |

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| 510(k) number | K252286 | K171027 | / |
| --- | --- | --- | --- |
| Material | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI (Grade 5) | Identical |
| Diameter | 4.5, 5.5, 6.5mm | 4.5, 4.8, 5.5, 6.0, 6.5mm | Similar Comment 4 |
| Length | 9.0, 9.5, 10.0, 10.5, 11.0, 11.5, 12.0, 12.5, 13.0, 13.5, 14.0, 15.0mm | 12.5, 13.0, 13.5, 14,15, 16, 17mm | Similar Comment 5 |
| Transmucosal height | 1.0, 1.5, 2.0, 2.5, 3.5, 4.5, 5.5mm | 1.0, 1.5, 2.0, 2.5, 3.5, 4.5, 5.5mm | Identical |
| Post height | 5.5,7.0mm | 5.5, 7.0mm | Identical |
| Retention type to implant body | Screw-retained | Screw-retained | Identical |
| Dental restoration retention type | Bonding | Bonding | Identical |
| Delivery | Non sterile | Non sterile | Identical |
| Sterilization method | Steam sterilization by user | Steam sterilization by user | Identical |
| Discussion | 1.Similarities
The Subject Device and the Primary predicate device K171027 have the same characteristics, including material, transmucosal height, post height, retention type to implant body, dental restoration retention type, delivery, and sterilization method.
2.Differences
Similar Comment 4 | | |

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The diameter of the Primary predicate device includes 4.5, 4.8, 5.5, 6.0, and 6.5mm, while the diameter of the Subject Device is 4.5, 5.5, and 6.5mm, which falls within the size range of the Primary predicate device. Therefore, this difference does not affect substantial equivalence.

Similar Comment 5

The maximum length of the Primary predicate device is 15.0mm, and the maximum length of the Subject Device is 17.0mm, which is within the size range of the Primary predicate device. Therefore, this difference does not affect substantial equivalence.

## 6.3 Healing Abutment

| Device Characteristic | Subject Device | Primary predicate device | Discussion |
| --- | --- | --- | --- |
| Device name | Healing Abutment | s-Clean Healing Abutment | / |
| 510(k) number | K252286 | K171027 | / |
| Material | Ti-6Al-4V ELI (F136) | Pure Titanium (Grade 4) | Different Comment 2 |
| Diameter | 4.5, 5.5, 6.5mm | 4.0, 4.5, 4.8, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5mm | Similar Comment 6 |
| Length | 10.0, 10.5, 11.0, 11.5, 12.5, 13.5, 14.5mm | 9.5, 10.0, 10.5, 11.0, 11.5, 12.0, 12.5, 13.0, 13.5, 14.0mm | Similar Comment 7 |
| Transmucosal height | 1.0, 1.5, 2.0, 2.5, 3.5, 4.5, 5.5mm | 1.0, 1.5, 2.0, 2.5, 3.5, 4.5, 5.5mm | Identical |

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| Delivery | Sterile | Sterile | Identical |
| --- | --- | --- | --- |
| Sterilization method | Gamma irradiation | Gamma Irradiation | Identical |
| Shelf life | 5years | 8 years | Different Comment 3 |
| Discussion | 1.SimilaritiesThe Subject Device and the Primary predicate device K171027 have the same characteristics, including indication for use, delivery and sterilization method.2.DifferencesDifferent Comment 2The material of the Subject Device complies with the ASTM F136 standard and has undergone biological testing in accordance with ISO 10993, with no associated biological risks. Besides, the material is a commonly fabrication materials for abutment with a long history of clinical use. Therefore, this difference does not affect substantial equivalence.Similar Comment 6The diameter of the Primary predicate device is 4.0~7.5mm, while the diameter of the subject device is 4.5, 5.5, or 6.5mm, which falls within the size range of the Primary predicate device. Therefore, this difference does not affect substantial equivalence.Similar Comment 7The length of the Subject Device is 14.5 mm, with a tolerance of ±0.2 mm, which is very close to the length of the Primary predicate device (14.0 mm). The two are essentially equivalent. Therefore, this difference does not affect substantial equivalence. | | |

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6.4 Central screw

| Device Characteristic | Subject Device | Primary predicate device | Discussion |
| --- | --- | --- | --- |
| Device name | Central screw | Abutment screw | / |
| 510(k) number | K252286 | K171027 | / |
| Material | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI (Grade 5) | Identical |
| Diameter | 2.3mm | 2.32mm | Similar Comment 8 |
| Length | 9.8mm | 8.8, 9.2, 9.4, 9.8, 9.95, 10.5 mm | Similar Comment 9 |
| Delivery | Sterile | Non sterile | Different Comment 4 |
| Sterilization method | Gamma irradiation | Steam sterilization by user | Different Comment 5 |
| Discussion | 1.Similarities
The Subject Device and Primary predicate device K171027 have the same characteristics, including indication for use and material.
2.Differences
Similar Comment 8
The diameter of the Subject Device is 2.3 mm, with a tolerance of ±0.2 mm, which differs from the diameter of the Primary | | |

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| | predicate device by 0.02 mm, which is within the diameter range of the Subject Device. Therefore, this difference does not affect substantial equivalence.
Similar Comment 9
The length of the Subject Device is within the dimensions of the Primary predicate device. Therefore, this difference does not affect substantive equivalence.
Different Comment 4/Different Comment 5
The Subject Device is provided sterile after gamma irradiation, and according to ISO 11137-1 and ISO 11137-2, the VDmax25 method confirms that a dose of 25 kGy can achieve the sterility assurance level (10^{-6}). Therefore, this difference does not affect substantial equivalence. |
| --- | --- |

## 6.5 Cover screw

| Device Characteristic | Subject Device | Reference Device | Discussion |
| --- | --- | --- | --- |
| Device name | Cover screw | Cover screw | / |
| 510(k) number | K252286 | K211090 | / |
| Manufacturer | Chengdu Besmile Medical Technology Co., Ltd. | Izenimplant Co., Ltd. | / |
| Material | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI (ASTM F136) | Identical |
| Diameter | 3.5mm | 3.0 ~ 3.9mm | Similar Comment 10 |

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| Length | 7.2mm | 5 ~ 7.3mm | Similar Comment 11 |
| --- | --- | --- | --- |
| Delivery | Sterile | Sterile | Identical |
| Sterilization method | Gamma irradiation | Gamma irradiation | Identical |
| Discussion | 1.Similarities
The Subject Device and the Reference Device K211090 have the same indication for use, material, delivery and sterilization method.
2.Differences
Similar Comment 10/Similar Comment 11
The diameter and length of the Subject Device are both within the dimensions of the Primary predicate device. Therefore, this difference does not affect substantive equivalence. | | |

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# 7. Performance Testing

The following performance data were provided in support of the substantial equivalence determination.

## 7.1 Biocompatibility testing

Conduct biocompatibility evaluation in accordance with ISO 10993-1 Medical devices - Biological evaluation - Part 1: Evaluation and testing in the context of risk management. Cytotoxicity testing was conducted according to ISO 10993 - 5.

## 7.2 Sterilization validation

Irradiation sterilization validation is performed in accordance with ISO 11137-1 and ISO 11137-2 standards, and the VDmax25 method is used to confirm that a dose of 25 kGy achieves the sterility assurance level (10⁻⁶).

Validated according to ANSI/AAMI/ISO 17665-1, 17665-2, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling and ANSI/AAMI ST79:2017 &amp; 2020, validation of steam sterilization showed that it could achieve a sterility assurance level (10⁻⁶).

## 7.3 Shelf life

Through real-time aging, the 8-year shelf life of the Implant and the 5-year shelf life of the Abutment and Accessories meet safety and efficacy requirements.

## 7.4 Pyrogen and Endotoxin Test

Bacterial endotoxin testing (Limulus amebocyte lysate, LAL) was conducted according to ANSI/AAMI ST72 and the endotoxin testing will be conducted on every batch for the subject device with the testing limit of below 20 EU/mL in accordance with the USP 39 &lt;85&gt;.

## 7.5 Fatigue Testing

Fatigue testing was conducted on the worst-case scenario for the declared device in accordance with ISO 14801.

## 7.6 Surface cleanliness analysis

Scanning electron microscopy (SEM) and Energy dispersive X-ray spectroscopy (EDS) confirmed that the Subject Device surface was clean, with no chemical

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residues or particles remaining.

## 7.7 MR Environment Condition

Non-Clinical worst-case MRI review was performed to evaluate the BIORES Dental Implant System devices in the MRI environment using scientific rationale and published literature (e.g., Terry O. Woods, Jana Delfino, &amp; Sunder Rajan. (2019). Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices. Journal of Testing and Evaluation 49.2, 783795), based on the entire system including all variations and material composition. Rationale addressed parameters per the FDA guidance “Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment,” including magnetically induced displacement force and torque.

## 7.8 Non-Clinical Performance Data (Bench)

Performance testing was conducted on the Subject Device according to the technical specification, and the test results meet the standard.

## 8. Conclusion

The subject device and the predicate devices have the similar intended use, have similar technological characteristics, and are made of similar materials.

The documentation submitted in this pre-market notification demonstrates that the Subject Device is substantially equivalent to the Primary predicate device.

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