(670 days)
"BoniPlus" Dental G-Mesh System is the non-absorbable membrane that is made of titanium metal to stabilize and support bone grafts in dento-alveolar bony defect sites.
The "BoniPlus" Dental G-Mesh System is a non-absorbable titanium screen made of pure Titanium (ASTM F-67), that helps in bone neoformation. They come in many different lengths, widths and thicknesses.
This document describes the "BoniPlus" Dental G-Mesh System, a non-absorbable titanium membrane designed to stabilize and support bone grafts in dento-alveolar bony defect sites. A 510(k) submission was made to the FDA to demonstrate its substantial equivalence to previously cleared predicate and reference devices.
Acceptance Criteria and Reported Device Performance
The acceptance criteria are established through a series of non-clinical tests, and the device's performance is reported to meet these requirements, thus affirming its substantial equivalence to existing devices. The table below summarizes these criteria and the reported performance.
| Test Category | Acceptance Criteria/Requirement Description of Device Performance |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterilization | Compliance with ISO 11137-1, ISO 11137-2, ISO 11737-1, and ISO 11737-2 for gamma sterilization. | Sterilization verification successfully conducted according to the specified ISO standards for gamma sterilization. |
| Shelf Life | Compliance with ASTM F1980, ASTM F1929, ASTM F88/F88M, ASTM D882, BS EN 868-5, and ASTM F1140/F1140M for tensile, dye penetration, burst, and creep tests. | Shelf life determined to be 3 years based on successful completion of tensile test, dye penetration test, burst test, and creep test conforming to the listed ASTM and BS EN standards. |
| Biocompatibility | Compliance with ISO 10993-1, ANSI/AAMI/ISO 10993-5, ISO 10993-10, ISO 10993-2, ANSI/AAMI/ISO 10993-12, USP <85>, and USP <161> for in vitro cytotoxicity, sensitization, intracutaneous reactivity, and pyrogenicity. Pyrogen limit specification for endotoxin level set at 0.01 EU/device. | Biocompatibility tests (in vitro cytotoxicity, sensitization, intracutaneous reactivity, and pyrogenicity) were performed successfully according to the specified ISO, ANSI/AAMI/ISO, and USP standards. Endotoxin levels reported as: <0.002 EU/device for G-Mesh, <0.007 EU/device for Mesh Screw & Screw Cap, and <0.001 EU/device for Tack. All results meet the pyrogen limit specification of 0.01 EU/device. |
| Bench Performance | Compliance with ASTM F382, ISO 14704, and ASTM F543 for three-point bending, axial pullout strength, and torque tests for insertion and removal. | Bench performance tests, including three-point bending test, axial pullout strength test, and torque test for insertion and removal, were conducted. The device meets the requirements of its pre-defined acceptance criteria based on results conforming to ASTM F382, ISO 14704, and ASTM F543. |
| Material | G-Mesh: TiGr2 from pure grade 2 Titanium (ASTM F-67); Mesh Screw, Screw Cap, Tack: Ti-6Al-4V. Matching or equivalent to predicate devices. | Materials are confirmed to be TiGr2 for G-Mesh and Ti-6Al-4V for Mesh Screw, Screw Cap, and Tack, which is the same as or equivalent to the predicate/reference devices, meeting the material acceptance criteria. |
| Dimensional Similarity | The subject device dimensions (G-Mesh: Thickness: 0.1, 0.3mm; L1: 9.0, 25, 40, 50, 60 mm; L2: 9.5, 17, 20, 30, 50, 60 mm; Mesh Screw/Screw Cap: OD: 1.6mm, Hex: 2.5mm, L: 8, 12mm; Tack: Height: 2.5mm) are compared to predicate and reference devices, demonstrating similar intended use and comparative performance. | The comparative performance test results for dimensions of the subject device (G-Mesh, Mesh Screw & Screw Cap, Tack) are similar to and meet the pre-defined criteria when compared to the predicate and reference devices. Minor dimensional differences did not raise new issues of substantial equivalence for intended use. |
| Design | Design features of the "BoniPlus" Dental G-Mesh System, including the G-Mesh, Mesh Screw & Screw Cap, and Tack, are compared with predicate and reference devices to ensure substantial equivalence in intended use, surgical procedure, treatment effect, and fixation method. | The design of the subject device components (G-Mesh, Mesh Screw & Screw Cap, Tack) is found to be substantially equivalent to the predicate and reference devices. Differences (e.g., three claws on the G-Mesh) were determined not to raise any new issues of substantial equivalence, as they serve the same function of fixing bone graft and preventing gum overgrowth. |
Study Information
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Sample sizes used for the test set and the data provenance: Not explicitly stated in the provided document. The document refers to "a series of safety and performance tests," and for some specific tests (e.g., pyrogenicity LAL test), it provides results per device. However, the exact sample sizes for each test are not detailed, nor is the country of origin of the data mentioned. The studies appear to be non-clinical bench and laboratory tests, not human or animal studies.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for the performance tests is established by recognized international and industry standards (ISO, ASTM, ANSI/AAMI, USP) for medical device evaluation. These are objective engineering and biological assessments, not expert consensus based on interpretation.
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Adjudication method for the test set: Not applicable. The tests performed are objective, quantitative measurements against pre-defined pass/fail criteria from international standards.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical dental mesh system, not an AI-assisted diagnostic or therapeutic tool for which MRMC studies would be relevant.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm. The non-clinical tests assess the physical and biological properties of the device itself.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for the non-clinical tests is based on established international engineering and biological testing standards (e.g., ISO, ASTM, USP) which define acceptable ranges or criteria for material properties, sterilization efficacy, biocompatibility, and mechanical performance.
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The sample size for the training set: Not applicable. This document does not describe an AI/ML device that requires a training set.
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How the ground truth for the training set was established: Not applicable.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
July 29, 2020
MontJade Engineering Co., Ltd. Yu Sheng Lin R&D Engineer No.2-1, Gongyequ 7th Road, Xitun District Taichung City 40755 TAIWAN (R.O.C.)
Re: K182759
Trade/Device Name: "BoniPlus" Dental G-Mesh System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY, DZL Dated: July 27, 2020 Received: July 29, 2020
Dear Yu Sheng Lin:
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 (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 located 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.
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for
Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K182759
Device Name "BoniPlus" Dental G-Mesh System
Indications for Use (Describe)
"BoniPlus" Dental G-Mesh System is the non-absorbable membrane that is made of titanium metal to stabilize and support bone grafts in dento-alveolar bony defect sites.
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) |
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Traditional 510(k) Section 5 - 510(k) Summary
510(k) SUMMARY
| 5.1 | Type of Submission: | Traditional |
|---|---|---|
| 5.2 | Date of Summary: | 07/27/2020 |
| 5.3 | Submitter: | MontJade Engineering Co., Ltd. |
| Address: | No.22, Jingke Central 2nd Rd., Nantun Dist, TaichungCity 408018, Taiwan | |
| Phone: | +886-4-2350-6886 | |
| Fax: | +886-4-2350-8998 | |
| Representative: | Jiunn-Liang Chen, President |
5.4 Identification of the Device:
| Proprietary/Trade name: | "BoniPlus" Dental G-Mesh System |
|---|---|
| Primary Product Code: | JEY |
| Secondary Product Code: | DZL |
| Regulation Number: | 872.4760 |
| Regulation Description: | Bone plate |
| Review Panel: | Dental |
| Device Class: | II |
| Basis for the Submission: | New Device |
5.5 Identification of the Predicate Device:
| Predicate Device Name: | Neo Titanium mesh, CTi-mem |
|---|---|
| Applicant: | Neobiotech Co., Ltd. |
| Classification Product Code: | JEY |
| Regulation number: | 872.4760 |
| Device Class: | II |
| 510(k) Number: | K111761 |
5.6 Identification of the Reference Device I: SMARTbuilder System Predicate Device Name:
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Traditional 510(k) Section 5 - 510(k) Summary
| Applicant: | OSSTEM Implant Co., Ltd. |
|---|---|
| Classification Product Code: | JEY |
| Subsequent Product Code: | NHA |
| Regulation number: | 872.4760 |
| Device Class: | II |
| 510(k) Number: | K120951 |
5.7 Identification of the Reference Device II:
| Predicate Device Name: | MC BIO “SuperTack” tack 3mm, 4mmand 5mm |
|---|---|
| Applicant: | Eli-Ka Technologies |
| Classification Product Code: | DZL |
| Regulation number: | 872.4880 |
| Device Class: | II |
| 510(k) Number: | K151540 |
5.8 Identification of the Reference Device III:
| Predicate Device Name: | GBR System |
|---|---|
| Applicant: | SURGIDENT Co., Ltd. |
| Classification Product Code: | JEY |
| Subsequent Product Code: | DZL |
| Regulation number: | 872.4760 |
| Device Class: | II |
| 510(k) Number: | K170697 |
5.9 Indications for Use of the Device
"BoniPlus" Dental G-Mesh System is the non-absorbable membrane that is made of titanium metal to stabilize and support bone grafts in dento-alveolar bony defect sites.
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5.10 Device Description
The "BoniPlus" Dental G-Mesh System is a non-absorbable titanium screen made of pure Titanium (ASTM F-67), that helps in bone neoformation. They come in many different lengths, widths and thicknesses.
| Name | Material | Model quantity | Dimension |
|---|---|---|---|
| Dental G-Mesh | TiGr2 | 11 | Thickness: 0.1, 0.3 mmL1: 9.0, 25, 40, 50, 60 mmL2: 9.5, 17, 20, 30, 50, 60 mm |
| Mesh Screw | Ti-6Al-4V | 2 | OD: 1.6 mmHex: 2.5 mmL: 8, 12 mm |
| Screw Cap | 1 | Hex: 1.27 mmHeight: 3.0 mm | |
| Tack | Ti-6Al-4V | 1 | Height: 2.5 mm |
The class II components under 21 CFR 872.4760 (JEY product code) are as below:
5.11 Non-clinical Testing
A series of safety and performance tests were conducted on the subject device, "BoniPlus" Dental G-Mesh System.
- . Sterilization verification - gamma, according to ISO 11137-1, ISO 11137-2, ISO 11737-1, and ISO 11737-2.
- . Shelf life - tensile test, dye penetration test, burst test, and creep test, according to ASTM F1980. ASTM F1929. ASTM F88/F88M. ASTM F1980. ASTM D882, BS EN 868-5, and ASTM F1140/F1140M
- . Biocompatibility - in vitro cytotoxicity, sensitization, intracutaneous reactivity, and pyrogenicity, according to ISO 10993-1, ANSI/AAMI/ISO 10993-5, ISO 10993-10, ISO 10993-2, ANSI/AAMI/ISO 10993-12, USP <85>, and USP <161>.
- For the pyrogenicity, we conducted endotoxin test (LAL test) to address -
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the presence of bacterial endotoxins. The result of endotoxin level for G-Mesh is <0.002 EU/device, for Mesh Screw & Screw Cap is <0.007 EU/device, and for Tack is <0.001 EU/device, which all meet the pyrogen limit specification we set of 0.01 EU/device.
- . Bench performance - three-point bending test, axial pullout strength test, and torque test for insertion and removal, according to ASTM F382, ISO 14704, and ASTM F543.
All the test results demonstrate "BoniPlus" Dental G-Mesh System meets the requirements of its pre-defined acceptance criteria and intended use, and is substantially equivalent to the predicate and reference devices.
5.12 Clinical and Usability Testing
No clinical test data was used to support the decision of substantial equivalence.
5.13 Substantial Equivalence Determination
The "BoniPlus" Dental G-Mesh System submitted in this 510(k) file is substantially equivalent in intended use, principle of operation/mechanism of action, safety and performance to the cleared device, Neo Titanium mesh, CTi-mem (K111761), SMARTbuilder System (K120951), MC BIO "SuperTack" tack 3mm, 4mm and 5mm (K151540), and GBR System (K170697). Differences between the devices are cited as below.
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| Item | Subject device | Predicate device | Reference device I | Reference device II | Reference device III | Substantial equivalence determination |
|---|---|---|---|---|---|---|
| Trade Name | "BoniPlus"Dental G-MeshSystem | Neo Titaniummesh, CTi-mem | SMARTbuilderSystem | MC BIO “SuperTack”tack 3mm, 4mm and5mm | GBR System | |
| 510(k) No. | (to be assigned) | K111761 | K120951 | K151540 | K170697 | |
| Intended Use | "BoniPlus"Dental G-MeshSystem is thenon-absorbablemembrane thatis made oftitanium metalto stabilize andsupport bonegrafts indento-alveolarbony defectsites. | For Stabilizationand support bonegrafts indento-alveolarbony defect sites. | The SMARTbuilderis a metal deviceintended for usewith a dentalimplant to stabilizeand support of bonegraft indento-alveolar bonydefect sites. | The MC Bio Supertacktacks are used for thestabilization ofabsorbable andnon-absorbablemembranes during thebone tissue regenerationand bone repair in themaxillofacial ormandibular area.The MC Bio Supertacksystem is designed tostabilize barriermembranes onto corticalplate bone, this may be | The device is intendedfor use in stabilizing andfixating bone grafts,bone filling materialand/or barriermembranes used forguided bone/tissueregeneration in the oralcavity. Single patientuse only. | EquivalentAll the subject, predicate,and reference devices are tostabilize and support ofbone graft in dento-alveolarbony defect sites.The only difference withK170697 does not raise anynew issue of substantialequivalence. |
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| used in maxillofacial ormandibular bone.General patient health,bone type and quality,and functional loadsexerted should beconsidered and carefullyevaluated prior to use. | ||||||
|---|---|---|---|---|---|---|
| Components | Dental G-Mesh,Mesh Screw &Screw Cap, TackSet | Mesh(Membrane),Mesh Spacer,Spacer Cap,Mesh Screw,Screw Cap | Membrane, HealingAbutment, Height(Spacer), Cover Cap | Tacks and associatedinstrumentation | Mesh and Screw | EquivalentAll the subject, predicate,and reference devices havemesh and its accessories touse in a system device.This difference does notraise any new issue ofsubstantial equivalence. |
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| Item | Subject device | Reference device I | Substantial equivalence determination |
|---|---|---|---|
| - G-Mesh | - K120951 | ||
| Design | Image: G-Mesh design | Image: K120951 designBDBLBW | EquivalentThe substantive effect of the three claws on the bottom of subject device and relative position of the reference device is the same. It's used to fix the bone graft and avoid the gums growing too fast. This difference does not raise any new issue of substantial equivalence. |
| Material | TiGr2from pure grade 2 Titanium(ASTM F-67) | TiGr2from pure Titanium grade 2(ASTM F-67) | Same |
| Dimensions(mm) | Thickness (Tk): 0.1L1: 9.0L2: 9.5 | Thickness (Tk): 0.1BW (Buccal width): 8.0, 10.0BD (Buccal Distance): 5.5BL (Buccal Length): 7, 9 | EquivalentThe intended use of subject and reference devices is the same, and the result of comparative performance test of both devices is similar and meets the pre-defined criteria. This difference does not raise any new issue of substantial equivalence. |
| Sterilization | Sterile | Sterile | Same |
| Shelf life | 3 years | 5 years | EquivalentThe intended use of subject and reference devices is the same. This difference does not raise any new issue of substantial equivalence. |
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| Item | Subject device- G-Mesh | Predicate device- K111761 | Substantial equivalence determination |
|---|---|---|---|
| Design | Image: G-Mesh Design | Image: K111761 Design | EquivalentThe intended use of subject and predicate devices is the same.This difference does not raise any new issue of substantialequivalence. |
| Material | TiGr2from pure grade 2 Titanium(ASTM F-67) | TiGr2from pure Titanium grade 2(ASTM F-67) | Same |
| Dimensions(mm) | Thickness (Tk): 0.1, 0.3 | Thickness (Tk): 0.07 | EquivalentThe intended use of subject and predicate devices is the same,and the result of comparative performance test of both devicesis similar and meets the pre-defined criteria. This differencedoes not raise any new issue of substantial equivalence. |
| L1: 25, 40, 50, 60 | L1: 20, 25,35,50 | ||
| L2: 17, 20, 30, 50, 60 | L2: 12, 20, 25, 35 | ||
| Sterilization | Sterile | Sterile | Same |
| Shelf life | 3 years | 5 years | EquivalentThe intended use of subject and predicate devices is the same.This difference does not raise any new issue of substantialequivalence. |
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| Item | Subject device- Mesh Screw & Screw Cap | Reference device III- K170697 | Predicate device- K111761 | Substantial equivalence determination |
|---|---|---|---|---|
| Design | Image: Mesh Screw & Screw Cap | Image: Reference device III | Image: Predicate device | EquivalentThe intended use, surgical procedure, treatment effect, and fixed way of subject and predicate devices are all the same. This difference does not raise any new issue of substantial equivalence. |
| Material | Ti-6Al-4V | Ti-6Al-4V | Same | |
| Dimensions(mm) | OD: 1.6Hex: 2.5L: 8.0, 12.0 | Diameter: 0.85, 1.4,1.6, 2.0Length: 3.0, 3.5, 4.0,5.0, 6.0, 8.0, 10.0,12.0 | L: 7, 10, 13,15Hex: 4Height: 3 | EquivalentThe intended use of subject and predicate devices is the same, and the dimension of subject and reference devices is similar. This difference does not raise any new issue of substantial equivalence. |
| Sterilization | Sterile | Sterile | Same | |
| Shelf life | 3 years | 5 years | EquivalentThe intended use of subject and predicate devices is the same. This difference does not raise any new issue of substantial equivalence. |
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| Item | Subject device- Tack | Reference device II- K151540 | Substantial equivalence determination |
|---|---|---|---|
| Design | Image: Tack | Image: Tack | EquivalentThe intended use of subject and reference devices is thesame. This difference does not raise any new issue ofsubstantial equivalence. |
| Material | Ti-6Al-4V | Ti-6Al-4V | Same |
| Height(mm) | 2.5 | 3, 4, 5 | EquivalentThe intended use of subject and reference devices is thesame. This difference does not raise any new issue ofsubstantial equivalence. |
| Sterilization | Sterile | Provided non-sterileEnd user sterilized | EquivalentThe subject device passed sterilization validation. Thisdifference does not raise any new issue of substantialequivalence. |
| Shelf life | 3 years | - | EquivalentThe subject device passed shelf-life validation.Thisdifference does not raise any new issue of substantialequivalence. |
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5.14 Similarity and Difference
The "BoniPlus" Dental G-Mesh System has been compared with predicate device Neo Titanium mesh, CTi-mem, and reference devices SMARTbuilder System & MC BIO "SuperTack" tack 3mm, 4mm and 5mm & GBR System. The subject device has same intended use, principle of operation/mechanism of action, and similar technological specification as the predicate and reference devices. Although there are some specifications that are different between them, the performance test has been completed to demonstrate that the differences between these parameters would not impact the safety and effectiveness of the subject device. The subject device has also undergone safety and performance tests, and the results complied with the test requests. Therefore, the differences between the subject device and the predicate with reference devices do not raise any problem of substantial equivalence. The subject device is substantially equivalent to the predicate and reference devices in intended use, design and performance claims.
5.15 Conclusion
After analyzing non-clinical laboratory studies and safety testing data, it can be concluded that the "BoniPlus" Dental G-Mesh System is substantially equivalent to the predicate and reference devices.
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.