Who is the manufacturer of BoniPlus Dental G-Mesh System?

Montjade Engineering Co., Ltd. filed the 510(k) submission for BoniPlus Dental G-Mesh System (K182759).

What is the FDA product code for BoniPlus Dental G-Mesh System?

JEY. It is classified under 21 CFR 872.4760 as a Class 2 device in the Dental panel.

What is the regulatory pathway for BoniPlus Dental G-Mesh System?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like BoniPlus Dental G-Mesh System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

BoniPlus Dental G-Mesh System

Q: What are the predicate devices for BoniPlus Dental G-Mesh System?

Neo Titanium mesh, CTi-mem (K111761).

K182759 · Montjade Engineering Co., Ltd. · JEY · Jul 29, 2020 · Dental

Device Facts

Record ID	K182759
Device Name	BoniPlus Dental G-Mesh System
Applicant	Montjade Engineering Co., Ltd.
Product Code	JEY · Dental
Decision Date	Jul 29, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.4760
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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.

Device Story

BoniPlus Dental G-Mesh System is a non-absorbable titanium screen system used to stabilize and support bone grafts in dento-alveolar bony defect sites. The system consists of a mesh (pure Titanium, ASTM F-67), mesh screws, screw caps, and tacks (Ti-6Al-4V). The device is used by dental clinicians during surgical procedures to facilitate bone neoformation. The mesh acts as a barrier to contain bone graft material and prevent soft tissue ingrowth. The system is provided sterile and is intended for single-patient use. Clinical benefit is derived from the stabilization of bone graft material, which supports guided bone regeneration in the oral cavity.

Clinical Evidence

No clinical test data was used to support the decision of substantial equivalence. Evidence is based on bench testing only, including sterilization verification (gamma), shelf-life testing (tensile, dye penetration, burst, creep), biocompatibility (cytotoxicity, sensitization, reactivity, pyrogenicity), and mechanical performance (three-point bending, axial pullout, torque testing).

Technological Characteristics

Materials: Pure Titanium (ASTM F-67) for mesh; Ti-6Al-4V for screws, caps, and tacks. Dimensions: Mesh thickness 0.1-0.3 mm; various lengths/widths. Energy source: None (mechanical). Connectivity: None. Sterilization: Gamma radiation. Form factor: Mesh screen with fixation accessories.

Indications for Use

Indicated for stabilization and support of bone grafts in dento-alveolar bony defect sites in patients requiring guided bone/tissue regeneration.

Regulatory Classification

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.

Predicate Devices

Neo Titanium mesh, CTi-mem (K111761)

Reference Devices

SMARTbuilder System (K120951)
MC BIO “SuperTack” tack 3mm, 4mm and 5mm (K151540)
GBR System (K170697)

Related Devices

K143730 — GBR System · Jeil Medical Corporation · Jun 10, 2015
K202918 — OsteoSync Ti Dental Mesh · Sites Medical, LLC · Jul 14, 2021
K172354 — OssBuilder System · Osstem Implant Co., Ltd. · Mar 26, 2018
K222367 — SAVE GBR · Dentis Co., Ltd. · Mar 23, 2023
K011698 — STRAUMANN GBR SYSTEM · Institut Straumann AG · Aug 23, 2001

Submission Summary (Full Text)

{0}------------------------------------------------ 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | |-------------------------------------------------------------------------------------------------------------| | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ### 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 PRAStaff@fda.hhs.gov "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." {3}------------------------------------------------ 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, Taichung City 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: {4}------------------------------------------------ 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, 4mm and 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. {5}------------------------------------------------ ## 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 mm L1: 9.0, 25, 40, 50, 60 mm L2: 9.5, 17, 20, 30, 50, 60 mm | | Mesh Screw | Ti-6Al-4V | 2 | OD: 1.6 mm Hex: 2.5 mm L: 8, 12 mm | | Screw Cap | | 1 | Hex: 1.27 mm Height: 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 - {6}------------------------------------------------ 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. {7}------------------------------------------------ | Item | Subject device | Predicate device | Reference device I | Reference device II | Reference device III | Substantial equivalence determination | |--------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name | "BoniPlus" Dental G-Mesh System | Neo Titanium mesh, CTi-mem | SMARTbuilder System | MC BIO “SuperTack” tack 3mm, 4mm and 5mm | GBR System | | | 510(k) No. | (to be assigned) | K111761 | K120951 | K151540 | K170697 | | | Intended Use | "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. | For Stabilization and support bone grafts in dento-alveolar bony defect sites. | The SMARTbuilder is a metal device intended for use with a dental implant to stabilize and support of bone graft in dento-alveolar bony defect sites. | The MC Bio Supertack tacks are used for the stabilization of absorbable and non-absorbable membranes during the bone tissue regeneration and bone repair in the maxillofacial or mandibular area. The MC Bio Supertack system is designed to stabilize barrier membranes onto cortical plate bone, this may be | The device is intended for use in stabilizing and fixating bone grafts, bone filling material and/or barrier membranes used for guided bone/tissue regeneration in the oral cavity. Single patient use only. | Equivalent All the subject, predicate, and reference devices are to stabilize and support of bone graft in dento-alveolar bony defect sites. The only difference with K170697 does not raise any new issue of substantial equivalence. | {8}------------------------------------------------ | | | | | used in maxillofacial or mandibular bone. General patient health, bone type and quality, and functional loads exerted should be considered and carefully evaluated prior to use. | | | |------------|----------------------------------------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Components | Dental G-Mesh, Mesh Screw & Screw Cap, Tack Set | Mesh (Membrane), Mesh Spacer, Spacer Cap, Mesh Screw, Screw Cap | Membrane, Healing Abutment, Height (Spacer), Cover Cap | Tacks and associated instrumentation | Mesh and Screw | Equivalent All the subject, predicate, and reference devices have mesh and its accessories to use in a system device. This difference does not raise any new issue of substantial equivalence. | {9}------------------------------------------------ | Item | Subject device | Reference device I | Substantial equivalence determination | |--------------------|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | - G-Mesh | - K120951 | | | Design | Image: G-Mesh design | Image: K120951 design BD BL BW | Equivalent The 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 | TiGr2 from pure grade 2 Titanium (ASTM F-67) | TiGr2 from pure Titanium grade 2 (ASTM F-67) | Same | | Dimensions (mm) | Thickness (Tk): 0.1 L1: 9.0 L2: 9.5 | Thickness (Tk): 0.1 BW (Buccal width): 8.0, 10.0 BD (Buccal Distance): 5.5 BL (Buccal Length): 7, 9 | Equivalent The 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 | Equivalent The intended use of subject and reference devices is the same. This difference does not raise any new issue of substantial equivalence. | {10}------------------------------------------------ | Item | Subject device - G-Mesh | Predicate device - K111761 | Substantial equivalence determination | |--------------------|----------------------------------------------------|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Design | Image: G-Mesh Design | Image: K111761 Design | Equivalent The intended use of subject and predicate devices is the same. This difference does not raise any new issue of substantial equivalence. | | Material | TiGr2 from pure grade 2 Titanium (ASTM F-67) | TiGr2 from pure Titanium grade 2 (ASTM F-67) | Same | | Dimensions (mm) | Thickness (Tk): 0.1, 0.3 | Thickness (Tk): 0.07 | Equivalent The intended use of subject and predicate 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. | | | 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 | Equivalent The intended use of subject and predicate devices is the same. This difference does not raise any new issue of substantial equivalence. | {11}------------------------------------------------ | 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 | Equivalent The 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: 1.6 Hex: 2.5 L: 8.0, 12.0 | Diameter: 0.85, 1.4, 1.6, 2.0 Length: 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0 | L: 7, 10, 13, 15 Hex: 4 Height: 3 | Equivalent The 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 | | Equivalent The intended use of subject and predicate devices is the same. This difference does not raise any new issue of substantial equivalence. | {12}------------------------------------------------ | Item | Subject device - Tack | Reference device II - K151540 | Substantial equivalence determination | |----------------|--------------------------|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------| | Design | Image: Tack | Image: Tack | Equivalent The intended use of subject and reference devices is the same. This difference does not raise any new issue of substantial equivalence. | | Material | Ti-6Al-4V | Ti-6Al-4V | Same | | Height (mm) | 2.5 | 3, 4, 5 | Equivalent The intended use of subject and reference devices is the same. This difference does not raise any new issue of substantial equivalence. | | Sterilization | Sterile | Provided non-sterile End user sterilized | Equivalent The subject device passed sterilization validation. This difference does not raise any new issue of substantial equivalence. | | Shelf life | 3 years | - | Equivalent The subject device passed shelf-life validation. This difference does not raise any new issue of substantial equivalence. | {13}------------------------------------------------ ### 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.