(670 days)
No
The summary describes a physical titanium mesh device used for bone grafting support and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as a "non-absorbable membrane that is made of titanium metal to stabilize and support bone grafts in dento-alveolar bony defect sites," indicating its role in treating medical conditions.
No
The device is a non-absorbable titanium membrane system designed to stabilize and support bone grafts. It is a surgical implant used for bone neoformation, not for diagnosing conditions.
No
The device description explicitly states it is a non-absorbable titanium screen made of pure Titanium, which is a physical hardware component. The performance studies also focus on material properties and physical tests.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the "BoniPlus" Dental G-Mesh System is a non-absorbable membrane used to stabilize and support bone grafts in dento-alveolar bony defect sites. This is a direct therapeutic and structural function within the body.
- Device Description: The description reinforces this by stating it's a "non-absorbable titanium screen" that "helps in bone neoformation." This describes a physical implant used to facilitate a biological process in vivo.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any interaction with bodily specimens for diagnostic purposes.
- Performance Studies: The performance studies listed (sterilization, shelf life, biocompatibility, bench performance) are typical for implantable medical devices, not IVDs.
The "BoniPlus" Dental G-Mesh System is a surgical implant used in dentistry for bone grafting procedures.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
JEY, DZL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dento-alveolar bony defect sites, oral cavity, maxillofacial or mandibular area.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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 , and USP .
- For the pyrogenicity, we conducted endotoxin test (LAL test) to address the presence of bacterial endotoxins. The result of endotoxin level for G-Mesh is
§ 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.
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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, 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 , and USP .
- 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