Guided Bone Regeneration System
Device Facts
| Record ID | K254286 |
|---|---|
| Device Name | Guided Bone Regeneration System |
| Applicant | DentalMaster(Xiamen)Medical Technology Co., Ltd. |
| Product Code | DZL · Dental |
| Decision Date | Aug 24, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.4880 |
| Device Class | Class 2 |
Indications for Use
The Guided Bone Regeneration System is indicated for the fixation and stabilization of bone grafts and bone filling materials in alveolar bone defects during alveolar bone augmentation procedures.
Device Story
Guided Bone Regeneration System consists of titanium alloy bone screws and tenting screws used as intraoral implants. The device is used by dental surgeons to fixate and stabilize bone grafts or filling materials within alveolar bone defects during augmentation procedures. The screws are provided in sterile or non-sterile formats; non-sterile versions require steam sterilization by the clinician before use. The device functions as a mechanical fixation system to maintain graft position during the healing process. The output is the physical stabilization of the graft material, which facilitates bone regeneration. The device is intended for single use only.
Clinical Evidence
No clinical data provided. Substantial equivalence is supported by bench testing, including biocompatibility (ISO 10993 series), sterilization validation (ISO 11137, ISO 17665), packaging validation (ISO 11607, ASTM F1980, ISTA 2A), and mechanical testing (axial pullout, insertion/removal, torsion, and self-tapping) performed in accordance with ASTM F543-23.
Technological Characteristics
Materials: Ti-6Al-4V ELI titanium alloy (ASTM F136). Surface: Anodic oxidation. Dimensions: Bone screws (1.0-1.3mm diameter, 4-14mm length); Tenting screws (1.6mm diameter, 6-14mm length). Sterilization: Gamma irradiation (sterile) or steam sterilization (non-sterile). Mechanical testing: Performed per ASTM F543-23.
Indications for Use
Indicated for fixation and stabilization of bone grafts and bone filling materials in alveolar bone defects during alveolar bone augmentation procedures in patients requiring dental bone grafting.
Regulatory Classification
Identification
An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.
Predicate Devices
- Micro Screw System (K201210)
Reference Devices
- Salvin Tenting Screw System (K161857)
Submission Summary (Full Text)
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August 24, 2026
DentalMaster(Xiamen)Medical Technology Co., Ltd.
Junfeng Li
Registration and Clinical Evaluation Manager
#19-2, Dingshan Middle Rd., Haicang District
Xiamen, Fujian 361027
China
Re: K254286
Trade/Device Name: Guided Bone Regeneration System
Regulation Number: 21 CFR 872.4880
Regulation Name: Intraosseous Fixation Screw Or Wire
Regulatory Class: Class II
Product Code: DZL
Dated: August 6, 2026
Received: August 6, 2026
Dear Junfeng Li:
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.
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"
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K254286 - Junfeng Li
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(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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 Management System Regulation (QMSR) (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.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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K254286 - Junfeng Li
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Sincerely,
*Sherrill Lathrop Blitzer*
for Andrew 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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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)
K254286
Device Name
Guided Bone Regeneration System
Indications for Use (Describe)
The Guided Bone Regeneration System is indicated for the fixation and stabilization of bone grafts and bone filling materials in alveolar bone defects during alveolar bone augmentation procedures.
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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PSC Publishing Services (301) 443-6740 EF
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K254286
510(k) Summary
## 510(k) Summary
| 1. Submitter | |
| --- | --- |
| **Name** | DentalMaster (Xiamen) Medical Technology Co., Ltd. |
| **Address** | No.19-2, Dingshan Middle Road, Haicang District, 361027, Xiamen, Fujian, PEOPLE'S REPUBLIC OF CHINA. |
| **Phone** | +86 592 6587078 |
| **Contact person** | Junfeng Li |
| **Date prepared** | August 24, 2026 |
| 2. Proposed Device | |
| **Trade/proprietary name** | Guided Bone Regeneration System |
| **Regulation Description** | Intraosseous fixation screw or wire |
| **Regulation number** | 21 CFR 872.4880 |
| **Product code** | DZL |
| **Regulatory class** | II |
| **Classification panel** | Dental |
| 3. Predicate Device | |
| **Legally marketed device(s) to which equivalence is claimed** | **Predicate device:** K201210 Micro Screw System **Reference device:** K161857 Salvin Tenting Screw System |
| **Reason for 510(k) submission** | New device |
### 4. Device Description
Guided Bone Regeneration System consists of Bone Screws and Tenting Screws. The system is an intraoral implant. The implants are provided as sterile and non-sterile. The non-sterile devices must be sterilized before use. The implants are intended for single use only.
Guided Bone Regeneration System is made of titanium alloy which meets ASTM F136.
Diameters of Bone Screws are 1.0mm and 1.3mm, and the lengths are within 4-14mm. Diameter of Tenting Screws is 1.6 mm and the lengths are within 6-14mm. Surface of subject devices are treated with anodic oxidation.
### 5. Indication for Use
The Guided Bone Regeneration System is indicated for the fixation and stabilization of bone grafts and bone filling materials in alveolar bone defects during alveolar bone augmentation p
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K254286
510(k) Summary
procedures.
## 6. Comparison of Technological Characteristics with the Predicate Device
The rationale for substantial equivalence is based on consideration of the following characteristics:
**Regulatory Classification**: Identical to the predicate devices
**Indications for Use**: Substantially equivalent (SE) to the predicate devices. The indications of the subject devices are within the indications of the predicate device.
**Materials**: Substantially equivalent (SE) to the predicate devices
**Design Features**: The dimensions of the subject devices are similar to the dimensions of the predicate devices. Differences in design features have been evaluated via performance testing.
| Item | Proposed Device | Predicate Device | Reference Device |
| --- | --- | --- | --- |
| Product Name | Guided Bone Regeneration System | Micro Screw System | Tenting Screw |
| 510(k) No. | K254286 | K201210 | K161857 |
| Regulation No. | 872.4880 | 872.4880 | 872.4880 |
| Classification | II | II | II |
| Product Code | DZL | DZL | DZL |
| Provided Sterile or Non-sterile | Non-sterile and sterile | Non-sterile | Non-sterile |
| Indications for use | The Guided Bone Regeneration System is indicated for the fixation and stabilization of bone grafts and bone filling materials in alveolar bone defects during alveolar bone augmentation procedures. | The Micro Screw System, Micro Screw System Basic are developed and manufactured to be used as non-active bone surgery implants for the treatment of bone fractures, especially for the fixation of transplanted bone blocks during the augmentation process in the oral cavity and maxillomandibular surgical field. Note: Micro Screws are not intended to remain in the body permanently. After they have fulfilled their supportive function such as is the case after healing of a transplant, or healing of a fracture, for example, they need to be removed completely. | The Salvin Tenting Screw is used to stabilize, fixate, and/or support bone grafts, bone filling materials and / or barrier membranes used for regeneration of bone in the oral cavity. |
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K254286
510(k) Summary
| Sizes | Bone Screws:Diameter (mm): 1.0-1.3Length(mm): 4.0-14.0Tenting screws:Diameter (mm): 1.6Length(mm): 6.0-14.0 | Diameter (mm): 1.0 -1.2Length(mm): 4.0-14.0 | Diameter (mm): 1.5Length(mm): 7.0-9.0 |
| --- | --- | --- | --- |
| Material | Ti-6Al-4V ELI per ASTM F136 | Stainless Steel Per ASTM F138 | Ti-6Al-4V ELI per ASTM F136 |
| Surface treatment | Anodic oxidation. | Metallic- colored surface, no special surface treatment | Metallic- colored surface, no special surface treatment |
| Sterilization methods | Steam and Irradiation sterilization | Steam sterilization | Steam sterilization |
## 7. Non-Clinical Performance Data
### 7.1 Biocompatibility testing
The biocompatibility evaluation for the Guided Bone Regeneration System was conducted on a relevant test article in accordance with the FDA Guidance “Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The standards followed by each biocompatibility test are shown in Table below.
| Test items | Reference Standards |
| --- | --- |
| Test For In Vitro Cytotoxicity | ISO 10993-5:2009 |
| Guinea Pig Maximization Sensitization Test | ISO 10993-10: 2021 |
| Intracutaneous Reactivity Test | ISO10993-23: 2021 |
| Acute Systemic Toxicity Test | ISO 10993-11:2017 |
| Material Mediated Pyrogen Test | ISO 10993-11: 2017 |
| Subchronic Systemic Toxicity | ISO 10993-11:2017 |
| Bacterial Reverse Mutation Test | ISO 10993-3: 2014 |
| In Vitro Mouse Lymphoma Assay | |
| Hemolysis Test-Direct Contact And Extract Methods | ISO 10993-4: 2017 |
| Bone Implantation Test | ISO 10993-6:2016 |
| Subcutaneous Implantation Test | ISO 10993-6:2016 |
### 7.2 Sterilization and Packaging Validation
The Guided Bone Regeneration System is provided as sterile and non-sterile.. The shelf life of the sterile device is 5 years.
Sterile devices are sterilized by gamma irradiation sterilization, which was validated per ISO 11137 and demonstrated a Sterility Assurance Level (SAL) of \(10^{\circ}\) can be ensured. The sterile barrier system is designed to ensure the Sterility Assurance Level and protect the device
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K254286
510(k) Summary
during storage and transportation. Package performance verification was performed per ISO 11607, ASTM F1980, and ISTA 2A.
Non-sterile devices shall be steam sterilized before use. The steam sterilization was validated per ISO 17665.
### 7.3 Mechanical testing
The axial pullout strength, insertion/removal test, torsion test and self-tapping test were performed per ASTM F543-23 Standard Specification and Test Methods for Metallic Medical Bone Screws) for both models of the subject device. The performance of the subject devices was compared to the relevant predicate device and demonstrated substantially equivalent performance.
### 8. Clinical Data
No clinical performance data was provided to demonstrate substantial equivalence.
### 9. Conclusion
Guided Bone Regeneration System is compared to the predicate devices. The information provided within this premarket notification demonstrates that proposed device is determined to be substantially equivalent (SE) to the predicate device.
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