(225 days)
An endosseous dental implant is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple unit prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional 2 stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Patients must be subject for dental treatment with endosseous implants.
The BIOMATE Dental Implant System consists of threaded dental implants in 3.3, 4.1, 4.8, 5.5 mm diameters with 8, 10, 12, 14 mm lengths. The implants are made of commercial pure titanium and coated with the laser-modified Surface. BIOMATE Dental Implant System is comprised of Bone Type Implant, Solid Abutment, Simple Abutment, Angled Abutment, Temporary Abutment, Ball Abutment, Screw, Cover Screw, Healing Abutment. The system is designed for conventional two-stage and single stage procedures for single and multiple unit prosthetics. It is intended to be used to replace missing teeth.
This document is a 510(k) premarket notification for the Biomate Dental Implant System. It primarily demonstrates substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for an AI/ML device. Therefore, much of the requested information regarding AI/ML study design, such as sample sizes for test/training sets, expert qualifications, and adjudication methods, is not applicable or available in this document.
However, I can extract information related to the device's non-clinical performance and acceptance criteria as demonstrated through testing for regulatory approval.
1. A table of acceptance criteria and the reported device performance
The document states that "Design Verification activities were performed on Biomate Dental Implant System and all tests were verified to meet the required acceptance criteria." It then lists the standards followed for various non-clinical tests. While specific numerical acceptance criteria (e.g., minimum tensile strength of X N) and exact reported performance values are not detailed in this summary, the document explicitly states that the device met these criteria as per the standards.
| Test Category | Standard(s) Followed | Acceptance Criteria (Implicitly Met) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | ISO 10993-3, ISO 10993-5, ISO 10993-6, ISO 10993-10, ISO 10993-11, ISO 10933-12 | Biocompatibility requirements as defined by the referenced ISO 10993 series (e.g., non-cytotoxic, non-sensitizing, non-irritant, appropriate systemic toxicity, etc., depending on specific parts). The device must not cause unacceptable biological reactions when in contact with the body. | "Biocompatibility testing... demonstrate that the device is in compliance with the following standards..." (Implies that the device met all established biocompatibility criteria as per the standards). |
| Sterilization | ISO 11137-1, ISO 11137-2, ISO 11737-1, ISO 11737-2 | Sterility assurance level (SAL) requirements (typically 10^-6 for terminally sterilized medical devices), bioburden limits, and other validation criteria as defined by the referenced ISO 11137 and ISO 11737 series. | "sterilization validation and sterility testing - ISO 11137-1, ISO 11137-2, ISO 11737-1, ISO 11737-2... demonstrate that the device is in compliance with the following standards..." (Implies that the device achieved the required SAL and validated its sterilization process). |
| Fatigue Testing | ISO 14801 | Fatigue strength requirements to withstand expected physiological loading cycles over the device's intended lifespan without failure. This includes specific load magnitudes, cycles, and survival rates as defined by the standard for endosseous dental implants. | "fatigue testing -ISO 14801... demonstrate that the device is in compliance with the following standards..." (Implies that the device successfully met the fatigue life and strength criteria as specified by ISO 14801). |
| General Device Design & Function | "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant and Endosseous Dental Implant Abutments" | Requirements for mechanical integrity, compatibility with abutments/prosthetics, dimensional accuracy, material specifications (e.g., ASTM F67 Grade 4 titanium), and overall functional performance as per the guidance document. | "Design Verification activities were performed on Biomate Dental Implant System and all tests were verified to meet the required acceptance criteria." and "There are no significant differences between Biomate Dental Implant System and the predicate devices that would adversely affect the use of the product." (Indicates all design and functional aspects met specified criteria). |
2. Sample sizes used for the test set and the data provenance
The document does not specify exact sample sizes for each non-clinical test (e.g., number of implant samples for fatigue testing). It refers to the standards (e.g., ISO 14801, ISO 10993 series) which would typically dictate appropriate sample sizes for testing to achieve statistical significance or meet regulatory requirements.
The data provenance is for a device manufactured by Biomate Medical Devices Technology Co., Ltd. in Kaohsiung City, Taiwan. The tests are non-clinical bench tests, not clinical studies involving patient data. Therefore, "country of origin of the data" would refer to where the tests were performed (presumably conducted or overseen by Biomate or accredited labs on their behalf), and it is not retrospective or prospective clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable as the document describes non-clinical bench testing for a physical medical device, not an AI/ML algorithm requiring expert ground truth for interpretation of medical images or other data. The "ground truth" for these tests are objective measurements against established engineering and biological standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable as the document describes non-clinical bench testing, which does not involve human adjudication for interpretative tasks. Test results are typically objective measurements against preset pass/fail criteria from the standards.
5. 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
This question is not applicable as no clinical studies are mentioned, and the device is a physical dental implant, not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a physical dental implant, not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests described:
- Biocompatibility: Ground truth is established by the specified biological effects or lack thereof, as defined by the ISO 10993 series, often involving cellular assays, animal studies, or chemical analyses.
- Sterilization: Ground truth is the demonstration of sterility to a defined sterility assurance level (SAL), measured through biological indicator inactivation and physical/chemical validation as per ISO 11137 and ISO 11737.
- Fatigue Testing: Ground truth is based on the material's ability to withstand a specified number of load cycles at a given force without mechanical failure, as defined by ISO 14801.
- General Device Performance: Ground truth is the objective measurement of mechanical properties, dimensional accuracy, and material composition against engineering specifications and the "Class II Special Controls Guidance Document."
8. The sample size for the training set
This question is not applicable as the document is about a physical dental implant and does not involve a training set for an AI/ML algorithm.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as above.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus-like symbol with three human profiles merging into a single form, representing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The seal is simple, using black lines on a white background.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 20, 2015
Biomate Medical Devices Technology Co., Ltd. Mr. Wayne Chen Quality Assurance Engineer 1F. No. 59, Luke 2nd Rd., Luzhu District Kaohsiung City, 820 TAIWAN
Re: K142174
Trade/Device Name: Biomate Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: II Product Code: DZE, NHA Dated: February 7, 2015 Received: February 19, 2015
Dear Mr. Chen:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina
Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number : K142174
Device Name: Biomate Dental Implant System
Indications for Use:
An endosseous dental implant is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple unit prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional 2 stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loadinq. Patients must be subject for dental treatment with endosseous implants.
Prescription Use ____ v________________________________________ (Part 21 CFR 801 Subpart D)
Over-The-Counter Use _
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
{3}------------------------------------------------
510(k) Summary
[As required by 21 CFR 807.92]
1. Date Prepared
March 19, 2015
2. Submitter's Information
| Name of Sponsor: | Biomate Medical Devices Technology |
|---|---|
| Co., Ltd. | |
| Address: | 1F. No.59, Luke 2nd Rd., Luzhu Dist. |
| Kaohsiung City, Taiwan. | |
| Contact Name: | Wayne Chen |
| Telephone No.: | +886-7- 9525999, ext. 881 |
| Fax No.: | +886-7- 6213163 |
| Email Address: | Japostle@biomate-device.com.tw |
3. Trade Name, Common Name, Classification
| Trade Name: | Biomate Dental Implant System |
|---|---|
| Common Name: | Implant, Endosseous, Root-form |
| Classification Name: | Implant, Endosseous, Root-form |
| Classification Panel: | Dental |
| Classification Regulation: | 21 CFR 872.3640 |
| Product Code: | DZE |
| Subsequent Product Code: | NHA |
| Device Class: | II |
4. Identification of Predicate Device(s)
The identified predicates within this submission are as follows:
| 510(k) Number | K070562 (primary predicate) | K073268 |
|---|---|---|
| Applicant | Mega'Gen Co., Ltd | BIOHORIZONS IMPLANTSYSTEMS, INC. |
| Device Name | EZ PLUS IMPLANT SYSTEMS | BIOHORIZONS INTERNAL IMPLANTSYSTEM |
5. Description of the Device
The BIOMATE Dental Implant System consists of threaded dental implants in 3.3, 4.1, 4.8, 5.5 mm diameters with 8, 10, 12, 14 mm lengths. The implants
{4}------------------------------------------------
Biomate Medical Devices Technology Co., Ltd.
are made of commercial pure titanium and coated with the laser-modified Surface. BIOMATE Dental Implant System is comprised of Bone Type Implant, Solid Abutment, Simple Abutment, Angled Abutment, Temporary Abutment, Ball Abutment, Screw, Cover Screw, Healing Abutment. The system is designed for conventional two-stage and single stage procedures for single and multiple unit prosthetics. It is intended to be used to replace missing teeth.
6. Intended Use
An endosseous dental implant is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple unit prosthetic appliance attachment to restore a patient's chewing function. lmplants can be placed with a conventional 2 stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Patients must be subject for dental treatment with endosseous implants.
7. Technological Characteristics
The threaded, root-form, bone level implants are offered in 3.3, 4.1, 4.8, 5.5 mm diameters with 8, 10, 12, 14 mm length for bone type implant. The implants are made with commercial pure titanium (ASTM F67, Grade 4) and laser- modified surface ( PDL™ Surface). There are no significant differences between Biomate Dental Implant System and the predicate devices that would adversely affect the use of the product. It is substantially equivalent to these devices in design, function, materials, operational principles and intended use.
8. Substantial Equivalence
The Biomate Dental Implant System has same intended use, technology, operation principle and technical characteristics with the predicate device(s). Design Verification activities were performed on Biomate Dental Implant System and all tests were verified to meet the required acceptance criteria. The verification tests demonstrate that the differences in the device do not affect the intended use of the device or raise any unsolved issues. There are no significant differences between Biomate Dental Implant System and the predicate device(s) that would adversely affect the use of the product. Biomate concludes that Biomate Dental Implant System is substantially equivalent to predicate devices. Comparative data is shown in Table 1.
{5}------------------------------------------------
9. Summary of Non-clinical Tests
Non- clinical tests followed the recommendations in the "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant and Endosseous Dental Implant Abutments". Tests were performed and the data demonstrate that the device is in compliance with the following standards and guidance: Biocompatibility testing- ISO 10993-3, ISO 10993-5, ISO 10993-6, ISO 10993-10, ISO 10993-11, ISO 10933-12, sterilization validation and sterility testing - ISO 11137-1, ISO 11137-2, ISO 11737-1, ISO 11737-2, and fatigue testing -ISO 14801.
10. Clinical Tests
The submission does not contain clinical data.
11. Conclusion
Biomate Dental Implant System has same intended use, technology, operation principle and technical characteristics with the predicate device(s). Based on the information and non- clinical tests provided in this premarket notification, we conclude that Biomate dental Implant System is substantially equivalent to predicate devices.
{6}------------------------------------------------
Biomate Medical Devices Technology Co., Ltd.
Table 1. Comparative Data
| Item | Predicate K070562 (primary predicate) | Predicate K073268 | Subject device |
|---|---|---|---|
| Name of device | EZ Plus Implant Systems | BioHorizons Internal Implant System | Biomate Dental Implant System |
| Classifications/ code | Class II, 872.3640, DZE | Class II, 872.3640, DZE | Class II, 872.3640, DZE |
| Prescription use | YES | YES | YES |
| Implant Type | Threaded, Screw-form/Root-formBone level | Screw-form Bone level | Threaded, Root-formBone level |
| Implant surface treatment | - | Treat with tricalcium phosphate blastmedia or hydroxylapatite coating, optionallaser surface treatment | laser surface treatment |
| Implant to abutmentconnection | Internal and External Hex | - | Internal Hex |
| Diameter (mm) | 3.3, 4.0, 5.0 | 3.5, 4.0, 5.0, 6.0 | 3.3, 4.1, 4.8, 5.5 |
| Length(mm) | 8, 10, 11, 13, 15, 18 | 9, 10.5, 12, 15 | 8, 10, 12, 14 |
| Implant Material | Commercial pure titanium | Ti-6Al-4V | Commercially pure titanium |
| Abutment Material | - | - | Commercially pure titanium |
| Abutment Angulation | 25° | - | 0, 15, 25° |
| Sterilization | Gamma | Gamma irradiation | Gamma irradiation |
| Intended Use | The EZ Plus Implant Systems areintended to be surgically placed in the | BioHorizons Internal Implants areintended for used in the mandible or | An endosseous dental implant isindicated for surgical placement in the |
{7}------------------------------------------------
| upper or lower jaw to support prostheticdevices, such as artificial teeth, and torestore a patient's chewing function. Thismay be accomplished using either a twostage surgical procedure or a single stagesurgical procedure. Large angleabutments (e.g. 25°) on small diameterimplants of the EZ Plus internalconnection system are intended for theanterior region of the mouth and notintended for use in the posterior region ofthe mouth due to limited strength of theimplant. | maxilla as artificial root structure for singletooth replacement or for fixed bridgeworkand dental retention.BioHorizons Internal Implants may berestored immediately1) with a temporary prosthesis that is notin functional occlusion, or2) when splinted together for multiple toothreplacement, or when stabilized with anoverdenture supported by multipleimplants. | upper and lower jaw arches, to providea root form means for single or multipleunit prosthetic appliance attachment torestore a patient's chewing function.Implants can be placed with aconventional 2 stage surgical processwith an option for transmucosal healingor they can be placed in a single stagesurgical process for immediate loading.It is intended for immediate loadingwhen good primary stability is achievedand with appropriate occlusal loading.Patients must be subject for dentaltreatment with endosseous implants |
|---|---|---|
| --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
§ 872.3640 Endosseous dental implant.
(a)
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.(b)
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.