(319 days)
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No
The summary describes a standard dental implant system made of titanium with a specific surface treatment. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on material properties and mechanical performance, not algorithmic accuracy.
Yes
The device, a dental implant system, aims to restore chewing function, which addresses a physiological condition (missing teeth) and improves patient health and well-being.
No
The device is a dental implant system used for restoring chewing function, not for diagnosing medical conditions.
No
The device description explicitly states that the system includes physical components such as implants, screws, and abutments made of titanium, and the performance studies involve physical tests like sterilization, shelf life, biocompatibility, corrosion, and fatigue.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical procedure for placing dental implants to restore chewing function. This is a medical device used in vivo (within the body).
- Device Description: The device is a dental implant system made of titanium, designed for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is clearly used in vivo for a surgical and restorative purpose.
N/A
Intended Use / Indications for Use
maxFiT II Dental Implant System is for single-stage or two-stage surgical procedures and cemented or screw retained restorations. maxFiT II Dental Implant System is intended for immediate placement and function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be splinted with a bar.
Product codes
DZE, NHA
Device Description
The maxFiT II Dental Implant System includes implant, screw and abutment. The maxFiT II Dental Implant System is designed for single-stage or two-stage surgical procedures and cemented or screw retained restorations.
Implant: The maxFiT II Dental Implant System consists of solid threaded, self-tapping dental implants in Ø3.5."604."70."5.6mm diameters with 8."32."34."14mm lengths. The implant of maxFiT II Dental Implant System is made from CP titanium Grade 4 which complies with ISO 5832-2 and ASTM F67. The implant surface treatment is SLA (Sand-blasted, Large grit, Acid -etched) technology which involves sandblasting with large grit and acid etching techniques, creates micron and macrosubmicron pores morphology.
Abutment Models: The abutments are made of Ti6A14V Eli, which complies with ISO 5832-3 and ASTM F136. Types of abutments include Healing Abutment, Temporary Abutment, Ball Abutment, Angled Abutment / Non-hex Angled Abutment, Transfer Abutment / Non-hex Transfer Abutment, and Locator Abutment.
Hex: The hex abutment is the external hexagonal design for preventing implant/abutment rotation. The hexagonal cone could ensure optimum stability.
Non-hex: The non-hex abutment is no anti-rotation, but it still be positioned as desired. The abutment and implant are completely friction-locked by the cone in order to prevent rotation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A series of non-clinical tests were performed:
- Sterilization Test
- Shelf Life Test
- Biocompatibility Test (In vitro Cytotoxicity Study, Intracutaneous Reactivity Study, Skin Sensitization Study, Acute Systemic Toxicity (Systemic Injection) Study, Pyrogenicity Study, In vitro Bacterial Reverse Mutation (AMES) Study, In vitro Chromosome Aberration Study, In vitro Mammalian Cell Gene Mutation Study, 14-Day Repeated Exposure Systemic Toxicity Study, 90-Day Bone Implantation Study)
- Performance Test (Corrosion test, Fatigue test)
Corrosion test: Conducted on SLA-surface treated CP4 dental implant and Ti-6Al-4V abutment, compliant with ASTM F746, ASTM F2129 and "Guidance for Industry and Staff - Class II Special Controls Guidance Document: Endosseous Dental Implants and Root-form Endosseous Dental Implant Abutments". Results proved corrosion resistance.
Fatigue test: Performed in accordance with ISO 14801 and "Guidance for Industry and Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments" to demonstrate substantial equivalence under worst-case scenario.
Key results: All test results demonstrated that maxFiT II Dental Implant System meets the requirements of its pre-defined acceptance criteria, and is substantially equivalent to the predicate device. No clinical test data was used for substantial equivalence decision.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol of three stylized human profiles facing to the right, with three wave-like lines below them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 25,2016
Taiwan Implant Technology Company, Ltd. Kaohsiung Science Park Branch Huang Ching-Chieh Assistant Manager 5f., No.63, Luke 2nd Rd., Luzhu Dist Kaohsiung, 82151 TAIWAN
Re: K151588
Trade/Device Name: maxFiT II Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: March 16, 2016 Received: March 25, 2016
Dear Huang Ching-Chieh:
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 devicerelated 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/ResourcesforYou/Industry/default.htm. 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
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,
Susan Runno DDS, MA
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
maxFiT II Dental Implant System 510(k) Notification
Indications for Use
510(k) Number (if known): K151588
Device Name: maxFiT II Dental Implant System
Indications for Use:
maxFiT II Dental Implant System is for single-stage or two-stage surgical procedures and cemented or screw retained restorations. maxFiT II Dental Implant System is intended for immediate placement and function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be splinted with a bar.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Page 1 of 1
3
maxFiT II Dental Implant System 510(k) Notification, K151588/S002
510(k) Summary
| 5.1 | Type of Submission: | Traditional |
|---|---|---|
| 5.2 | Date of Summary: | 04/19/2016 |
| 5.3 | Submitter: | Taiwan Implant Technology Company, Ltd. |
| Address: | Kaohsiung Science Park Branch | |
| 5F., No.63, Luke 2nd Rd., Luzhu Dist., | ||
| Kaohsiung City 82151, Taiwan | ||
| Phone: | +886-7-695-5561 | |
| Fax: | +886-7-695-5528 | |
| Contact: | Ching-Chieh, Huang | |
| (xjay@titc-dental.com) | ||
| Registration number: | — |
5.4 Identification of the Device:
| Proprietary/Trade name: | maxFiT II Dental Implant System |
|---|---|
| Classification Name: | Endosseous Dental Implant |
| Review Panel: | Dental |
| Regulation Number: | 872.3640 |
| Primary Product Code: | DZE |
| Secondary Product Code | NHA |
| Device Classification: | II |
ર્ રંડ Identification of the Predicate Device:
| Predicate Device Name: | ANKYLOS® C/X Dental Implant System |
|---|---|
| Manufacturer: | DENTSPLY International |
| Regulation Number: | 872.3640 |
| Product Code: | DZE |
| Device Classification: | II |
| 510(k) Number: | K083805 |
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5.6 Intended Use and Indications for Use of the subject device.
maxFiT II Dental Implant System is for single-stage or two-stage surgical procedures and cemented or screw retained restorations. maxFiT II Dental Implant System is intended for immediate placement and function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be splinted with a bar.
5.7 Device Description
The maxFiT II Dental Implant System includes implant, screw and abutment. The maxFiT II Dental Implant System is designed for single-stage or two-stage surgical procedures and cemented or screw retained restorations.
. Implant
The maxFiT II Dental Implant System consists of solid threaded, self-tapping dental implants in Ø3.5."604."70."5.6mm diameters with 8."32."34."14mm lengths. The implant of maxFiT II Dental Implant System is made from CP titanium Grade 4 which complies with ISO 5832-2 and ASTM F67. The implant surface treatment is SLA (Sand-blasted, Large grit, Acid -etched) technology which involves sandblasting with large grit and acid etching techniques, creates micron and macrosubmicron pores morphology.
Abutment Models .
The abutments are made of Ti6A14V Eli, which complies with ISO 5832-3 and ASTM F136.
| Item | Description | Specification |
|---|---|---|
| Healing Abutment | To protect the inner configuration of the implant, and help the soft tissue of gum naturally formed during the healing process. | D: 4.0mm、4.5mm、 |
| 5.0mm、5.5mm | ||
| AH: 1.0mm、3.0mm | ||
| GH: 1.0mm、2.0mm、 | ||
| 3.0mm、4.0mm、5.0mm | ||
| Temporary | ||
| Abutment | To manufacture temporary | |
| prostheses. For the temporary | ||
| crowns and bridges. The abutment | ||
| height can be modified for clinical | ||
| cases. The allowable abutment | ||
| height range is between 4.5 ~ 17mm. | ||
| And its diameter, wall thickness and | ||
| angulation cannot be modified. | D: 4.0mm、5.0mm | |
| AH: 17mm | ||
| GH: 1.0mm | ||
| Ball Abutment | Used for implant retained | |
| mucosa-supported restorations, such | ||
| as overdentures for fully edentulous | ||
| patients. | D: 4.0mm | |
| GH: 2.0mm、4.0mm | ||
| Angled Abutment / | ||
| Non-hex Angled | ||
| Abutment | Intended for use in partially or fully | |
| edentulous mandibles and maxillae, | ||
| to support for single or multiple-unit | ||
| cement retained restorations. It is | ||
| used when the prosthetic angulation | ||
| of implant correction is required for | ||
| bite direction. | D: 4.0mm、4.5mm | |
| AH: 7.0mm | ||
| GH: 2.0mm、4.0mm | ||
| Angle: 15°、25° | ||
| Type: A、B (For Angled | ||
| abutment) | ||
| Transfer | ||
| Abutment / | ||
| Non-hex Transfer | ||
| Abutment | Used as an aid in prosthetic | |
| restoration, such as cement-retained | ||
| crowns and bridges. | D: 4.0mm、4.5mm、 | |
| 5.0mm、5.5mm | ||
| AH: 4.0mm、5.5mm | ||
| GH: 1.0mm、2.0mm、 | ||
| 3.0mm、4.0mm、5.0mm、 | ||
| 6.0mm、7.0mm | ||
| Locator Abutment | Appropriate for use with | |
| overdentures or partial dentures | ||
| retained in whole or in part by | ||
| endosseous implants in the mandible | ||
| or maxilla. | D: 3.5mm | |
| H: 1.0mm、2.0mm、3.0mm | ||
| 、4.0mm、5.0mm、6.0mm |
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maxFiT II Dental Implant System 510(k) Notification, K151588/S002
| Hex | The hex abutment is the external hexagonal design for
preventing implant/abutment rotation. The hexagonal cone
could ensure optimum stability. |
|---------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Non-hex | The non-hex abutment is no anti-rotation, but it still be
positioned as desired. The abutment and implant are completely
friction-locked by the cone in order to prevent rotation. |
. Abutment connection platforms
5.8 Non-clinical Testing
A series of tests were performed on the proposed device, maxFiT II Dental Implant System.
- . Sterilization Test
- . Shelf Life Test
- . Biocompatibility Test
- In vitro Cytotoxicity Study <>
- や Intracutaneous Reactivity Study
- ゃ Skin Sensitization Study
- や Acute Systemic Toxicity (Systemic Injection) Study
- ゃ Pyrogenicity Study
- や In vitro Bacterial Reverse Mutation (AMES) Study
- ゃ In vitro Chromosome Aberration Study
- や In vitro Mammalian Cell Gene Mutation Study
- ゃ 14-Day Repeated Exposure Systemic Toxicity Study
- や 90-Day Bone Implantation Study
- Performance Test ●
- や Corrosion test
- Temporary abutment | Temporary abutment |
| Design | To manufacture temporary prostheses | To manufacture temporary prostheses |
| | For the temporary crowns and bridges | For the temporary crowns and bridges |
| Material | Titanium alloy (Ti-6Al-4V ELI, meets
ASTM F-136) | Titanium alloy (Ti-6Al-4V ELI, meets
ASTM F-136) |
| Specification | D: 4.0mm 、 5.0mm | D: 5.5mm 、 7.0mm |
| | AH: 17mm | AH: 6.0mm 、 7.5mm |
| | GH: 1.0mm | GH: 1.5mm 、 3.0mm |
| | | Angle: 0° 、 15° |
| Sterilization | Sterile _ Gamma Irradiation
Non-sterile _ Steam Sterilization by user | zirconia-reinforced PEEK |
| | Ball abutment | ANKYLOS® Snap Attachment C/ |
| Design | Implant retained mucosa-supported
restorations | Implant retained mucosa-supported
restorations |
| Material | Titanium alloy (Ti-6Al-4V ELI, meets
ASTM F-136) | Titanium alloy (Ti-6Al-4V ELI) |
| Specification | D: 4.0mm | D: 2.7mm |
| | GH: 2.0mm 、 4.0mm | GH: 1.5mm 、 3.0mm 、 4.5mm |
| Sterilization | Sterile _ Gamma Irradiation
Non-sterile _ Steam Sterilization by user | Non-sterile _ Steam Sterilization by user |
| | Angled abutment 、 Non-hex Angled
abutment | ANKYLOS Regular /X Abutment 、
ANKYLOS Regular C/ Abutment |
| Design | To support for single or multiple-unit
cement retained restorations | To support for single or multiple-unit
cement retained restorations |
| Material | Titanium alloy (Ti-6Al-4V ELI, meets
ASTM F-136) | Titanium alloy (Ti-6Al-4V ELI) |
| Specification | D: 4.0mm 、 4.5mm | D: 5.7mm |
| | AH: 7.0mm | Head height: 6.6mm 、 7.0mm 、 7.4mm |
| | GH: 2.0mm、4.0mm | 7.7mm、8.0mm |
| | Angle: 15°、25° | GH: 0.75mm、1.5mm、3.0mm、4.5mm |
| | Type: A、B (For Angled abutment) | Angle: 7.5°、15°、22.5°、30°、37.5° |
| Sterilization | Sterile _ Gamma Irradiation
Non-sterile _ Steam Sterilization by user | Non-sterile _ Steam Sterilization by user |
| | Transfer abutment、Non-hex Transfer
abutment | ANKYLOS Regular /X Abutment 、
ANKYLOS Regular C/ Abutment |
| Design | Aid in prosthetic restoration | Aid in prosthetic restoration |
| Material | Titanium alloy (Ti-6Al-4V ELI, meets
ASTM F-136) | Titanium alloy (Ti-6Al-4V ELI) |
| Specification | D: 4.0mm、4.5mm、5.0mm、5.5mm
AH: 4.0mm、5.5mm
GH: 1.0mm、2.0mm、3.0mm、4.0mm、
5.0mm、6.0mm、7.0mm | D: 5.7mm
Head height: 6.6mm
GH: 0.75mm、1.5mm、3.0mm、4.5mm |
| Sterilization | Sterile _ Gamma Irradiation
Non-sterile _ Steam Sterilization by user | Non-sterile _ Steam Sterilization by user |
| | Locator abutment | ANKYLOS LOCATOR Abutment C |
| Design | Use with overdentures or partial
dentures retained restoration | Use with overdentures or partial
dentures retained restoration |
| Material | Titanium alloy (Ti-6Al-4V ELI, meets
ASTM F-136) | Titanium alloy (Ti-6Al-4V ELI) |
| Specification | D: 3.5mm | D: 3.8mm |
| | H: 1.0mm、2.0mm、3.0mm、4.0mm、 | GH: 2.0mm、3.0mm、4.0mm、5.0mm、 |
| | 5.0mm、6.0mm | 6.0mm |
| Sterilization | Sterile _ Gamma Irradiation
Non-sterile _ Steam Sterilization by user | Non-sterile _ Steam Sterilization by user |
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maxFiT II Dental Implant System 510(k) Notification, K151588/S002
5.11 Similarity and differences
The differences between the proposed device and predicate device are the Grade of Titanium and the design of abutments connection part. The proposed device has tested on safety and performance tests and the results were complied with the test requests. Therefore, the differences of proposed device and predicate device did not raise any problems of substantial equivalence. The proposed device is substantially equivalent to the predicate device in intended use, main materials, safety and performance claims.
5.12 Conclusion
After analyzing bench tests, device description and intended use/indications for use, it can be concluded that maxFiT II Dental Implant System is substantially equivalent to the predicate device.