(256 days)
No
The summary describes a mechanical dental implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
The device is intended to restore a patient's chewing function, which is a therapeutic purpose.
No
The device description clearly states its purpose is to support prosthetic devices and restore chewing function, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly states it is a system of physical components made of Grade 4 titanium, including fixtures, screws, abutments, and accessories, intended for surgical implantation. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be placed in the jaw to support prosthetic devices and restore chewing function. This is a surgical implant for a therapeutic purpose, not a diagnostic test performed in vitro (outside the body) on biological samples.
- 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 analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
The device is a medical device, specifically a dental implant, used for treatment and restoration of function.
N/A
Intended Use / Indications for Use
The A Plus Internal Fixture System is intended to be placed in the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore a patient's chewing function. This may be accomplished using either a two stage surgical procedure or a single stage surgical procedure. It is intended for delayed loading.
Product codes
DZE, NHA
Device Description
The A Plus internal fixtures are made with Grade 4 titanium. The systems consist of one-stage and two-stage root form dental implants, associated with abutment systems, which provide the dentist with screw and cement retained restoration options.
The devices covered by this submission are A Plus internal fixture, screw, abutment and some accessories. The diameters of A Plus internal fixtures are 3.4 mm, 3.8 mm, 4.3 mm, 4.8 mm, and 5.3 mm, and the lengths are 8 mm, 10 mm, 12 mm, and 14 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper or lower jaw
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentist
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Testing:
- Sterilization Test (leveraged from own K070562 predicate)
- A Shelf Life Test (leveraged from own K052369 predicate)
- Biocompatibility testing (leveraged from own K052369 predicate):
- Cytotoxicity Test
- Intracutaneous Reactivity Test
- Maximization Sensitization Test
- Systemic Injection Test (Intravenous Injection)
- Pyrogen Test
- 90-Day Bone Implantation Study
- Performance testing: Fatigue test. The fatigue testing has been conducted on the proposed device in accordance with ISO 14801. Test results comply with ISO14801. It approves the proposed device is substantially equivalent to the predicate devices.
- RBM surface coating: The cleaning validation test and SEM/EDX analysis have been conducted on the proposed device to verify that any particles or chemicals used to remove particles have been washed from the surface.
Key results: All the test results demonstrate that A Plus Internal Fixture System meets the requirements of its pre-defined acceptance criteria and intended use. The results of non-clinical testing indicated the device was found to be substantially equivalent to the predicate devices.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The caduceus is depicted with three intertwined snakes and a pair of wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 7, 2016
T-Plus Implant Tech. Co., Ltd. Dana Cheng Quality Assurance No.41, Wuquan 6th Rd., Wugu Dist., New Taipei City, 24889 TAIWAN
Re: K152786
Trade/Device Name: A Plus Internal Fixture System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: May 9, 2016 Received: May 10, 2016
Dear Dana Cheng:
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.
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
1
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 (OS) 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
T-Plus Implant Tech. Co., Ltd. 510(k) Notification
A Plus Internal Fixture System
Indications for Use
510(k) Number (if known): K152786 A Plus Internal Fixture System Device Name:
Indications for Use:
The A Plus Internal Fixture System is intended to be placed in the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore a patient's chewing function. This may be accomplished using either a two stage surgical procedure or a single stage surgical procedure. It is intended for delayed loading.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
3
A Plus Internal Fixture System
510(k) Summary
| 5.1 | Type of Submission: | Traditional |
|---|---|---|
| 5.2 | Date of summary: | 06/06/2016 |
| 5.3 | Submitter: | T-Plus Implant Tech. Co., Ltd. |
| Address: | No.41, Wuquan 6th Rd., Wugu Dist., New | |
| Taipei City 24889, Taiwan (R.O.C) | ||
| Phone: | +886-2-22981950 | |
| Fax: | +886-2-22984353 | |
| Contact: | Dana Cheng(tplus.dana@gmail.com) |
5.4 Identification of the Device:
| Proprietary/Trade name: | A Plus Internal Fixture System |
|---|---|
| Classification Name: | Endosseous Dental Implant |
| Device Classification: | Class II |
| Review Panel: | Dental |
| Regulation Number: | 872.3640 |
| Primary Product Code: | DZE |
| Subsequent Product Code: | NHA |
5.5 Primary Predicate Device (K070562)
| Predicate Device Name: | EZ Plus Implant System |
|---|---|
| Manufacturer: | Mega'Gen Company, Limited |
| Device Classification: | Class II |
| Review Panel: | Dental |
| Regulation Number: | 872.3640 |
| Primary Product Code: | DZE |
| Subsequent Product Code: | NHA |
4
A Plus Internal Fixture System
5.6 Reference Predicate Device (K052369)
| Predicate Device Name: | ExFeel Dental Implant System |
|---|---|
| Manufacturer: | Mega'Gen Company, Limited |
| Device Classification: | Class II |
| Review Panel: | Dental |
| Regulation Number: | 872.3640 |
| Product Code: | DZE |
5.7 Intended Use and Indications for Use of the subject device
The A Plus Internal Fixture System is intended to be placed in the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore a patient's chewing function. This may be accomplished using either a two stage surgical procedure or a single stage surgical procedure. It is intended for delayed loading.
5.8 Device Description
The A Plus internal fixtures are made with Grade 4 titanium. The systems consist of one-stage and two-stage root form dental implants, associated with abutment systems, which provide the dentist with screw and cement retained restoration options.
The devices covered by this submission are A Plus internal fixture, screw, abutment and some accessories. The diameters of A Plus internal fixtures are 3.4 mm, 3.8 mm, 4.3 mm, 4.8 mm, and 5.3 mm, and the lengths are 8 mm, 10 mm, 12 mm, and 14 mm.
5
| Specification (mm) | Angulation | ||||
|---|---|---|---|---|---|
| Component | D | L | cuff H | Post H | range |
| A Plus Cover Screw | 3.15, 3.35 | 6.60, 7.10 | N/A | N/A | N/A |
| A Plus Healing Screw | 4.0, 5.0, 6.0 | 3.0, 4.0, 5.0, | |||
| 6.0, 7.0 | N/A | N/A | N/A | ||
| A Plus Abutment Screw | 2.3 | 10.8 | N/A | N/A | N/A |
| A Plus EZ Post Abutment | 4.0, 5.0, 6.0 | N/A | 1.0, 2.0, 3.0, | ||
| 4.0, 5.0 | 5.2 | N/A | |||
| A Plus Angled Abutment | 4.0, 5.0, 6.0 | N/A | 2.0, 3.0, 4.0, | ||
| 5.0 | N/A | 15°, 25° |
The range of diameters and angulations for each screw model and abutment model are provided as below:
5.9 Non-clinical Testing
A series of tests were performed to assess the proposed device is substantially equivalent to the predicate devices. All the test results demonstrate that A Plus Internal Fixture System meets the requirements of its pre-defined acceptance criteria and intended use.
-
Sterilization Test (leveraged from own K070562 predicate)
- A Shelf Life Test (leveraged from own K052369 predicate)
-
Biocompatibility testing (leveraged from own K052369 predicate):
- . Cytotoxicity Test
- . Intracutaneous Reactivity Test
- . Maximization Sensitization Test
- Systemic Injection Test (Intravenous Injection) .
- . Pyrogen Test
- . 90-Day Bone Implantation Study
6
-
Performance testing:
- Fatigue test
A fatigue test is required to evaluate the stability of implant system in oral cavity. The fatigue testing has been conducted on the proposed device in accordance with ISO 14801. Test results comply with ISO14801. It approves the proposed device is substantially equivalent to the predicate devices.
- . RBM surface coating
A Plus Internal Fixtures and the predicate devices undergo an implant surface treatment of Resorbable Blast Media (RBM). The cleaning validation test and SEM/EDX analysis have been conducted on the proposed device to verify that any particles or chemicals used to remove particles have been washed from the surface.
5.10 Clinical Testing
No additional clinical testing was necessary for a determination of substantial equivalence. The results of non-clinical testing indicated the device was found to be substantially equivalent to the predicate devices.
5.11 Substantial Equivalence Determination
The A Plus Internal Fixture System submitted in this 510(k) file is substantially equivalent in intended use, main materials, implant surface treatment, angulation range, safety and performance claims to the cleared EZ Plus Implant System (K070562) and ExFeel Dental Implant System (K052369). Differences of proposed device and predicate devices do not raise new issues of substantial equivalence.
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A Plus Internal Fixture System
| Proposed device | Predicate device | |||
|---|---|---|---|---|
| Item | A Plus Internal | |||
| Fixture System | EZ Plus Implant | |||
| System | ExFeel Dental | |||
| Implant System | ||||
| Manufacturer | T-Plus Implant Tech. | |||
| Co., Ltd. | MegaGen Co., Ltd. | MegaGen Co., Ltd. | ||
| 510(k) Number | K152786 | K070562 | K052369 | |
| Classification | Class II | Class II | Class II | |
| Intended Use | The A Plus Internal | |||
| Fixture System is | ||||
| intended to be placed | ||||
| in the upper or lower | ||||
| jaw to support | ||||
| prosthetic devices, | ||||
| such as artificial | ||||
| teeth, and to restore a | ||||
| patient's chewing | ||||
| function. This may | ||||
| be accomplished | ||||
| using either a two | ||||
| stage surgical | ||||
| procedure or a single | ||||
| stage surgical | ||||
| procedure. It is | ||||
| intended for delayed | ||||
| loading. | The EZ Plus Implant | |||
| System is intended to | ||||
| be surgically placed in | ||||
| the upper or lower jaw | ||||
| to support prosthetic | ||||
| devices, such as | ||||
| artificial teeth, and to | ||||
| restore a patient's | ||||
| chewing function. This | ||||
| may be accomplished | ||||
| using either a two | ||||
| stage or a single stage | ||||
| surgical procedure. | ||||
| Large angle abutments | ||||
| (e.g. 25°) on small | ||||
| diameter implants of | ||||
| the EZ Plus internal | ||||
| connection system are | ||||
| intended for the | ||||
| anterior region of the | ||||
| mouth and not | ||||
| intended for use in the | ||||
| posterior region of the | ||||
| mouth due to limited | ||||
| strength of the implant. | The ExFeel Dental | |||
| Implant Systems are | ||||
| intended to be placed | ||||
| in the upper or lower | ||||
| jaw to support | ||||
| prosthetic devices, | ||||
| such as artificial | ||||
| teeth, and to restore a | ||||
| patient's chewing | ||||
| function This may be | ||||
| accomplished using | ||||
| either a two stage | ||||
| surgical procedure or | ||||
| a single stage surgical | ||||
| procedure. | ||||
| Proposed device | Predicate device | |||
| Item | A Plus Internal | |||
| Fixture System | EZ Plus Implant | |||
| System | ExFeel Dental | |||
| Implant System | ||||
| Material | C.P Titanium | |||
| and Titanium Alloy | ||||
| Implant | surface | |||
| treatment | RBM | RBM | RBM | |
| Implant to | abutment | |||
| connection | Internal Hex | |||
| Connection | Internal Trip | |||
| Connection | Internal and External | |||
| Hex | ||||
| Implant Sterile | Yes | Yes | Yes | |
| Sterilization | Gamma Irradiation | Gamma Irradiation | Gamma Irradiation | |
| Implant | ||||
| size (mm) | Diameters | 3.4, 3.8, 4.3, 4.8, 5.3 | 3.3, 4.0, 5.0 | 3.75 - 5.5 |
| Lengths | 8.0, 10.0, 12.0, 14.0 | 8.0, 10.0, 11.0, 13.0, | ||
| 15.0, 18.0 | 7.0 - 18.0 |
8
Implant
Abutment model
| Proposed device | Predicate device | ||
|---|---|---|---|
| Item | A Plus Internal | ||
| Fixture System | EZ Plus Implant | ||
| System | ExFeel Dental | ||
| Implant System | |||
| Material | C.P Titanium and | ||
| Titanium Alloy | C.P Titanium and | ||
| Titanium Alloy | C.P Titanium and | ||
| Titanium Alloy | |||
| EZ Post Abutment | |||
| Diameters (mm) | 4.0, 5.0, 6.0 | 4.0, 5.0, 6.0 | 4.0, 5.0, 6.0 |
| Cuff H | 1.0, 2.0, 3.0, 4.0, 5.0 | 1.0, 2.0, 3.0, 4.0, 5.0 | - |
| Post H | 5.2 | 5.2 | - |
| Angled Abutment | |||
| Diameters (mm) | 4.0, 5.0, 6.0 | 4.0, 5.0, 6.0 | 4.0, 5.0, 6.0 |
| Cuff | 2.0, 3.0, 4.0, 5.0 | 2.0, 3.0, 4.0, 5.0 | 2.0, 4.0 |
| Angulation range | 15°, 25° | 15°, 25° | 15°, 25° |
| Sterilization | None | None | None |
9
Similarity and differences 5.12
The differences between the proposed device and the predicate devices are the design of implant to abutment connection and accessory components. The proposed device was tested, and the results complied with the pre-defined success criteria. Therefore, the differences of proposed device and predicate devices did not raise any problems of substantial equivalence. The proposed device is substantially equivalent to the predicate devices in intended use, design, safety and performance claims.
5.13 Conclusion
After analyzing bench tests, device description and intended use/indications for use, it can be concluded that A Plus Internal Fixture System is substantial equivalence to the predicate devices.