(324 days)
No
The device description and performance studies focus on the material properties, mechanical performance, and biocompatibility of the dental implant system. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is intended to restore a patient's chewing function when supporting prosthetic devices, such as artificial teeth. This direct restoration of a physiological function (chewing) makes it a therapeutic device.
No
Explanation: The device, the ST Internal Implant System, is intended to be placed in the jaw to support prosthetic devices and restore chewing function. It is a dental implant system used for treatment, not for diagnosing a condition.
No
The device description clearly states the device is made of Grade 4 titanium and includes physical components like implants, screws, and abutments.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the ST Internal Implant System is a physical implant intended to be placed in the upper or lower jaw to support prosthetic devices and restore chewing function. It is a surgical implant, not a device that analyzes samples outside the body.
The information provided describes a medical device used for surgical implantation, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The ST Internal Implant 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. The ST Internal Implant System is intended for use for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Product codes
DZE, NHA
Device Description
The ST Internal Implant System are made with Grade 4 titanium and surface treatment is done with SLA (Sand-blasted, Large grit, Acid-etched). 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 system are ST internal implant, screw and abutment. The implants in this system are provided in lengths from 7.0-15.0 and in diameters from 3.7-5.1. The 3.7 diameter implant is not provided in the 7.0 length.
The ST implants have two types, one is mini and the other is regular. The mini type diameters of ST implants are 3.7 mm and the lengths are 8.5 mm, 10.0 mm, 11.5 mm, 13.0 mm, and 15.0 mm. The regular type diameters of ST implants are 4.2 mm, 4.6 mm, and 5.1 mm, and the lengths are 7.0 mm, 8.5 mm, 10.0 mm, 11.5 mm, 13.0 mm, and 15.0 mm. EZ Post abutments, solid abutments, Cylinder abutments, angled abutments, mount screws, cover screws, abutment screws and fixture mounts are included in the system.
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)
A series of tests were performed to assess the proposed device is substantially equivalent to the predicate devices. All the test results demonstrate that ST Internal Implant System meets the requirements of its pre-defined acceptance criteria and intended use.
- Sterilization Test (leveraged from own K132992 predicate)
- Shelf Life Test (leveraged from own K132992 and K152787 predicate)
- Biocompatibility testing
- Cytotoxicity Test
- Intracutaneous Reactivity Test
- Maximization Sensitization Test
- Systemic Injection Test (Intravenous Injection)
- Pyrogen Test
- 90-Day Bone Implantation Study
- Performance testing
- Fatique 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.
- SLA surface treatment. ST Internal Implant System undergoes an implant surface treatment of Sand-blasted, Large grit, Acid-etched (SLA) which differs from the predicate devices. The cleaning validation tests 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. The SEM/EDX analysis verifies that there were no elements besides titanium found on the surface of the implant.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K152786, K132992, K122231, K123988, K083496, K182313
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.
0
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: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
February 27, 2020
T-Plus Implant Tech. Co., Ltd. % Yuhua Chen Official Correspondent PuHsu Consulting Ltd. 7F., No.272, Jiankang Rd., Zhonghe Dist. New Taipei County 23553 TAIWAN
Re: K190919
Trade/Device Name: ST Internal Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: January 20, 2020 Received: January 28, 2020
Dear Yuhua 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. 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.
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 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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190919
Device Name ST Internal Implant System
Indications for Use (Describe)
The ST Internal Implant System is intended to be placed in the upper 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.
The ST Internal Implant System is intended for use for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
| 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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3
510(k) Summary
Date prepared: February 27, 2020
Submission Submitter 1
| Company Name | T-Plus Implant Tech. Co., Ltd. |
|---|---|
| Address | No.41, Wuquan 6th Rd., Wugu Dist., |
| New Taipei County 24889, Taiwan | |
| Contact | Dana Cheng |
| Phone | 886-2-22981950 |
| Fax | 886-2-22984353 |
| danacheng@tplus.com.tw |
Submission Correspondent 2
| Company Name | PuHsu Consulting Ltd. |
|---|---|
| Address | 7F., No.272, Jiankang Rd., Zhonghe Dist. |
| New Taipei County 23553, Taiwan | |
| Contact | Yuhua Chen |
| Cell Phone | 886-965650265 |
| yuhua@puhsuconsult.com |
3 Device Name
| Proprietary/Trade Name | ST Internal Implant System |
|---|---|
| Classification Name | Endosseous dental implant |
| Device Classification | II |
| Panel | Dental |
| Regulation Number | 21 CFR 872.3640 |
| Primary Product Code | DZE |
| Secondary Product Code | NHA |
4
T-Plus Implant Tech. Co., Ltd. 510(k) K190919
Predicate Device ব
| Primary Predicate | K152787, ST Internal Fixture System |
|---|---|
| Reference Devices | K152786, A Plus Internal Fixture System |
| K132992, Ti Star Implant System | |
| K122231, Xpeed AnyRidge Internal Implant System | |
| K123988, AnyOneTM Internal Implant System | |
| K083496, CAMLOG Abutments | |
| K182313, BoneTrust® Implant System |
5 Device Description
The ST Internal Implant System are made with Grade 4 titanium and surface treatment is done with SLA (Sand-blasted, Large grit, Acid-etched). 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 system are ST internal implant, screw and abutment. The implants in this system are provided in lengths from 7.0-15.0 and in diameters from 3.7-5.1. The 3.7 diameter implant is not provided in the 7.0 length.
The ST implants have two types, one is mini and the other is regular. The mini type diameters of ST implants are 3.7 mm and the lengths are 8.5 mm, 10.0 mm, 11.5 mm, 13.0 mm, and 15.0 mm. The regular type diameters of ST implants are 4.2 mm, 4.6 mm, and 5.1 mm, and the lengths are 7.0 mm, 8.5 mm, 10.0 mm, 11.5 mm, 13.0 mm, and 15.0 mm. EZ Post abutments, solid abutments, Cylinder abutments, angled abutments, mount screws, cover screws, abutment screws and fixture mounts are included in the system.
| Implant | ||
|---|---|---|
| Specification | Description | |
| Mini | ||
| type | Diameter | |
| (mm) | 3.7 | |
| Length | ||
| (mm) | 8.5, 10.0, 11.5, 13.0, 15.0 | |
| Regular | Diameter | |
| (mm) | 4.2, 4.6, 5.1 |
The characteristics of ST Internal Implant and Abutments are provided as below:
5
| Implant | |
|---|---|
| type | |
| Length (mm) | 7.0, 8.5, 10.0, 11.5, 13.0, 15.0 |
| Design | Threaded, screw type, root-form, fixation, tapered, internal and morse taper, internal hexagonal connection |
| Material | CP Titanium Gr.4 |
| Surface Treatment | SLA |
| Sterilization | Sterile. Sterilized by Gamma irradiation. |
| Abutments | ||
|---|---|---|
| Item | Specification | Description |
| EZ Post | ||
| abutments | Diameter (mm) | 4.6, 5.0 (for Mini type) |
| 4.6, 5.0, 6.0, 7.0 (for Regular type) | ||
| Cuff Height (mm) | 0.8, 1.8, 2.8, 3.8, 4.8 | |
| Lengths (mm) | 8.5 – 14.6 (for Mini type) | |
| 8.5 – 14.5 (for Regular type) | ||
| Design | Hexagonal connection | |
| Material | CP Titanium Gr.4 | |
| Surface Treatment | Anodized | |
| Sterilization | Non-sterile. Moist heat sterilization must | |
| be conducted by the user before use. | ||
| Solid | ||
| abutments | Diameter (mm) | 4.0, 4.6 (for Mini type) |
| 4.0, 4.6, 5.0, 6.0, 7.0 (for Regular type) | ||
| Cuff Height (mm) | 0.8, 1.8, 2.8, 3.8, 4.8 | |
| Lengths (mm) | 10 – 17.0 (for Mini type) | |
| 10.4 – 15.9 (for Regular type) | ||
| Design | Circular connection | |
| Material | Titanium Gr.5 | |
| Surface Treatment | Anodized | |
| Sterilization | Non-sterile. Moist heat sterilization must | |
| be conducted by the user before use. | ||
| Cylinder | ||
| abutments | Diameter (mm) | 4.0, 5.0 (for Mini type) |
| 4.0, 5.0, 6.0 (for Regular type) | ||
| Lengths (mm) | 10.6 – 14.6 (for Mini type) | |
| 10.5 - 14.5 (for Regular type) | ||
| Design | Hexagonal connection |
6
| Abutments | ||
|---|---|---|
| Item | Specification | Description |
| Surface Treatment | Anodized | |
| Sterilization | Non-sterile. Moist heat sterilization must | |
| be conducted by the user before use. | ||
| Angulation range | 0° | |
| Angled | ||
| abutments | Diameter (mm) | 4.6, 5.0, 6.0 |
| Cuff Height (mm) | 1.0, 2.0, 3.0, 4.0 | |
| Angulation range | 15°, 25° | |
| Design | Hexagonal connection | |
| Material | CP Titanium Gr.4 | |
| Surface Treatment | Anodized | |
| Sterilization | Non-sterile. Moist heat sterilization must | |
| be conducted by the user before use. |
6 Indications for Use
The ST Internal Implant 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. The ST Internal Implant System is intended for use for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
7 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 ST Internal Implant System meets the requirements of its pre-defined acceptance criteria and intended use.
- . Sterilization Test (leveraged from own K132992 predicate)
- Shelf Life Test (leveraged from own K132992 and K152787 predicate) .
- Biocompatibility testing
- Cytotoxicity Test ●
- Intracutaneous Reactivity Test
- Maximization Sensitization Test
- Systemic Injection Test (Intravenous Injection)
- Pyrogen Test
7
- 90-Day Bone Implantation Study ●
- Performance testing
- Fatique 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.
- SLA surface treatment
ST Internal Implant System undergoes an implant surface treatment of Sand-blasted, Large grit, Acid-etched (SLA) which differs from the predicate devices. The cleaning validation tests 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. The SEM/EDX analysis verifies that there were no elements besides titanium found on the surface of the implant.
8 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.
9 Substantial Equivalence Determination
The ST Internal Implant System submitted in this 510(k) file is substantially equivalent in the design of implant to abutment connection, main materials, angulation range, safety and performance claims to the cleared ST Internal Fixture System (K152787), A Plus Internal Fixture System (K152786), Ti Star lmplant System (K132992), Xpeed AnyRidge Internal Implant System (K122231), AnyOne™ Internal Implant System (K123988), CAMLOG Abutments (K083496), and BoneTrust® Implant System (K182313). Differences between the proposed device system and the predicate device have been resolved through biocompatibility and performance testing which shows substantial equivalence of the subject device.
8
9.1 Implant, Cylinder Abutment, Angled Abutment
| | | Proposed device | Primary Predicate -1
T-Plus Implant Tech. Co.,
Ltd. | Reference Device -2
T-Plus Implant Tech. Co.,
Ltd. | Reference Device -3
T-Plus Implant Tech. Co.,
Ltd. | Reference Device -4
MegaGen Implant Co., Ltd. | Reference Device -5
MegaGen Implant Co., Ltd. | | |
|-----------------------------------|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|--------------------------------------------------------------------------|
| Feature | | ST Internal Implant System | ST Internal Fixture System
(K152787) | A Plus Internal Fixture
System
(K152786) | Ti Star Implant System
(K132992) | AnyOne™ Internal Implant
System
(K123988) | Xpeed AnyRidge Internal
Implant System
(K122231) | Comments | |
| Indication for Use | | The ST Internal Implant 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. The ST
Internal Implant System is
intended for use for immediate
loading when good primary
stability is achieved and with
appropriate occlusal loading. | The ST 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. The ST Internal
Fixture System is intended
for use for immediate
loading when good primary
stability is achieved and
with appropriate occlusal
loading. | 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 Ti Star Implant 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. The Ti Star
Implant System is intended
for use for immediate loading
when good primary stability
is achieved and with
appropriate occlusal loading. | The AnyOne™ Internal
Implant System is intended
to be surgically places in
the maxillary or mandibular
molar areas for the purpose
providing prosthetic support
for dental restoration
(Crown, bridges, and
overdentures) in partially or
fully edentulous individuals.
It is used to restore a
patient's chewing function.
Smaller implant (less than
Ø6.0mm) are dedicated for
immediate loading when
good primary stability is
achieved and with
appropriate occlusal
loading. Larger implants
are dedicated for the molar
region and are indicated for
delayed loading. | The Xpeed AnyRidge
Internal Implant System is
intended to be surgically
places in the maxillary or
mandibular molar areas for
the purpose providing
prosthetic support for
dental restoration (Crown,
bridges, and overdentures)
in partially or fully
edentulous individuals. It is
used to restore a patient's
chewing function. Smaller
implant (less than Ø6.0mm)
are dedicated for
immediate loading when
good primary stability is
achieved and with
appropriate occlusal
loading. Larger implants
are dedicated for the molar
region and are indicated for
delayed loading. | Identical to predicate
device 1, 2, 3 | |
| Material | | C.P Titanium | C.P Titanium | C.P Titanium and Titanium
Alloy | C.P Titanium and Titanium
Alloy | CP4 Titanium and
Ti-6Al-4V-ELI | CP Titanium, Gr.4 and
Ti-6Al-4V-ELI | Identical to predicate
device 1 | |
| | Implant surface treatment | SLA | RBM | RBM | RBM | SLA | SLA | Equivalent to
predicate device 4, 5 | |
| Implant to abutment
connection | | Internal Hex Connection | Internal Hex Connection | Internal Hex Connection | Internal Hex Connection | Internal Hex | Internal Hex | ldentical | |
| Implant Sterile | | Yes | Yes | Yes | Yes | Yes | Yes | ldentical | |
| Sterilization | | Gamma | Gamma | Gamma | Gamma | Gamma | Gamma | ldentical | |
| | Implant
size | Diameter
(mm) and
Length (mm) | Ø 3.7 mm: 8.5, 10.0, 11.5, 13.0,
15.0 mm | Ø 3.5 mm: 8.5, 10.0, 11.5,
13.0, 15.0 mm
Ø 4.0 mm: 7.0, 8.5, 10.0,
11.5, 13.0, 15.0 mm
Ø 4.5 mm: 7.0, 8.5, 10.0,
11.5, 13.0, 15.0 mm | Ø 3.4 mm: 8.0, 10.0, 12.0,
14.0 mm
Ø 3.8 mm: 8.0, 10.0, 12.0,
14.0 mm | Ø 3.5 mm: 7.0, 8.5, 10.0,
11.5, 13.0, 15.0 mm | Normal Thread
Ø 3.9 mm: 7.0, 8.5, 9.5,
11.0, 12.5, 14.5 mm
Ø 4.3mm: 7.0, 8.5, 9.5,
11.0, 12.5, 14.5 mm | Normal Ridge
Ø 4.0 mm: 7.7, 9.2, 10.7,
12.2, 14.2, 17.2 mm | Diameters and lengths are |
| | | | Ø 4.2 mm: 7.0, 8.5, 10.0, 11.5,
13.0, 15.0 mm | | Ø 4.3 mm: 8.0, 10.0, 12.0,
14.0 mm | Ø 4.1 mm: 7.0, 8.5, 10.0,
11.5, 13.0, 15.0 mm | Ø 4.8 mm: 7.0, 8.5, 9.5,
11.0, 12.5, 14.5 mm | Ø 4.4 mm: 7.7, 9.2, 10.7,
12.2, 14.2, 17.2 mm | within the range of
predicate device 1 and 2. |
| | | | Ø 4.6 mm: 7.0, 8.5, 10.0, 11.5,
13.0, 15.0 mm | | Ø 4.8 mm: 8.0, 10.0, 12.0,
14.0 mm | Ø 4.8 mm: 7.0, 8.5, 10.0,
11.5, 13.0, 15.0 mm | Ø 5.3 mm: 7.0, 8.5, 9.5,
11.0, 12.5, 14.5 mm | Ø 4.9 mm: 7.7, 9.2, 10.7,
12.2, 14.2, 17.2 mm | However, the Ø
5.1x7.0mm is within range
of predicate device 4 and |
| | | | Ø 5.1 mm: 7.0, 8.5, 10.0, 11.5,
13.0, 15.0 mm | Ø 5.0 mm: 7.0, 8.5, 10.0,
11.5, 13.0, 15.0 mm | Ø 5.3 mm: 8.0, 10.0, 12.0,
14.0 mm | | Ø 6.3 mm: 7.0, 8.5, 9.5,
11.0, 12.5, 14.5 mm | Ø 5.4 mm: 7.7, 9.2, 10.7,
12.2, 14.2, 17.2 mm | the Ø 5.1x15.0mm is
within range of predicate
device 5. |
| | | | | | | | | Ø 5.9 mm: 7.7, 9.2, 10.7,
12.2, 14.2, 17.2 mm | |
| Feature | | Proposed device | Primary Predicate -1
T-Plus Implant Tech. Co.,
Ltd. | Reference Device -2
T-Plus Implant Tech. Co.,
Ltd. | Reference Device -3
T-Plus Implant Tech. Co.,
Ltd. | Reference Device -4
MegaGen Implant Co., Ltd. | Reference Device -5
MegaGen Implant Co., Ltd. | | |
| | | ST Internal Implant System | ST Internal Fixture System
(K152787) | A Plus Internal Fixture
System
(K152786) | Ti Star Implant System
(K132992) | AnyOne™ Internal Implant
System
(K123988) | Xpeed AnyRidge Internal
Implant System
(K122231) | Comments | |
| | | | | | | Ø 7.3 mm: 7.0, 8.5, 9.5,
11.0, 12.5, 14.5 mm
Deep Thread | | | |
| | | | | | | Ø 4.8 mm: 7.0, 8.5, 9.5,
11.0, 12.5, 14.5 mm | | | |
| | | | | | | Ø 5.8 mm: 7.0, 8.5, 9.5,
11.0, 12.5, 14.5 mm | | | |
| | | | | | | Ø 6.8 mm: 7.0, 8.5, 9.5,
11.0, 12.5, 14.5 mm | | | |
| | | | | | | Ø 7.8 mm: 7.0, 8.5, 9.5,
11.0, 12.5, 14.5 mm | | | |
| | | | | | | Ø 8.3 mm: 7.0, 8.5, 9.5,
11.0, 12.5, 14.5 mm | | | |
| Cylinder
Abutment | Diameter
(mm) | 4.0, 5.0, 6.0 | - | - | - | 3.8 – 10.0 | - | Diameters are within
range of predicate device
4 | |
| size | Length (mm) | 10.5 – 14.6 | - | - | - | 7.7 - 18.7 | - | Length are within range of
predicate device 4 | |
| Angled
Abutment
size | Diameter
(mm) | 4.6, 5.0, 6.0 | 4.0, 5.0, 6.0 | 4.0, 5.0, 6.0 | - | 3.8 – 10.0 | - | Diameters are within
range of predicate device
1 | |
| | Cuff Height
(mm) | 1.0, 2.0, 3.0, 4.0 | 1.0, 2.0, 3.0, 4.0, 5.0 | 2.0, 3.0, 4.0, 5.0 | - | - | - | Cuff heights are within
range of predicate device
1 | |
| | Angulation
range | 15°, 25° | 15°, 25° | 15°, 25° | - | 15°, 25° | - | Identical to predicate
device 1, 2, 4 | |
ST Internal Implant System
9
9.2 EZ Post Abutment
| Feature | Proposed device
ST Internal Implant System | Primary Predicate -1
T-Plus Implant Tech. Co., Ltd.
ST Internal Fixture System
(K152787) | Reference Device -2
Altatec GmbH
CAMLOG Abutments
(K083496) | Reference Device -3
Medical Instinct Deutschland GmbH
BoneTrust® Implant System
(K182313) | |
|------------------|-------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|----------|
| Material | CP Titanium Gr.4 | CP Titanium Gr.4 | Titanium alloy TiAl4V | Titanium alloy TiAl4V | Identic |
| Surface | Anodized surface | Anodized surface | Anodized surface | Anodized surface | Identic |
| Diameter (mm) | 4.6, 5.0 (for Mini type)
4.6, 5.0, 6.0, 7.0 (for Regular type) | 4.0, 5.0, 6.0, 7.0 | 3.8, 4.3, 5.0, 6.0 | 3.4, 4.0, 5.0 | Diameter |
| Cuff Height (mm) | 0.8, 1.8, 2.8, 3.8, 4.8 | 1.0, 2.0, 3.0, 4.0, 5.0 | 0.8, 1.5 | 0.5, 0.7, 2.5, 4.5 | The m |
| Connection | Hexagonal connection | Hexagonal connection | Conical fitting | Cylindrical external Hexagon
or and conical torx | Identic |
| Angulation range | 0° | 0° | 0°, 15°, 20° | 0°, 15°, 20° | Identic |
Comments
cal to predicate device 1
cal
eters are within range of predicate
e 1
minimum length is identical to
cate device 2 and bigger than device
cate device 2 and bigger than device
predicate device 1.
cal to predicate device 1
cal to predicate device 1
10
9.3 Solid Abutment
| Feature | Proposed device | Primary Predicate -1
T-Plus Implant Tech. Co., Ltd. | Reference Device -2
Altatec GmbH | Reference Device -3
Medical Instinct Deutschland GmbH |
|------------------|---------------------------------------------------------------------------|--------------------------------------------------------|-------------------------------------|----------------------------------------------------------|
| | ST Internal Implant System | ST Internal Fixture System
(K152787) | CAMLOG Abutments
(K083496) | BoneTrust® Implant System
(K182313) |
| Material | Titanium Gr.5 | Titanium Gr.5 | Titanium alloy TiAl4V | Titanium alloy TiAl4V |
| Surface | Anodized surface | Anodized surface | Anodized surface | Anodized surface |
| Diameter (mm) | 4.0, 4.6 (for Mini type)
4.0, 4.6, 5.0, 6.0, 7.0 (for Regular
type) | 4.0, 4.5, 5.0, 6.0, 7.0 | 3.8, 4.3, 5.0, 6.0 | 3.4, 4.0, 5.0 |
| Cuff Height (mm) | 0.8, 1.8, 2.8, 3.8, 4.8 | 1.0, 2.0, 3.0, 4.0, 5.0 | 0.8, 1.5 | 3.0 |
| Connection | Circular connection | Circular connection | Conical fitting | Cylindrical external Hexagon
or and conical torx |
| Angulation range | 0° | 0° | 0°, 15°, 20° | 0° |
Comments
ical to predicate device 1 ical
leters are within range of predicate
ce 1
minimum length is identical to
cate device 2, and the maximum
h is smaller than predicate device 1.
ical to predicate device 1
ical to predicate device 1 and 3
11
10 Similarity and differences
The differences between the proposed device and the predicate devices are accessory components, and implant surface treatment. 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.
11 Conclusion
After analyzing bench tests, device description and intended use/indications for use, it can be concluded that ST Internal Implant System is substantially equivalent to the predicate devices.