ST Internal Implant System

K190919 · T-Plus Implant Tech. Co., Ltd. · DZE · Feb 27, 2020 · Dental

Device Facts

• Record ID: K190919
• Device Name: ST Internal Implant System
• Applicant: T-Plus Implant Tech. Co., Ltd.
• Product Code: DZE · Dental
• Decision Date: Feb 27, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

ST Internal Implant System comprises root-form dental implants, abutments, and screws; used by dentists in clinical settings for tooth replacement. Implants are Grade 4 titanium with SLA (sand-blasted, large grit, acid-etched) surface treatment; abutments are Grade 4 or 5 titanium with anodized surfaces. System supports screw-retained or cement-retained restorations. Implants are placed in the jaw via single or two-stage surgery; immediate loading is permitted given sufficient primary stability. Output is a stable foundation for prosthetic devices (crowns, bridges, overdentures). Benefits include restored chewing function and dental aesthetics. Device is provided sterile (gamma irradiation) for implants; abutments require user-conducted moist heat sterilization.

Clinical Evidence

No clinical testing was performed. Substantial equivalence was established through non-clinical bench testing, including biocompatibility (cytotoxicity, sensitization, systemic toxicity, pyrogenicity), a 90-day bone implantation study, and fatigue testing per ISO 14801.

Technological Characteristics

Materials: CP Titanium Grade 4 (implants/abutments), Titanium Grade 5 (solid abutments). Surface: SLA (implants), Anodized (abutments). Connection: Internal hexagonal or circular. Sterilization: Gamma (implants), Moist heat (abutments). Dimensions: Implants 3.7-5.1mm diameter, 7.0-15.0mm length. No software or electronic components.

Indications for Use

Indicated for patients requiring dental restoration (artificial teeth) in the upper or lower jaw to restore chewing function. Suitable for single or two-stage surgical procedures. Indicated for immediate loading when good primary stability and appropriate occlusal loading are achieved.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• ST Internal Fixture System (K152787)

Reference Devices

• A Plus Internal Fixture System (K152786)
• Ti Star Implant System (K132992)
• Xpeed AnyRidge Internal Implant System (K122231)
• AnyOneTM Internal Implant System (K123988)
• CAMLOG Abutments (K083496)
• BoneTrust® Implant System (K182313)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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

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#### 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) | |
|-------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="text-decoration: underline;"></span>Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <span> <span style="text-decoration: underline;"></span>Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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# 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 |
| Email | [e-mail] |

#### Submission Correspondent 2

| Company Name | PuHsu Consulting Ltd. |
|--------------|-----------------------------------------------------------------------------|
| Address | 7F., No.272, Jiankang Rd., Zhonghe Dist.<br>New Taipei County 23553, Taiwan |
| Contact | Yuhua Chen |
| Cell Phone | 886-965650265 |
| Email | [e-mail] |

#### 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 |

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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<br>type | Diameter<br>(mm) | 3.7 |
| | Length<br>(mm) | 8.5, 10.0, 11.5, 13.0, 15.0 |
| Regular | Diameter<br>(mm) | 4.2, 4.6, 5.1 |

The characteristics of ST Internal Implant and Abutments are provided as below:

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| | <b>Implant</b> |
|---------------------|-------------------------------------------------------------------------------------------------------------|
| type<br>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<br>abutments | Diameter (mm) | 4.6, 5.0 (for Mini type)<br>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)<br>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<br>be conducted by the user before use. |
| Solid<br>abutments | Diameter (mm) | 4.0, 4.6 (for Mini type)<br>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)<br>10.4 – 15.9 (for Regular type) |
| | Design | Circular connection |
| | Material | Titanium Gr.5 |
| | Surface Treatment | Anodized |
| | Sterilization | Non-sterile. Moist heat sterilization must<br>be conducted by the user before use. |
| Cylinder<br>abutments | Diameter (mm) | 4.0, 5.0 (for Mini type)<br>4.0, 5.0, 6.0 (for Regular type) |
| | Lengths (mm) | 10.6 – 14.6 (for Mini type)<br>10.5 - 14.5 (for Regular type) |
| | Design | Hexagonal connection |

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| | | Abutments |
|---------------------|-------------------|------------------------------------------------------------------------------------|
| Item | Specification | Description |
| | Surface Treatment | Anodized |
| | Sterilization | Non-sterile. Moist heat sterilization must<br>be conducted by the user before use. |
| | Angulation range | 0° |
| Angled<br>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<br>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

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- 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.

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## 9.1 Implant, Cylinder Abutment, Angled Abutment

| | | Proposed device | Primary Predicate -1<br>T-Plus Implant Tech. Co.,<br>Ltd. | Reference Device -2<br>T-Plus Implant Tech. Co.,<br>Ltd. | Reference Device -3<br>T-Plus Implant Tech. Co.,<br>Ltd. | Reference Device -4<br>MegaGen Implant Co., Ltd. | Reference Device -5<br>MegaGen Implant Co., Ltd. | | |
|-----------------------------------|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|--------------------------------------------------------------------------|
| Feature | | ST Internal Implant System | ST Internal Fixture System<br>(K152787) | A Plus Internal Fixture<br>System<br>(K152786) | Ti Star Implant System<br>(K132992) | AnyOne™ Internal Implant<br>System<br>(K123988) | Xpeed AnyRidge Internal<br>Implant System<br>(K122231) | Comments | |
| Indication for Use | | The ST Internal Implant System<br>is intended to be placed in the<br>upper or lower jaw to support<br>prosthetic devices, such as<br>artificial teeth, and to restore a<br>patient's chewing function. This<br>may be accomplished using<br>either a two stage surgical<br>procedure or a single stage<br>surgical procedure. The ST<br>Internal Implant System is<br>intended for use for immediate<br>loading when good primary<br>stability is achieved and with<br>appropriate occlusal loading. | The ST Internal Fixture<br>System is intended to be<br>placed in the upper or lower<br>jaw to support prosthetic<br>devices, such as artificial<br>teeth, and to restore a<br>patient's chewing function.<br>This may be accomplished<br>using either a two stage<br>surgical procedure or a<br>single stage surgical<br>procedure. The ST Internal<br>Fixture System is intended<br>for use for immediate<br>loading when good primary<br>stability is achieved and<br>with appropriate occlusal<br>loading. | The A Plus Internal Fixture<br>System is intended to be<br>placed in the upper or lower<br>jaw to support prosthetic<br>devices, such as artificial<br>teeth, and to restore a<br>patient's chewing function.<br>This may be accomplished<br>using either a two stage<br>surgical procedure or a<br>single stage surgical<br>procedure. It is intended for<br>delayed loading. | The Ti Star Implant System is<br>intended to be placed in the<br>upper or lower jaw to support<br>prosthetic devices, such as<br>artificial teeth, and to restore<br>a patient's chewing function.<br>This may be accomplished<br>using either a two stage<br>surgical procedure or a<br>single stage surgical<br>procedure. The Ti Star<br>Implant System is intended<br>for use for immediate loading<br>when good primary stability<br>is achieved and with<br>appropriate occlusal loading. | The AnyOne™ Internal<br>Implant System is intended<br>to be surgically places in<br>the maxillary or mandibular<br>molar areas for the purpose<br>providing prosthetic support<br>for dental restoration<br>(Crown, bridges, and<br>overdentures) in partially or<br>fully edentulous individuals.<br>It is used to restore a<br>patient's chewing function.<br>Smaller implant (less than<br>Ø6.0mm) are dedicated for<br>immediate loading when<br>good primary stability is<br>achieved and with<br>appropriate occlusal<br>loading. Larger implants<br>are dedicated for the molar<br>region and are indicated for<br>delayed loading. | The Xpeed AnyRidge<br>Internal Implant System is<br>intended to be surgically<br>places in the maxillary or<br>mandibular molar areas for<br>the purpose providing<br>prosthetic support for<br>dental restoration (Crown,<br>bridges, and overdentures)<br>in partially or fully<br>edentulous individuals. It is<br>used to restore a patient's<br>chewing function. Smaller<br>implant (less than Ø6.0mm)<br>are dedicated for<br>immediate loading when<br>good primary stability is<br>achieved and with<br>appropriate occlusal<br>loading. Larger implants<br>are dedicated for the molar<br>region and are indicated for<br>delayed loading. | Identical to predicate<br>device 1, 2, 3 | |
| Material | | C.P Titanium | C.P Titanium | C.P Titanium and Titanium<br>Alloy | C.P Titanium and Titanium<br>Alloy | CP4 Titanium and<br>Ti-6Al-4V-ELI | CP Titanium, Gr.4 and<br>Ti-6Al-4V-ELI | Identical to predicate<br>device 1 | |
| | Implant surface treatment | SLA | RBM | RBM | RBM | SLA | SLA | Equivalent to<br>predicate device 4, 5 | |
| Implant to abutment<br>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<br>size | Diameter<br>(mm) and<br>Length (mm) | Ø 3.7 mm: 8.5, 10.0, 11.5, 13.0,<br>15.0 mm | Ø 3.5 mm: 8.5, 10.0, 11.5,<br>13.0, 15.0 mm<br>Ø 4.0 mm: 7.0, 8.5, 10.0,<br>11.5, 13.0, 15.0 mm<br>Ø 4.5 mm: 7.0, 8.5, 10.0,<br>11.5, 13.0, 15.0 mm | Ø 3.4 mm: 8.0, 10.0, 12.0,<br>14.0 mm<br>Ø 3.8 mm: 8.0, 10.0, 12.0,<br>14.0 mm | Ø 3.5 mm: 7.0, 8.5, 10.0,<br>11.5, 13.0, 15.0 mm | Normal Thread<br>Ø 3.9 mm: 7.0, 8.5, 9.5,<br>11.0, 12.5, 14.5 mm<br>Ø 4.3mm: 7.0, 8.5, 9.5,<br>11.0, 12.5, 14.5 mm | Normal Ridge<br>Ø 4.0 mm: 7.7, 9.2, 10.7,<br>12.2, 14.2, 17.2 mm | Diameters and lengths are |
| | | | Ø 4.2 mm: 7.0, 8.5, 10.0, 11.5,<br>13.0, 15.0 mm | | Ø 4.3 mm: 8.0, 10.0, 12.0,<br>14.0 mm | Ø 4.1 mm: 7.0, 8.5, 10.0,<br>11.5, 13.0, 15.0 mm | Ø 4.8 mm: 7.0, 8.5, 9.5,<br>11.0, 12.5, 14.5 mm | Ø 4.4 mm: 7.7, 9.2, 10.7,<br>12.2, 14.2, 17.2 mm | within the range of<br>predicate device 1 and 2. |
| | | | Ø 4.6 mm: 7.0, 8.5, 10.0, 11.5,<br>13.0, 15.0 mm | | Ø 4.8 mm: 8.0, 10.0, 12.0,<br>14.0 mm | Ø 4.8 mm: 7.0, 8.5, 10.0,<br>11.5, 13.0, 15.0 mm | Ø 5.3 mm: 7.0, 8.5, 9.5,<br>11.0, 12.5, 14.5 mm | Ø 4.9 mm: 7.7, 9.2, 10.7,<br>12.2, 14.2, 17.2 mm | However, the Ø<br>5.1x7.0mm is within range<br>of predicate device 4 and |
| | | | Ø 5.1 mm: 7.0, 8.5, 10.0, 11.5,<br>13.0, 15.0 mm | Ø 5.0 mm: 7.0, 8.5, 10.0,<br>11.5, 13.0, 15.0 mm | Ø 5.3 mm: 8.0, 10.0, 12.0,<br>14.0 mm | | Ø 6.3 mm: 7.0, 8.5, 9.5,<br>11.0, 12.5, 14.5 mm | Ø 5.4 mm: 7.7, 9.2, 10.7,<br>12.2, 14.2, 17.2 mm | the Ø 5.1x15.0mm is<br>within range of predicate<br>device 5. |
| | | | | | | | | Ø 5.9 mm: 7.7, 9.2, 10.7,<br>12.2, 14.2, 17.2 mm | |
| Feature | | Proposed device | Primary Predicate -1<br>T-Plus Implant Tech. Co.,<br>Ltd. | Reference Device -2<br>T-Plus Implant Tech. Co.,<br>Ltd. | Reference Device -3<br>T-Plus Implant Tech. Co.,<br>Ltd. | Reference Device -4<br>MegaGen Implant Co., Ltd. | Reference Device -5<br>MegaGen Implant Co., Ltd. | | |
| | | ST Internal Implant System | ST Internal Fixture System<br>(K152787) | A Plus Internal Fixture<br>System<br>(K152786) | Ti Star Implant System<br>(K132992) | AnyOne™ Internal Implant<br>System<br>(K123988) | Xpeed AnyRidge Internal<br>Implant System<br>(K122231) | Comments | |
| | | | | | | Ø 7.3 mm: 7.0, 8.5, 9.5,<br>11.0, 12.5, 14.5 mm<br>Deep Thread | | | |
| | | | | | | Ø 4.8 mm: 7.0, 8.5, 9.5,<br>11.0, 12.5, 14.5 mm | | | |
| | | |…