DenQ Sub SLA Implant System

K240977 · Denq · DZE · Sep 13, 2024 · Dental

Device Facts

• Record ID: K240977
• Device Name: DenQ Sub SLA Implant System
• Applicant: Denq
• Product Code: DZE · Dental
• Decision Date: Sep 13, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DenQ Sub SLA Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.

Device Story

DenQ Sub SLA Implant System consists of titanium dental implants and various abutments; intended for surgical placement in upper or lower jaw bone. Implants feature internal hex connection, tapered or tapered-straight body, and SLA (sand-blasted, large-grit, acid-etched) surface. Abutments include healing, solid, cement, angled, temporary, and multi-unit types; some feature TiN coating. System used by dentists/oral surgeons in clinical settings for prosthetic restoration. Implants supplied sterile; abutments supplied non-sterile. Device supports single/multiple-unit restorations and fixed bridgework. Clinical benefit includes restoration of chewing function and aesthetics for edentulous patients. Provider uses output (implant/abutment assembly) to anchor dental prostheses.

Clinical Evidence

No clinical data. Bench testing only: Gamma sterilization validation (ISO 11137), shelf-life validation (ASTM F1980, F1140, F2096, F88), BET validation (USP <85><161>), user sterilization validation (ISO 17665), biocompatibility (ISO 10993), fatigue testing (ISO 14801), shear testing (ASTM F1044), tension testing (ASTM F1147), and surface analysis (SEM/EDS).

Technological Characteristics

Materials: CP Titanium Grade 4 (ASTM F67-13) and Ti 6Al 4V ELI (ASTM F136-13). Surface: SLA (sand-blasted, large-grit, acid-etched). Connection: Internal hex. Design: Bone-level, tapered/tapered-straight body, self-tapping. Abutments: Various types (healing, solid, cement, angled, temporary, multi-unit, FreeMilling), some with TiN coating. Sterilization: Gamma (fixtures), user-sterilized (abutments).

Indications for Use

Indicated for partially or fully edentulous mandibles and maxillae in patients requiring single or multiple-unit restorations (cemented, screw-retained, or overdenture) or terminal/intermediate abutment support for fixed bridgework. Suitable for one or two-stage surgical procedures with delayed loading.

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

• IH Implant System, Sewon Medix Inc. (K222707)

Reference Devices

• TS Fixture System, OSSTEM Implant Co., Ltd. (K121995)
• Tatum Surgical Dental Implant System, Suncoast Dental, Inc. dba Tatum Surgical (K213576)
• Straumann® BLC and TLC Implants, Straumann USA, LLC (K230108)
• IH Implant System, Sewon medix Inc. (K153521)

Submission Summary (Full Text)

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September 13, 2024

DenQ Taehoon Lee Representative 302, PNU Hyowon Industry-Academic Cooperation Hall, 2, Busandaehak-ro, Geumjeong-gu Busan, 46241 REPUBLIC OF KOREA

Re: K240977

Trade/Device Name: DenQ Sub SLA Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: August 14, 2024 Received: August 14, 2024

Dear Taehoon Lee:

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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

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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.

# Andrew I. Steen -S

Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT 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

Submission Number (if known)

K240977

Device Name

DenQ Sub SLA Implant System

#### Indications for Use (Describe)

The DenQ Sub SLA Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed 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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Image /page/4/Picture/0 description: The image shows the logo for DenQ Implant. The logo is pink and features the word "DenQ" in a stylized font. Below the word "DenQ" is the word "IMPLANT" in a smaller, sans-serif font. The logo is simple and modern, and the pink color gives it a friendly and approachable feel.

# 1. 510(k) Summary

Submitter DENQ TAEHOON LEE 302, PNU Hyowon Industry-Academic Cooperation Halll, 2, Busandaehak-ro 63Beon-gil, Gumjeong-gu, Busan, Republic of Korea Tel: [phone] Email: [e-mail]

### Device Information

Trade Name: DenQ Sub SLA Implant System Common Name: Endosseous Dental Implant Classification Name: Implant, Endosseous, Root-Form Product Code: DZE Secondary Product Code: NHA Regulation Number: 872.3640 Device Class: Class II Date Prepared: 09/13/2024

# Predicate Device(s) Primary Predicate Device

- K222707-IH Implant System, Sewon Medix Inc. ●
#### Reference Devices

- K121995-TS Fixture System, OSSTEM Implant Co., Ltd. ●
- K213576-Tatum Surgical Dental Implant System, Suncoast Dental, Inc. dba Tatum Surgical
- K230108-Straumann® BLC and TLC Implants, Straumann USA, LLC
- K153521-IH Implant System, Sewon medix Inc. ●

#### Description

The DenQ Sub SLA Implant System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. This implant system has internal hex connection, tapered with straight body and bone level that are similar to other commercial available products based on the intended use, technology used, the material composition employed and performance characteristics. This DenQ Sub SLA fixture of implant system is supplied sterile.

The DenQ Sub SLA Implant System diameter and lengths are below:

- The DenQ Sub SLA Fixtures

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Image /page/5/Picture/0 description: The image shows the logo for DenQ Implant. The logo is pink and features the word "DenQ" in a stylized font. Below the word "DenQ" is the word "IMPLANT" in a smaller, sans-serif font. The logo is simple and modern, and the pink color gives it a friendly and inviting feel.

| Product<br>name | Division | Platform Diameters<br>(Fixture Diameter) | Body Diameters | Lengths |
|-----------------|----------|------------------------------------------|----------------|--------------------------------------|
| Fixture I | Regular | Ø3.75, Ø3.77 | - | 7, 7.5, 8, 8.5, 9,<br>9.5, 10, 10.5, |
| | Regular | Ø4.25 | - | 11, 11.5, 12, |
| | Regular | Ø4.6, Ø4.63, Ø4.65 | - | 12.5, 13, 13.5, |
| | Regular | Ø5.05, Ø5.08. Ø5.1 | - | 14, 14.5, 15 mm |
| Fixture I | Wide | Ø5.95 | - | |
| Fixture I | Wide | Ø6.8 | - | |
| Fixture II | Regular | Ø4.21 | Ø4.0 | 7, 7.5, 8, 8.5, 9,<br>9.5, 10, 10.5, |
| | Regular | Ø4.67 | Ø4.5 | 11, 11.5, 12, |
| | Regular | Ø5.14 | Ø5.0 | 12.5, 13, 13.5, |
| Fixture II | Wide | Ø6.2 | Ø5.0 | 14 mm |
| Fixture II | Wide | Ø6.8 | Ø5.8 | |
| Fixture III | Regular | Ø4.25 | - | 7, 7.5, 8, 8.5, 9,<br>9.5, 10, 10.5, |
| | Regular | Ø4.6, Ø4.63, Ø4.65 | - | 11, 11.5, 12, |
| | Regular | Ø5.05, Ø5.08. Ø5.1 | - | 12.5, 13, 13.5, |
| Fixture III | Wide | Ø5.95 | - | 14 mm |
| Fixture III | Wide | Ø6.8 | - | |

Internal Hex-connected, Bone level fixture, Tapered and Tapered-Straight body Implant Fixture Dimension:

The fixture is made of Pure Titanium Grade 4. The surface is treated by Sand -blasting (Large grit) and acid etching method (SLA). This system only contains the implant bodies with cover screw and are provided as a set-packing.

The DenQ Sub Abutments are device made of cp titanium grade 4 and titanium alloy intended for use as a Prosthetic restoration. It consists of Abutments(Healing, Solid, Cement, Angled, Temporary, Multi-unit Straight, Multi-unit Angled, Multi-unit Healing Cap, Multiunit Ti Cylinder, Multi-unit Temporary Cylinder and FreeMilling). The TiN coating is applied to some abutment, which are solid Abutment, Cement Abutment and Angled Abutment. They have various diameter, height(Length), gingiva height, post height and angled. The Healing Abutment has various diameter 4, 4.5, 5.0, 5.5, 6.0, 6.5 and 7.0, Lengths 8.4, 9.4, 10.4, 11.4 and 12.4mm. The Solid Abutment packaging is only abutment that has various diameters 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 and 7.0, gingiva height 0.5, 1, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5 and 5mm, post height 4, 5.5 and 7mm. The Cement Abutment has various diameters 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 and 7.0, gingiva height 0.5, 1, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5 and 5mm, post height 4. 5.5 and 7mm. The Angled Abutment has post angled 15°, 17°, 20° and 25°. Its packaging is Abutment with Abutment screw and it has hex and non-hex type. The angle abutment has diameter 4.0, 4.5, 5.0, 5.5 and 6.0mm, gingiva height 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5 and 5.0mm, post height 8mm. It has hex and non-hex, hex type of a and b that a type is same path for post height with hex's edge and b type is same path for hex's plat with post height. Its packaging is abutment with abutment screw as a set packaging. The temporary abutment has diameter 4.0, 4.5, 5.0, 5.5 and 6.0mm, gingiva height 0.5, 1.0, 1.5, 2.0, 2.5 and 3.0mm, height 12.6, 13.1, 13.6, 14.1, 14.6, 15.1 and 12.85, 13.35, 13.85, 14.35, 14.85 and 15.35. Its packaging unit is abutment with abutment screw as a set. The multi-unit Abutment consist straight and angled type and straight type has diameter 4.8, 5.0 and 5.5mm, gingiva height 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 4.5 and 5.0mm, the hex of abutment 2.0mm, hex height 2.2mm. And angled type has diameter 4.71, 4.92, 5.04, 5.4 and

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Image /page/6/Picture/0 description: The image shows the logo for DenQ Implant. The logo is pink and features the word "DenQ" in a stylized font. Below the word "DenQ" is the word "IMPLANT" in a smaller, sans-serif font. The logo is simple and modern, and the pink color gives it a friendly and approachable feel.

5.5mm, angle 15°, 17°, 20° and 30°, gingiva height 1.0, 2.0, 2.5, 3.0, 3.5, 4.0 and 4.5. Its packaging unit is abutment with abutment screw as a set. It has hex and non-hex. The multiunit healing cap has various diameter 4.5, 4.8, 5.0 and 5.5mm, height 4.8 and 5.0mm. The multi-unit Ti cylinder has diameter 4.5, 4.8, 5.0 and 5.5mm, post height 4.1, 5.6 and 7.1mm. Its packaging unit is Ti cylinder with cylinder screw as a set. The multi-unit temporary cylinder has various diameter 4.5, 4.8, 5.0 and 5.5mm. length 12mm. Its packaging unit is temporary abutment with cylinder as a set. The FreeMilling abutment has various diameter 4.5, 5.0, 5.5 and 6.0mm, gingiva height 1, 2, 3, 4 and 5mm, length 15.5 and 15.75mm. It has hex and non-hex and packaging unit is abutment with abutment screw. It is used by hand milling. Its packaging unit is abutment with abutment screw as a set.

Healing Abutment, Temporary Abutment, Multi-unit Abutment and Temporary Abutment are uncoating applied. All Abutment is supplied non-sterilized and should be sterilized before use as given conditions of manufacturer.

#### Indication for Use

The DenQ Sub SLA Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.

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Image /page/7/Picture/0 description: The image shows the logo for DenQ Implant. The logo is pink and features the word "DenQ" in a stylized font. Below the word "DenQ" is the word "IMPLANT" in smaller, sans-serif letters. The logo is simple and modern.

#### Predicate Device and reference devices & Comparison of Fixture

The subject device is substantially equivalent to the following predicate device and reference devices:

- · K222707, IH Implant System by Sewon Medix Inc. Primary predicate device
- K121995, TS Fixture System by Osstem Implant Co., Ltd. Reference device .
- K213576, Tatum Surgical Dental Implant System by Suncoast Dental, Inc. dba Tatum Surgical. Reference device
- · K230108, Straumann® BLC and TLC Implants by Straumann USA, LLC Reference device

| Division | Subject Device | Primary Predicate<br>device | Reference device | | |
|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | DenQ Sub SLA<br>Implant System | IH Implant System | TS Fixture System | Tatum Surgical<br>Dental Implant<br>System | Straumann® BLC and<br>TLC Implants |
| 510(k)<br>Number | K240977 | K222707 | K121995 | K213576 | K230108 |
| Manufacturer | DenQ Co., Ltd. | Sewon Medix Inc. | Osstem Implant Co.,<br>Ltd. | Suncoast Dental, Inc.<br>dba Tatum Surgical | Straumann USA, LLC |
| Reason for<br>primary and<br>Reference<br>device | N/A | Major technological<br>characteristics | Implant body shape,<br>wide diameter(Ø6.2,<br>6.8) and<br>length(7~12.5mm) | Implant wide<br>diameter(Ø6.0, 7.0)<br>and length(13~15mm) | Basic surface<br>treatment, implant<br>body diameter and<br>length |
| Indication for<br>use | The DenQ Sub SLA<br>Implant System is<br>indicated for use in<br>partially or fully<br>edentulous mandibles<br>and maxillae, in<br>support of single or<br>multiple unit<br>restorations including; | IH Implant System is<br>device made of<br>titanium and titanium<br>alloy indicated for in<br>partially or fully<br>edentulous mandibles<br>and maxillae, in<br>support of single or<br>multiple-unit | The TS Fixture<br>System is indicated for<br>use in partially or full<br>edentulous mandibles<br>and maxillae, in<br>support of single or<br>multiple-unit<br>restorations including;<br>cemented retained. | The Tatum Surgical<br>Integrity Tapered, "T"<br>and “S” Dental<br>Implant Systems are<br>intended to be<br>surgically placed in<br>the bone of the upper<br>or lower jaw to<br>provide support for | Straumann® dental<br>implants are indicated<br>for the functional and<br>esthetic oral<br>rehabilitation of the<br>upper or lower jaw of<br>edentulous or partially<br>edentulous patients.<br>They can be used for |
| | cemented retained, or<br>screw retained, or<br>overdenture<br>restorations, and<br>terminal or<br>intermediate abutment<br>support for fixed<br>bridgework. This<br>system is dedicated for<br>one and two stage<br>surgical procedures.<br>This system is<br>intended for delayed<br>loading. | restorations including;<br>cemented retained or<br>screw retained<br>restorations and<br>terminal or interminal<br>abutment support for<br>fixed bridgework. IH<br>Implant System is for<br>single and two stage<br>surgical procedures. It<br>is intended for delayed<br>loading. | screw retained, or<br>overdenture<br>restorations; and final<br>or temporary abutment<br>support for fixed<br>bridgework. It is<br>intended for delayed<br>loading. | removable or fixed<br>prosthesis to restore<br>chewing function. It<br>may be used with<br>single-stage or two-<br>stage procedures, for<br>single or multiple unit<br>restorations, and may<br>be loaded immediately<br>when good primary<br>stability is achieved<br>and with appropriate<br>occlusal loading. | immediate, early or<br>late implantation<br>following the<br>extraction or loss of<br>natural teeth. The<br>implants can be placed<br>with immediate<br>function for single-<br>tooth and/or multiple-<br>tooth restorations<br>when good primary<br>stability is achieved<br>and with appropriate<br>occlusal loading to<br>restore chewing<br>function. |
| Material | CP Titanium Gr.4<br>(ASTM F67-13) | CP Titanium Gr.4<br>(ASTM F67-13) | CP Titanium Gr.4<br>(ASTM F67-13) | Ti 6Al 4V<br>(ASTM F136-13) | Titanium-13<br>Zirconium alloy<br>(Roxolid®) |
| Design<br>(Fixture<br>Type) | Image: Fixture I | Image: Mini | Image: TSII SA Fixture | Image: Ti 6Al 4V | Image: Titanium-13 Zirconium alloy |
| Fixture<br>Diameter | Fixture I<br>Reg.: Ø3.75, Ø3.77,<br>Ø4.25, Ø4.6, Ø4.63 | Mini: Ø3.7<br>Reg.: Ø3.8, Ø4.2,<br>Ø4.5, Ø5.0, Ø5.95 | TSII SA Fixture<br>Ø3.5, Ø4.2, Ø4.4,<br>Ø4.9<br>TSIII SA Fixture | Ø3.7, 4.0, Ø4.5, Ø5.0,<br>Ø6.0, Ø7.0, Ø8.0 | Ø3.3, Ø3.75, Ø4.5,<br>Ø5.5, Ø6.5 |
| | Ø4.65, Ø5.05, Ø5.08,<br>Ø5.1<br>Wide: Ø5.95, Ø 6.8<br>Fixture II<br>Reg.: Ø4.21, Ø4.67,<br>Ø5.14<br>Wide: Ø6.2, Ø6.8<br>Fixture III<br>Reg.: Ø4.25, Ø4.6,<br>Ø4.63, Ø4.65, Ø5.05,<br>Ø5.08, Ø5.1<br>Wide: Ø5.95, Ø 6.8 | | Ø3.75, Ø3.77, Ø4.2,<br>Ø4.25, Ø4.6, Ø4.63,<br>Ø4.65, Ø5.05, Ø5.08,<br>Ø5.1<br>TSIII SA Ultra-Wide<br>Fixture<br>Ø5.92, Ø5.95, Ø6,<br>Ø6.8 | | |
| Fixture<br>Length | Fixture I<br>7~15mm<br>Fixture II, III<br>7~14 mm | 7.0, 8.5, 10, 11.5, 13,<br>15 mm | TS Fixture<br>7~15 mm<br>TS III SA Ultra-Wide<br>Fixture<br>7~12.5 mm | 9, 11, 14, 17, 20 mm<br>(no 20 mm length for<br>Ø7 and 8 mm) | BLC: Ø3.3: 8~18mm<br>Ø3.75 and Ø4.5:<br>6~18mm<br>Ø5.5: 6~16mm<br>Ø6.5: 6~14mm<br>TLC: Ø3.3, Ø3.75<br>and Ø4.5 of BLC are<br>same<br>Ø5.5: 6~12mm<br>Ø6.5: 6~10mm |
| Structure | - Internal Hex-<br>connected<br>-Bone level<br>- Tapered & straight<br>body shape<br>- Cutting edge with<br>self-tapping<br>- 0.8mm thread pitch | - Internal Hex-<br>connected<br>-Bone level<br>- Tapered body shape<br>- Cutting edge with<br>self-tapping<br>- 0.8mm thread pitch | - Internal Hex-<br>connected<br>-Bone level<br>- Tapered body shape<br>and straight body<br>shape<br>- 4 sided cutting edge<br>with self-tapping | - Tissue or Bone<br>Level<br>- Threaded<br>- Tapered body<br>- Root-form implant | Apically tapered<br>Bone Level<br>implant |

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Image /page/8/Picture/0 description: The image shows the logo for DenQ Implant. The logo is pink and features the word "DenQ" in a stylized font. Below the word "DenQ" is the word "IMPLANT" in smaller, gray letters. The logo is simple and modern.

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Image /page/9/Picture/0 description: The image shows the logo for DenQ Implant. The logo is pink and features the word "DenQ" in a stylized font. Below the word "DenQ" is the word "IMPLANT" in a smaller, sans-serif font. The "Q" in "DenQ" is stylized to look like a spiral.

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Image /page/10/Picture/4 description: The image shows the logo for DenQ Implant. The logo is pink and features the word "DenQ" in a stylized font. Below the word "DenQ" is the word "IMPLANT" in smaller, sans-serif letters. The logo is simple and modern.

| Connection<br>type | Internal hex<br>connection | Internal hex<br>connection | Internal hex<br>connection | Internal Pentagon<br>connection | TorcFit(with conical<br>fitting) | |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|----------------------------|------------------------------------------|--------------------------------------|--|
| Surgery type | One or two stage | One or two stage | One or two stage | One or two stage | One or two stage | |
| Surface<br>Treatment | SLA | SLA | SA(SLA) | Aluminum oxide<br>blasted and passivated | Hydrophilic<br>SLActive® and<br>SLA® | |
| Gamma<br>Sterilized | Yes | Yes | Yes | Yes | Yes | |
| Product Code | DZE, NHA | DZE, NHA | DZE | DZE, NHA | DZE | |
| Shelf Life | 5 years | 5 years | 8 years | 5 years | 5 years | |
| S.E | The Indication for use of DenQ Sub SLA Implant System is similar to the primary predicate device as K222707. Also,<br>the indication for use of reference devices K121995, K213576 and K230108 are the similar to the Subject device. The<br>DenQ Sub SLA Implant System has taper body of fixture I, III and taper-straight-taper body shape of fixture II. The<br>DenQ Sub SLA Implant System has the similar raw material, surface treatment, surgical type, sterilization method, shelf-<br>life, connection structure, implant basic components and product code as primary predicate device K222707. The<br>difference between the Subject device and primary predicate device are their similar implant body shape, implant<br>diameter, and length. The implant shape and configuration were similar to the primary predicate device and reference<br>device, with bone level, tapered and straight body, cutting edge, and self-tapping structures. The Subject device has<br>tapered body and tapered-straight-tapered body shapes, but the primary device K222707 has only tapered body shape.<br>However, the reference device K121995 has an implant body shape with tapered and straight body shapes, and the body<br>shape of subject device and reference device K121995 are very similar. The implant diameter of subject device ranges<br>from Ø3.75 to Ø6.8(Ø3.88, Ø3.9 of Fixture II and Ø3.77 of Fixture III are not available), and these diameters have a<br>similar range to the diameter of primary predicate device. However, implant diameters of Ø6.2 and Ø6.8 are not included<br>in the primary predicate device. The implant diameters Ø6.2 and Ø6.8 are similar to the reference device K122995 wide<br>implant Ø6.0 and Ø6.2 of implant diameter of subject device, and the subject device Ø6.8 diameter is similar to Ø6.8<br>diameter of reference device K122995. The implant length of the Subject device is 7~15mm, and the implant length of<br>the primary predicate device is 7~15mm, but Ø5.95 is 7~13mm and there is no 15mm. The implant lengths of Subject<br>device Ø6.2 and Ø6.8x7~15mm are similar to Ø5.92, Ø5.95, Ø6.8x7~12.5mm in reference device K121995. The implant | | | | | |

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Image /page/11/Picture/0 description: The image shows the logo for DenQ Implant. The logo is pink and features the word "DenQ" in a stylized font. Below the word "DenQ" is the word "IMPLANT" in smaller, sans-serif letters. The "Q" in "DenQ" is designed to look like a spiral.

lengths of Subject device Ø5.95x15mm, Ø6.2 and Ø6.8x13~15mm are similar to the Ø6.0, Ø7.0x11~17mm of the reference device K213576. The subject device consists of an implant body with a diameter of 3.7 to 6.8, and the K230108 consists of an implant body with a diameter of 3.3 to 6.5, which constitute implant body diameters similar to those of the subject device and K230108. The Subject device has sand blasting surface it is similar primary device K222707 and the basic surface treatment method is the similar as the reference device K230108.

#### Reference Devices & Comparison of Abutment

The subject device is substantially equivalent to the following reference device:

- · K153521, IH Implant System by Sewon Medix Inc. Reference device

| Division | Subject Device | Reference Device |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | DenQ Sub SLA Implant System | IH Prosthetic System |
| 510(k) Number | K240977 | K153521 |
| Manufacturer | DenQ Co., Ltd. | Sewon Medix Inc. |
| Indication for use | The DenQ Sub SLA Implant System is indicated<br>for use in partially or fully edentulous mandibles<br>and maxillae, in support of single or multiple unit<br>restorations including; cemented retained, screw<br>retained, or overdenture restorations, and terminal<br>or intermediate abutment support for fixed<br>bridgework. This system is dedicated for one and<br>two stage surgical procedures. This system is<br>intended for delayed loading. | IH Implant System is device made of titanium and<br>titanium alloy indicated for in partially or fully<br>edentulous mandibles and maxillae, in support of single<br>or multiple-unit restorations including ; cemented<br>retained or screw retained restorations and terminal or<br>interminal abutment support for fixed bridgework. IH<br>Implant System is for single and two stage surgical<br>procedures. It is intended for delayed loading. |
| Material | Ti 6Al 4V ELI<br>(ASTM F136-13)<br>Healing, Solid, Cement, Multi-unit<br>CP Titanium Gr4<br>(ASTM F67-13)<br>Angled, Temporary, FreeMilling | Ti 6Al 4V ELI<br>(ASTM F136)<br>Healing, Solid, Cement, Multi-unit<br>CP Titanium Gr4<br>(ASTM F67-13)<br>Angled, Temporary, FreeMilling |

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Image /page/12/Picture/0 description: The image shows the logo for DenQ Implant. The logo is pink and features the word "DenQ" in a stylized font. Below the word "DenQ" is the word "IMPLANT" in a smaller, sans-serif font. The "Q" in "DenQ" is stylized to look like a spiral.

Image /page/12/Figure/2 description: The image shows a table with different designs of abutments. The designs are Healing, Solid, Cement, Angled, and Temporary. Each design has two different images of the abutment. The abutments are used in dentistry to connect a dental prosthesis to a dental implant.

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Image /page/13/Picture/0 description: The image shows the logo for DenQ Implant. The logo is pink and features the word "DenQ" in a stylized font. Below the word "DenQ" is the word "IMPLANT" in a smaller, sans-serif font. The logo is simple and modern, and the pink color gives it a friendly and approachable feel.

510(k) Summary K240977

| Multi-<br>unit<br>(St. &<br>Angled) | Image: Multi-unit (St. & Angled) | Image: Multi-unit (St. & Angled) | Product Code | NHA | | NHA | | | |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|---------------------------|-------------------------------------------------------|---------------------------------------------|-----------------|
| FreeMilling | Image: FreeMilling | Image: FreeMilling | | The DenQ Sub Abutment is similar indication for use, Materials, Structure, Connection type, Surface,<br>Sterilization, and product code as the reference device(K153521). But dimension is included reference<br>device(K153521). And the design(shape) and description are similar with reference device(K153521). But it is<br>different characteristics for each abutment as blow; | | | | | |
| Description | This product is a bone level dental implant<br>Abutment(Endosseous Dental Abutment). It is a<br>dental implant to support and maintain dentures by<br>implanting a fixture into jawbones and prosthetic<br>restoration in case of partial or total loss of natural<br>teeth. This product is excellent biocompatibility, it<br>is aesthetically treated by mechanical and physical<br>coating treatment on titanium alloy. This dental<br>implant superstructure can use cement-fixed and<br>screw fixed prostheses. It is mechanically<br>connected to the bone level dental implant fixture. | Healing Abutment is used to make a soft tissue shape<br>before setting up prosthetics and removing cover screw<br>after osteointegration. Angled Abutment is an abutment<br>which has certain angle to easy for adjustment of<br>installation angle of prosthesis. Temporary Abutment is<br>used temporary until final prosthesis is made to maintain<br>esthetic appreciation and chew ability. Multi-Unit<br>Abutment is used for screw retained multiple case. Solid,<br>Cement and FreeMilling Abutment to fabricate a<br>prosthesis of internal single & bridge cement retained<br>type. | | | DenQ Sub Abutment | Reference device | | | |
| Dimension | Healing | Dia.: Ø4.0, Ø4.5, Ø5.0, Ø5.5, Ø6.0, Ø6.5, Ø7.0<br>G/H Length: -<br>Post length: - | Dia.: Ø4.0, Ø4.5, Ø5.0, Ø5.5, Ø6.0, Ø6.5<br>G/H Length: -<br>Post length: - | | 1. Shape(TiN coating applied) | Multi-unit(Angled) | Non-applied | Partial applied | |
| | Solid | Dia.: Ø4.0, Ø4.5, Ø5.0, Ø5.5, Ø6.0, Ø6.5, Ø7.0<br>G/H: 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0mm<br>P/L: 4, 5.5, 7mm | Dia.: Ø4.0, Ø4.5, Ø5.0, Ø5.5, Ø6.0, Ø6.5, Ø7.0<br>G/H: 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0mm<br>P/L: 4, 5.5, 7mm | Technological<br>Characteristics | 2. Dimension(Diameter) | Healing | Ø4.0, Ø4.5, Ø5.0, Ø5.5, Ø6.0,<br>Ø6.5, Ø7.0 | Ø4.0, Ø4.5, Ø5.0, Ø5.5, Ø6.0, Ø6.5 | |
| | | | | | | Cement | Ø4.0, Ø4.5, Ø5.0, Ø5.5, Ø6.0,<br>Ø6.5, Ø7.0 | Ø4.5, Ø5.0, Ø5.5, Ø6.0, Ø6.5 |…