Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a traditional dental implant system made of titanium, with no mention of AI, ML, image processing, or any software-driven features that would suggest the use of these technologies. The performance studies focus on material properties and mechanical testing.

Therapeutic

Yes
The device is a dental implant system surgically placed in bone to support restorations, directly addressing a health condition (edentulism) by restoring function and aesthetics.

Diagnostic

No.

The device is a dental implant system used for supporting dental restorations and is surgically placed, not used for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a dental implant made of titanium metal and includes various physical components like abutments. The performance studies focus on material properties and mechanical testing, not software validation.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device is for surgical placement in the bone of the jaw to support dental restorations. This is a surgical and prosthetic application, not a diagnostic test performed in vitro (outside the body) on biological samples.
Device Description: The description details a dental implant made of titanium and associated abutments. This aligns with a surgically implanted medical device, not a diagnostic reagent or instrument used for analyzing samples.
No Mention of Diagnostic Testing: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
Performance Studies: The performance studies focus on the physical and mechanical properties of the implant (sterilization, shelf-life, biocompatibility, fatigue, shear, tension, surface analysis), which are relevant to a surgically implanted device, not an IVD.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications 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.

Product codes

DZE, NHA

Device 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
| Product name | Division | Platform Diameters (Fixture Diameter) | Body Diameters | Lengths |
|---|---|---|---|---|
| Fixture I | Regular | Ø3.75, Ø3.77 | - | 7, 7.5, 8, 8.5, 9, 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, 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, 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 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Mandibles and maxillae

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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)

Summary of non-clinical test data:
The following tests, verification and validations were performed in accordance with ISO standards and US regulations.

Gamma Sterilization Validation test according to ISO 11137-1, -2
Shelf-life Validation test according to ISO 11607-1, ISO 11607-2, ASTM F1980-16, ASTM F1140-13, ASTM A F2096-11 and ASTM F88/F88M-15
BET Validation test according to USP A
User Sterilization Validation test according to ISO 17665-1, -2 A
Biocompatibility test according to ISO 10993-1 and ISO 14971 A
A Fatigue test according to ISO 14801
A Shear testing was performed per ASTM F1044
A Tension testing was performed per ASTM F1147
Abrasion characteristics was determined by a scratch test drawn across the coated surface under an increasing load (either stepwise or continuous) until at some load (termed as critical load) a well-defined failure event occurs. Information clearly indicating the test protocol, selection of the load range used for the scratch test, type of indenter used to perform the scratch of the surface, depth of the scratch with respect to the applied load, failure event selection criteria, and high mages clearly demonstrating the coating detachment was provided.
A Surface analysis according to the FDA guidance document including SEM/EDS analysis.

The fatigue test for DenQ Sub straight type Abutment and DenQ Sub Angled Abutment and DenQ Sub SLA Fixture were conducted according to the "Guidance for industry and FDA staff Class II Special Controls Got-form Endosseous Dental Implants and Endosseous Dental Abutment" and ISO 14801:2016 Dentistry-Implant-Dynamic loading test for endosseous dental implant. This was tested based on the wore compliant and similar to previously cleared primary predicate devices. Those tests have been performed to evaluate the surface characteristics compared to the primary predicate device. The results of the above tests have met the standards and demonstrated the substantial equivalence with the primary predicate device. The non-clinical testing demonstrate that the subject device is substantially equivalent to the primary predicate device.

MR Environment: MR Conditional
Non-clinical worst-case MRI review was performed to evaluate the metallic DenQ Sub SLA Implant System devices in the MRI environment using scientific rationale and published literature (i.e., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Nagnetically Induced Displacement Force and Torque on Metal Devices." Journal of Testing and Evaluation 49, no.2 (March/April 2021): 783-795), based on the entire system to include all variations (all compatible implant bodies, dental and fixation screws) and material compositions. The rationale addressed parameters per the FDA Guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment", including magnetically induced displacement force and torque."

Summary of clinical testing:
No clinical testing was performed for this submission.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K222707

Reference Device(s)

K121995, K213576, K230108, K153521

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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.

1

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.

2

3

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.

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

3

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: +82-51-514-4888 Email: ceo@deng.kr

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
name | Division | Platform Diameters
(Fixture Diameter) | Body Diameters | Lengths |
|-----------------|----------|------------------------------------------|----------------|--------------------------------------|
| Fixture I | Regular | Ø3.75, Ø3.77 | - | 7, 7.5, 8, 8.5, 9,
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,
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,
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
device | Reference device | | |
|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | DenQ Sub SLA
Implant System | IH Implant System | TS Fixture System | Tatum Surgical
Dental Implant
System | Straumann® BLC and
TLC Implants |
| 510(k)
Number | K240977 | K222707 | K121995 | K213576 | K230108 |
| Manufacturer | DenQ Co., Ltd. | Sewon Medix Inc. | Osstem Implant Co.,
Ltd. | Suncoast Dental, Inc.
dba Tatum Surgical | Straumann USA, LLC |
| Reason for
primary and
Reference
device | N/A | Major technological
characteristics | Implant body shape,
wide diameter(Ø6.2,
6.8) and
length(712.5mm) | Implant wide
diameter(Ø6.0, 7.0)
and length(1315mm) | Basic surface
treatment, implant
body diameter and
length |
| 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; | IH Implant System is
device made of
titanium and titanium
alloy indicated for in
partially or fully
edentulous mandibles
and maxillae, in
support of single or
multiple-unit | The TS Fixture
System is indicated for
use in partially or full
edentulous mandibles
and maxillae, in
support of single or
multiple-unit
restorations including;
cemented retained. | The Tatum Surgical
Integrity Tapered, "T"
and “S” Dental
Implant Systems are
intended to be
surgically placed in
the bone of the upper
or lower jaw to
provide support for | Straumann® dental
implants are indicated
for the functional and
esthetic oral
rehabilitation of the
upper or lower jaw of
edentulous or partially
edentulous patients.
They can be used for |
| | cemented retained, or
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. | restorations including;
cemented retained or
screw retained
restorations and
terminal or interminal
abutment support for
fixed bridgework. IH
Implant System is for
single and two stage
surgical procedures. It
is intended for delayed
loading. | screw retained, or
overdenture
restorations; and final
or temporary abutment
support for fixed
bridgework. It is
intended for delayed
loading. | removable or fixed
prosthesis to restore
chewing function. It
may be used with
single-stage or two-
stage procedures, for
single or multiple unit
restorations, and may
be loaded immediately
when good primary
stability is achieved
and with appropriate
occlusal loading. | immediate, early or
late implantation
following the
extraction or loss of
natural teeth. The
implants can be placed
with immediate
function for single-
tooth and/or multiple-
tooth restorations
when good primary
stability is achieved
and with appropriate
occlusal loading to
restore chewing
function. |
| Material | CP Titanium Gr.4
(ASTM F67-13) | CP Titanium Gr.4
(ASTM F67-13) | CP Titanium Gr.4
(ASTM F67-13) | Ti 6Al 4V
(ASTM F136-13) | Titanium-13
Zirconium alloy
(Roxolid®) |
| Design
(Fixture
Type) | Image: Fixture I | Image: Mini | Image: TSII SA Fixture | Image: Ti 6Al 4V | Image: Titanium-13 Zirconium alloy |
| Fixture
Diameter | Fixture I
Reg.: Ø3.75, Ø3.77,
Ø4.25, Ø4.6, Ø4.63 | Mini: Ø3.7
Reg.: Ø3.8, Ø4.2,
Ø4.5, Ø5.0, Ø5.95 | TSII SA Fixture
Ø3.5, Ø4.2, Ø4.4,
Ø4.9
TSIII SA Fixture | Ø3.7, 4.0, Ø4.5, Ø5.0,
Ø6.0, Ø7.0, Ø8.0 | Ø3.3, Ø3.75, Ø4.5,
Ø5.5, Ø6.5 |
| | Ø4.65, Ø5.05, Ø5.08,
Ø5.1
Wide: Ø5.95, Ø 6.8
Fixture II
Reg.: Ø4.21, Ø4.67,
Ø5.14
Wide: Ø6.2, Ø6.8
Fixture III
Reg.: Ø4.25, Ø4.6,
Ø4.63, Ø4.65, Ø5.05,
Ø5.08, Ø5.1
Wide: Ø5.95, Ø 6.8 | | Ø3.75, Ø3.77, Ø4.2,
Ø4.25, Ø4.6, Ø4.63,
Ø4.65, Ø5.05, Ø5.08,
Ø5.1
TSIII SA Ultra-Wide
Fixture
Ø5.92, Ø5.95, Ø6,
Ø6.8 | | |
| Fixture
Length | Fixture I
715mm
Fixture II, III
714 mm | 7.0, 8.5, 10, 11.5, 13,
15 mm | TS Fixture
715 mm
TS III SA Ultra-Wide
Fixture
712.5 mm | 9, 11, 14, 17, 20 mm
(no 20 mm length for
Ø7 and 8 mm) | BLC: Ø3.3: 818mm
Ø3.75 and Ø4.5:
618mm
Ø5.5: 616mm
Ø6.5: 614mm
TLC: Ø3.3, Ø3.75
and Ø4.5 of BLC are
same
Ø5.5: 612mm
Ø6.5: 610mm |
| Structure | - Internal Hex-
connected
-Bone level

Tapered & straight
body shape
Cutting edge with
self-tapping
0.8mm thread pitch | - Internal Hex-
connected
-Bone level
Tapered body shape
Cutting edge with
self-tapping
0.8mm thread pitch | - Internal Hex-
connected
-Bone level
Tapered body shape
and straight body
shape
4 sided cutting edge
with self-tapping | - Tissue or Bone
Level
Threaded
Tapered body
Root-form implant | Apically tapered
Bone Level
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
type | Internal hex
connection | Internal hex
connection | Internal hex
connection | Internal Pentagon
connection | TorcFit(with conical
fitting) | |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|----------------------------|------------------------------------------|--------------------------------------|--|
| Surgery type | One or two stage | One or two stage | One or two stage | One or two stage | One or two stage | |
| Surface
Treatment | SLA | SLA | SA(SLA) | Aluminum oxide
blasted and passivated | Hydrophilic
SLActive® and
SLA® | |
| Gamma
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,
the indication for use of reference devices K121995, K213576 and K230108 are the similar to the Subject device. The
DenQ Sub SLA Implant System has taper body of fixture I, III and taper-straight-taper body shape of fixture II. The
DenQ Sub SLA Implant System has the similar raw material, surface treatment, surgical type, sterilization method, shelf-
life, connection structure, implant basic components and product code as primary predicate device K222707. The
difference between the Subject device and primary predicate device are their similar implant body shape, implant
diameter, and length. The implant shape and configuration were similar to the primary predicate device and reference
device, with bone level, tapered and straight body, cutting edge, and self-tapping structures. The Subject device has
tapered body and tapered-straight-tapered body shapes, but the primary device K222707 has only tapered body shape.
However, the reference device K121995 has an implant body shape with tapered and straight body shapes, and the body
shape of subject device and reference device K121995 are very similar. The implant diameter of subject device ranges
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
similar range to the diameter of primary predicate device. However, implant diameters of Ø6.2 and Ø6.8 are not included
in the primary predicate device. The implant diameters Ø6.2 and Ø6.8 are similar to the reference device K122995 wide
implant Ø6.0 and Ø6.2 of implant diameter of subject device, and the subject device Ø6.8 diameter is similar to Ø6.8
diameter of reference device K122995. The implant length of the Subject device is 715mm, and the implant length of
the primary predicate device is 715mm, but Ø5.95 is 713mm and there is no 15mm. The implant lengths of Subject
device Ø6.2 and Ø6.8x715mm 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
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.	IH Implant System is device made of titanium and
titanium alloy indicated for in partially or fully
edentulous mandibles and maxillae, in support of single
or multiple-unit restorations including ; cemented
retained or screw retained restorations and terminal or
interminal abutment support for fixed bridgework. IH
Implant System is for single and two stage surgical
procedures. It is intended for delayed loading.
Material	Ti 6Al 4V ELI
(ASTM F136-13)
Healing, Solid, Cement, Multi-unit
CP Titanium Gr4
(ASTM F67-13)
Angled, Temporary, FreeMilling	Ti 6Al 4V ELI
(ASTM F136)
Healing, Solid, Cement, Multi-unit
CP Titanium Gr4
(ASTM F67-13)
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-
unit
(St. &

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,
Sterilization, and product code as the reference device(K153521). But dimension is included reference
device(K153521). And the design(shape) and description are similar with reference device(K153521). But it is
different characteristics for each abutment as blow;
Description	This product is a bone level dental implant
Abutment(Endosseous Dental Abutment). It is a
dental implant to support and maintain dentures by
implanting a fixture into jawbones and prosthetic
restoration in case of partial or total loss of natural
teeth. This product is excellent biocompatibility, it
is aesthetically treated by mechanical and physical
coating treatment on titanium alloy. This dental
implant superstructure can use cement-fixed and
screw fixed prostheses. It is mechanically
connected to the bone level dental implant fixture.	Healing Abutment is used to make a soft tissue shape
before setting up prosthetics and removing cover screw
after osteointegration. Angled Abutment is an abutment
which has certain angle to easy for adjustment of
installation angle of prosthesis. Temporary Abutment is
used temporary until final prosthesis is made to maintain
esthetic appreciation and chew ability. Multi-Unit
Abutment is used for screw retained multiple case. Solid,
Cement and FreeMilling Abutment to fabricate a
prosthesis of internal single & bridge cement retained
type.			DenQ Sub Abutment	Reference device
Dimension	Healing	Dia.: Ø4.0, Ø4.5, Ø5.0, Ø5.5, Ø6.0, Ø6.5, Ø7.0
G/H Length: -
Post length: -	Dia.: Ø4.0, Ø4.5, Ø5.0, Ø5.5, Ø6.0, Ø6.5
G/H Length: -
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
G/H: 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0mm
P/L: 4, 5.5, 7mm	Dia.: Ø4.0, Ø4.5, Ø5.0, Ø5.5, Ø6.0, Ø6.5, Ø7.0
G/H: 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0mm
P/L: 4, 5.5, 7mm	Technological
Characteristics	2. Dimension(Diameter)	Healing	Ø4.0, Ø4.5, Ø5.0, Ø5.5, Ø6.0,
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,
Ø6.5, Ø7.0	Ø4.5, Ø5.0, Ø5.5, Ø6.0, Ø6.5
	Cement	Dia.: Ø4.0, Ø4.5, Ø5.0, Ø5.5, Ø6.0, Ø6.5, Ø7.0
G/H: 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0mm
P/L: 4, 5.5, 7mm	Dia.: Ø4.5, Ø5.0, Ø5.5, Ø6.0, Ø6.5
G/H: 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0mm
P/L: 4, 5.5, 7mm			Temporary	Ø4.0, Ø4.5, Ø5.0, Ø5.5, Ø6.0	Ø4.0, Ø4.5
	Angled	Dia.: Ø4.0, Ø4.5, Ø5.0, Ø5.5, Ø6.0
G/H: 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0mm
P/L: 8mm
Angle: 15°, 17°, 20°, 25°	Dia.: Ø4.5, Ø5.0, Ø5.5, Ø6.0
G/H: 2.0, 3.0, 4.0mm
P/L: 7.5, 8mm
Angle: 15°, 25°			Multi-unit Straight	Ø4.8, Ø5.0, Ø5.5	Ø4.8
	Tempor
ary	Dia.: Ø4.0, Ø4.5, Ø5.0, Ø5.5, Ø6.0
G/H: 0.5, 1.0, 1.5, 2.0, 2.5, 3.0mm
P/L: -	Dia.: Ø4.0, Ø4.5
G/H: 1.0, 3.0mm
P/L: -			Multi-unit Angled	Ø4.71, Ø4.92, Ø5.04, Ø5.4, Ø5.5	Ø4.7, Ø5.13
	Multi-
unit
(St.)	Dia.: Ø4.8, Ø5.0, Ø5.5
G/H: 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0mm
P/L: 2.2mm	Dia.: Ø4.8
G/H: 1.5, 2.5, 3.5, 4.5mm
P/L: 2.2mm			FreeMilling	Ø4.5, Ø5.0, Ø5.5, Ø6.0	Ø4.5, Ø5.0, Ø5.5, Ø6.0, Ø6.5
	Multi-
unit
(Angled
)	Dia.: Ø4.71, Ø4.92, Ø5.04, Ø5.4, Ø5.5
G/H: 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5mm
P/L: -
Angled: 15°, 17°, 20°, 25°, 30°	Dia.: Ø4.7, Ø5.13
G/H: 2.5, 3.5, 4.5mm
P/L: -
Angled: 17°, 30°		3. Dimension(G/H Length)
	FreeMil
ling	Dia.: Ø4.5, Ø5.0, Ø5.5, Ø6.0
G/L: 1.0, 2.0, 3.0, 4.0, 5.0mm
H: 8, 9, 10, 11, 12mm	Dia.: Ø4.5, Ø5.0, Ø5.5, Ø6.0, Ø6.5
G/H: 1.0, 2.0, 3.0mm
P/L: 10, 11, 12mm			Multi-unit Straight	0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0,
4.5, 5.0mm	1.5, 2.5, 3.5, 4.5mm
	Structure		Internal Hex				Multi-unit Angled	1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0,
4.5mm	2.5, 3.5, 4.5mm
	Connection type		Screw & Internal Hex-Connected				Temporary	0.5, 1.0, 1.5, 2.0, 2.5, 3.0mm	1.0, 3.0mm
	Surface		Machined or TiN			4. Dimension(Post Length)
	Sterilization		Non-Sterile				Angle	8mm	7.5, 8mm

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Image /page/14/Picture/0 description: The image contains a 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. To the right of the word "DenQ" is a circular design with a dot in the upper right corner.

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Image /page/15/Picture/0 description: The image contains the logo for "DenQ Implant". The logo is pink and features the brand name in a stylized font. Below the brand name, the word "IMPLANT" is written in smaller, uppercase letters.

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Temporary	8, 9, 10, 11, 12mm	10, 11, 12mm
5. Dimension(Angle)
	DenQ Sub Abutment	Reference device
Angled	15°, 17°, 20°, 25°	15°, 25°
Multi-unit(Angled)	15°, 17°, 20°, 25°, 30°	17°, 30°

Substantial Equivalence Discussion

The DenQ Sub SLA Fixture has similar indication for use, material, surgery type, sterilization method, connection type, shelf life, product code and similar design, structure, diameter and technological characteristic as the primary predicate device(K222707). The wide implant diameter and length of subject device differ from the primary predicate device K 122995 and K 213576 support substance of subject device's wide implant diameters and lengths. The basic surface treatment of reference device K230108 supports substantial equivalence to subject device's surface treatment.

The DenQ Sub Abutment is similar indication for use, materials, structure, surface, sterilization, and product code as the device but, the technological characteristic is coating area and dimensions between subject device and the angle is included in the range of the reference device. The coating area, dimension, and angle of abutment of reference device K153521 support substantial equivalence of coating area, dimension, and angle of abutment of subject device.

The DenQ Sub SLA System has been subjected to performance and product validations prior to release. Testing including biocompatibility has been performed to ensure the devices comply with the applicable International and US regulations.

The differences between the subject devices are detailed shape and detailed dimension of diameter, length, angle, gingiva height, post height and coating area.

Summary of non-clinical test data

The following tests, verification and validations were performed in accordance with ISO standards and US regulations.

Gamma Sterilization Validation test according to ISO 11137-1, -2
Shelf-life Validation test according to ISO 11607-1, ISO 11607-2, ASTM F1980-16, ASTM F1140-13, ASTM A F2096-11 and ASTM F88/F88M-15

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Image /page/17/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, uppercase letters. The logo is simple and modern, and the pink color gives it a friendly and approachable feel.

BET Validation test according to USP A
User Sterilization Validation test according to ISO 17665-1, -2 A
Biocompatibility test according to ISO 10993-1 and ISO 14971 A
A Fatigue test according to ISO 14801
A Shear testing was performed per ASTM F1044
A Tension testing was performed per ASTM F1147
Abrasion characteristics was determined by a scratch test drawn across the coated surface under an increasing load (either stepwise or continuous) until at some load (termed as critical load) a well-defined failure event occurs. Information clearly indicating the test protocol, selection of the load range used for the scratch test, type of indenter used to perform the scratch of the surface, depth of the scratch with respect to the applied load, failure event selection criteria, and high mages clearly demonstrating the coating detachment was provided.
A Surface analysis according to the FDA guidance document including SEM/EDS analysis.

The fatigue test for DenQ Sub straight type Abutment and DenQ Sub Angled Abutment and DenQ Sub SLA Fixture were conducted according to the "Guidance for industry and FDA staff Class II Special Controls Got-form Endosseous Dental Implants and Endosseous Dental Abutment" and ISO 14801:2016 Dentistry-Implant-Dynamic loading test for endosseous dental implant. This was tested based on the wore compliant and similar to previously cleared primary predicate devices. Those tests have been performed to evaluate the surface characteristics compared to the primary predicate device. The results of the above tests have met the standards and demonstrated the substantial equivalence with the primary predicate device. The non-clinical testing demonstrate that the subject device is substantially equivalent to the primary predicate device.

MR Environment: MR Conditional

Non-clinical worst-case MRI review was performed to evaluate the metallic DenQ Sub SLA Implant System devices in the MRI environment using scientific rationale and published literature (i.e., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Nagnetically Induced Displacement Force and Torque on Metal Devices." Journal of Testing and Evaluation 49, no.2 (March/April 2021): 783-795), based on the entire system to include all variations (all compatible implant bodies, dental and fixation screws)

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510(k) Summary K240977

and material compositions. The rationale addressed parameters per the FDA Guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment", including magnetically induced displacement force and torque."

Summary of clinical testing

No clinical testing was performed for this submission.

Conclusion

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification DenQ concludes that the Den 2 Substantially equivalent to the primary predicate devices as described herein.