Who is the manufacturer of LOTA SLA Dental Implant System and LOTA HA Dental Implant System?

Kj Meditech Co., Ltd. filed the 510(k) submission for LOTA SLA Dental Implant System and LOTA HA Dental Implant System (K202046).

What is the FDA product code for LOTA SLA Dental Implant System and LOTA HA Dental Implant System?

DZE. It is classified under 21 CFR 872.3640 as a Class 2 device in the Dental panel.

What is the regulatory pathway for LOTA SLA Dental Implant System and LOTA HA Dental Implant System?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like LOTA SLA Dental Implant System and LOTA HA Dental Implant System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

LOTA SLA Dental Implant System and LOTA HA Dental Implant System

K202046 · Kj Meditech Co., Ltd. · DZE · Mar 1, 2022 · Dental

Device Facts

Record ID	K202046
Device Name	LOTA SLA Dental Implant System and LOTA HA Dental Implant System
Applicant	Kj Meditech Co., Ltd.
Product Code	DZE · Dental
Decision Date	Mar 1, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3640
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The LOTA SLA Dental Implant System and LOTA HA Dental Implant System are 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. The LOTA SLA Dental Implant System and LOTA HA Dental Implant System are for single and two stage surgical procedures. These systems are intended for delayed loading.

Device Story

Endosseous dental implant system; titanium 6AL 4V ELI alloy (ASTM F136). Implants surgically placed in maxilla or mandible to replace missing teeth; support single/multiple-unit restorations. System includes fixtures and abutments (Shouldered, Shouldered Hex, Shouldered Removal). Used by dental clinicians in clinical settings. Implants feature tapered body design and internal locking taper connection. SLA surface treatment applied to fixtures. Device provides structural foundation for prosthetic restorations; benefits patients by restoring oral function and aesthetics. Sterilized via gamma radiation.

Clinical Evidence

Bench testing only. Evidence includes risk analysis (ISO 14971), sterilization validation (ISO 11137-1/2), shelf-life validation (ASTM F1980-7, ASTM F88, ISO 11607, ISO 11737-2), endotoxin testing (USP 39 <85>, limit 0.5 EU/mL), and Scanning Electron Microscopy (SEM) to confirm absence of surface residuals.

Technological Characteristics

Material: Titanium 6AL 4V ELI (ASTM F136). Design: Bone-level, tapered body, internal locking taper connection. Surface: SLA treatment. Sterilization: Gamma radiation. Dimensions: Diameters 3.8-7.3mm, Lengths 8.0-14.0mm.

Indications for Use

Indicated for partially or fully edentulous patients (adults) requiring single or multiple-unit dental restorations, including cemented, screw-retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. Suitable for single 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

KJ Submerged System (K103810)

Reference Devices

Bicon Implants with a 2.5mm Internal Connection (K092035)
Inclusive® Titanium Abutments compatible with: MegaGen AnyRidge® Implant System (K170044)
J2a Dental Implant System, J2c Dental Implant System (K150060)
J2A SLA Dental Implant System (K161923)

Related Devices

K240966 — Prima Plus Conical Implant System · Keystone Dental, Inc. · Jul 9, 2024
K121585 — TS IMPLANT SYSTEM · Osstem Implant Co., Ltd. · Jan 7, 2013
K253493 — Dentis SQ-SL AXEL Fixture · Dentis Co., Ltd. · Mar 4, 2026
K243078 — HexaPLUS S OneDrill Implant System · Osseofuse International, Inc. · Oct 10, 2025
K223924 — LW Implant System · Ossvis Co., Ltd. · Aug 8, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: 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. KJ Meditech Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 1150 Roosevelt STE 200 Irvine, California 92620 Re: K202046 Trade/Device Name: LOTA SLA Dental Implant System and LOTA HA Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: February 9, 2022 Received: February 18, 2022 Dear Priscilla Chung: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. 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 Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) Device Name LOTA SLA Dental Implant System and LOTA HA Dental Implant System Indications for Use (Describe) The LOTA SLA Dental Implant System and LOTA HA Dental Implant System are 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. The LOTA SLA Dental Implant System and LOTA HA Dental Implant System are for single and two stage surgical procedures. These systems are intended for delayed loading. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------| | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510(k) Summary (K202046) This summary of 510(K) information is being submitted in accordance with requirements of 21 CFR Part 807.92. Date: 2/28/2022 ## 1. Submitter KJ Meditech Co., Ltd. 959-21 Daechon-dong, Buk-gu, Gwang-ju, Republic of Korea Tel: +82-62-972 -5476 Contract Person: Hyuckki Moon / President ## 2. U.S Agent/Contact Person Priscilla Chung LK Consulting Group USA, Inc. 1150 Roosevelt STE 200, Irvine CA 92620 Phone: 714.202.5789 Fax: 714-409-3357 Email: juhee.c(@lkconsultinggroup.com ## 3. Device - Trade Name: LOTA SLA Dental Implant System ● LOTA HA Dental Implant System - Common Name: Dental implant system - Classification Name: Endosseous dental implant ● - . Product Code: DZE, NHA - Classification regulation: 21 CFR 872.3640 ## 4. Predicate Device - Primary Predicate: ● - KJ Submerged System by KJ Meditech Co., Ltd. (K103810) - - . Reference Devices: {4}------------------------------------------------ - -Bicon Implants with a 2.5mm Internal Connection by BICON, LLC (K092035) - -Inclusive® Titanium Abutments compatible with: MegaGen AnyRidge® Implant System by Megagen Implant Co., Ltd. (K170044) - J2a Dental Implant System, J2c Dental Implant System by KJ Meditech Co., Ltd. -(K150060) - J2A SLA Dental Implant System by KJ Meditech Co., Ltd. (K161923) - # 5. Device Description The LOTA SLA Dental Implant system and LOTA HA Dental Implant System are dental implant systems made of Titanium 6AL 4V ELI alloy, which confirms to ASTM F136, intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implants may be used to replace one or more missing teeth. All diameters are available with all lengths. | Implant Diameter | 3.8mm, 4.3mm, 4.8mm, 5.3mm, 6.3mm, 7.3mm | |------------------|------------------------------------------------------| | Implant Length | 8.0mm, 9.0mm, 10.0mm, 11.0mm, 12.0mm, 13.0mm, 14.0mm | The implants are used with the following abutments. The Shouldered Abutments and the Shouldered Hex Abutments have internal connection structure, and they adopt locking taper connection. They restore fixed crown and bridge restorations. The Shouldered Removal Abutment uses screw and locking taper connection to be connected with the fixture. It has the same intended use as the other abutments. All the abutments are not intended for angulation. - I Shouldered Abutment - 트 Shouldered Hex Abutment - 트 Shouldered Removal Abutment The systems are similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. ## 6. Indication for Use The LOTA SLA Dental Implant System and LOTA HA Dental Implant System are 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. The LOTA SLA Dental Implant System and LOTA HA Dental Implant System are for single and two stage surgical procedures. These systems are intended for delayed loading. {5}------------------------------------------------ ## 7. Basis for Substantial Equivalence The subject device and the predicate device (KJ Submerged System, K103810) have the same indications and fundamental scientific technology. The subject and predicate devices employ the same materials and have very similar in design. The fixture thread design, the fixture size, and abutment design have changed, and we have identified a reference device which are similar in design and size. The Bicon Implants (K092035) has similar thread design, and the J2a Dental Implant System, J2c Dental Implant System have similar neck micro-threading design. We identified MegaGen AnyRidge® Implant System (K170044) as a reference device which encompasses the size range of the subject device. Another difference is that the subject fixtures have SLA treatment. This difference poses potential risks in biocompatibility, sterilization/shelf-life validation, and residual remining on the fixtures. To mitigate these risks, we identified a predicate device made by our company(K161923) which go through the same manufacturing processes and have the same material/surface treatment. Also, we performed sterilization/shelf-life validation tests, and SEM analysis to validate that the modification would not raise an issue to support substantial equivalence. | Item | Subject Device | Predicate Device | Reference Device | Reference Device | Reference Device | Reference Device | |-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(K) Number | K202046 | K103810 | K092035 | K170044 | K150060 | K161923 | | Device Name | LOTA SLA/ HA Dental Implant | KJ Submerged System | Bicon Implants with a 2.5mm Internal Connection | Inclusive® Titanium Abutments compatible with: MegaGen AnyRidge® Implant System | J2a Dental Implant System, J2c Dental Implant System | J2A SLA Dental Implant | | Manufacturer | KJ Meditech Co., Ltd. | KJ Meditech Co., Ltd. | BICON, LLC | Megagen Implant Co.,Ltd. | KJ Meditech Co., Ltd. | KJ Meditech Co., Ltd. | | Indications for Use | The LOTA SLADental 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. | The KJ Submerged System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple- unit restorations including; cemented | The Bicon implant is designed for use in edentulous sites in the mandible or maxilla for support of a complete denture prosthesis, a final or intermediate abutment for fixed bridgework or for partial | Inclusive® Titanium Abutments are premanufactured prosthetic components connected to endosseous dental implants in the edentulous or partially edentulous maxilla or mandible to provide support for cement- retained or | The J2C Dental 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. | The J2A SLA Dental 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 | | | screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The LOTA SLA Dental Implant is for single and two stage surgical procedures. The system is intended for delayed loading. | retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The KJ Submerged System is for single and two stage surgical procedures. The system is intended for delayed loading. | dentures, or as a single tooth replacement. | screw-retained prosthetic restorations. | screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The J2C Dental Implant System is for single and two stage surgical procedures. The system is intended for delayed loading. | intermediate abutment support for fixed bridgework. The J2A SLA Dental Implant is for single and two stage surgical procedures. The system is intended for delayed loading. | | Design | • Implant Type: Bone Level Implant • Connection Type: Internal Locking Taper • Neck Design: Straight walled neck • Body Design: Tapered design | • Implant Type: Bone Level Implant • Connection : Internal Locking Taper • Neck Design: Straight walled neck • Body Design: Tapered design | • Implant Type: Bone Level Implant • Connection: Internal Locking Taper • Neck Design: Straight walled neck • Body Design: Tapered design | All digitally designed abutments for use with Inclusive Abutments for CAD/CAM are intended to be sent to a Prismatik Dental craft validated milling center for manufacture. Compatible Implant System: MegaGen AnyRidge® Implant System Inclusive Titanium Abutments compatible with MegaGen AnyRidge Implant System | • Implant Type: Bone Level Implant • Connection Type: Internal Hexagon • Neck Design: Straight walled neck with micro- thread • Body Design: Tapered design | • Implant Type: Bone Level Implant • Connection Type: Internal Hexagon • Neck Design: Straight walled neck • Body Design: Tapered design | | Endosseous Implant Material | Ti 6Al 4V ELI, ASTM F136 | Ti 6Al 4V ELI, ASTM F136 | Ti 6Al 4V ELI, ASTM F136 | Ti 6Al 4V ELI, ASTM F136 | Ti 6Al 4V ELI, ASTM F136 | Ti 6Al 4V ELI, ASTM F136 | | Surface Treatment | SLA Treatment | RBM Treatment HA Coating | HA Coating | S-L-A with Nano Ca2+ incorporated | RBM Treatment | SLA Treatment | #### LOTA SLA/HA Fixture 510(k) summary 3 / 6 page {6}------------------------------------------------ {7}------------------------------------------------ | Sterilization Method | Gamma | Gamma | Gamma | Gamma | Gamma | Gamma | |-------------------------|------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|----------------------------------------|----------------------------------------------------------------------------------------|--------------------------------------------------------------------------|------------------------------------------------------------| | Implant Diameters | 3.8mm, 4.3mm, 4.8mm, 5.3mm, 6.3mm, 7.3mm | 3.5mm, 4.0mm, 4.5mm, 5.0mm, 5.5mm, 6.0 mm | 4.0 mm, 4.5mm | 3.5mm, 4.0mm, 4.4mm, 4.9mm 5.4mm, 5.9mm 6.4mm, 6.9mm 7.4mm, 7.9mm 8.4mm | 3.75mm, 4.00mm, 4.30mm, 4.50mm, 5.00mm, 5.50mm, 6.00mm | 3.75mm, 4.0mm, 4.3mm, 4.5mm, 5.0 mm, 5.5mm, 6.0mm | | Implant Lengths | 8.0mm, 9.0mm, 10.0mm, 11.0mm, 12.0mm, 13.0mm, 14.0mm | 8.10mm, 8.30mm, 8.64mm, 8.91mm, 9.00mm, 9.69mm, 10.0mm, 11.0mm, 12.0mm, 14.0mm | 5.0mm, 6.0 mm, 8.0 mm, 11.0mm | 7.0mm, 8.5mm 10.0mm, 11.5mm 13.0mm, 15.0mm | 7mm, 8.5mm, 10.0mm, 11.5mm, 13.0mm, 15mm | 7mm – 15.0 mm | | Cover Screw | N/A | N/A | N/A | N/A | Ti 6Al 4V ELI, ASTM F136 | Ti 6Al 4V ELI, ASTM F136 | ### LOTA Abutment LOTA Shouldered Abutments | Item | Subject Device | Predicate Device | |-----------------------|-------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------| | 510(K) Number | K202046 | K103810 | | Device Name | LOTA SLA Dental Implant | KJ Submerged System | | Manufacturer | KJ Meditech Co., Ltd. | KJ Meditech Co., Ltd. | | One Piece Abutment | ■ Ti 6Al 4V ELI, ASTM F136 ■ Well : Ø2.0~ Ø3.0 ■ Diameter: Ø4.0mm ~ Ø6.5mm ■ Height:6.85mm~11.35mm Post Length: 2mm~4mm | ■ Ti6Al4V ELI, ASTM F136 ■ Well: Ø 2.0~ Ø 3.0 ■ Diameter: Ø3.5mm~ Ø6.0mm ■ Height:10.7mm~15mm ■ Post Length: 4mm~6mm | ### LOTA Shouldered Removal Abutments | Item | Subject Device | Predicate Device | |------------------|-------------------------|-------------------------------| | 510(K) Number | K202046 | K161923 | | Device Name | LOTA SLA Dental Implant | J2A SLA Dental Implant System | | Manufacturer | KJ Meditech Co., Ltd. | KJ Meditech Co., Ltd. | {8}------------------------------------------------ | Two Piece Abutment | • Ti 6Al 4V ELI, ASTM F136 • Well: Ø2.5~Ø3.0 • Diameter: Ø5.0mm ~ Ø6.5mm • Height: 6.85mm~11.35mm • Post Length: 2mm~4mm | • Ti 6Al 4V ELI, ASTM F136 • TiN Coating • Well: Ø2.78~Ø3.33 • Diameter: Ø4~Ø7 • Cuff: 1mm~5mm • Height: 4.0mm~7.0mm | |-----------------------|--------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------| |-----------------------|--------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------| ## 8. Non-Clinical Testing Risk analysis was conducted according to ISO14971 to evaluate the effect of the modification and based on the analysis, the following activities/tests were performed. - " Identifying reference devices for the modifications in fixture thread design, the fixture size, and abutment design to make sure the subject device is not introducing new design or size range which will raise a concern. - For the modification in surface treatment, identifying a predicate device which is made by our company having the same material/surface treatment and going through the same manufacturing processes. - . Sterilization validation test in accordance with ISO 11137-1 and 11137-2, and shelf life validation tests in accordance with ASTM F1980-7, ASTM F88, ISO 11607, and ISO 11737-2. - Endotoxin testing for lot release was evaluated in accordance with USP 39 <85> the endotoxin limit which is 0.5 EU/mL. - Scanning Electron Microscopy (SEM) to validate there is no residual remaining on the implants. ## 9. Conclusion Based on the similarities and the test results of the validation activities, we conclude that the LOTA SLA Dental Implant System and LOTA HA Dental Implant System are substantially equivalent to the predicate device.