Dentium Ti-Base abutments are intended for use on Dentium endosseous dental implants in the edentulous or partially edentulous maxilla or mandible, as an aid in prosthetic rehabilitation.

All digitally designed abutments for use with Dentium Ti-Base abutments are intended to be sent to a Dentium-validated milling center for manufacture.

Device Description

Dentium Ti-Base is a patient specific abutment fabricated by Dentium and composed of unalloyed titanium and zirconia ceramic. The Ti-Base has a titanium pre-manufactured precision abutment/implant interface and ceramic superstructure bonded to the post of the titanium base. Ti-Base is used for support of CAD/CAM fabricated zirconia superstructures or for support of hybrid crowns or bridges. Hybrid crowns or bridges and zirconia superstructures are manufactured by a Dentium validated milling center.

Ti-Base Abutments are available in two prosthetic diameters (4.5 and 5.5 mm) and four gingival heights (0.5, 1.0, 1.5, and 2.0 mm). Each of the abutments is available indexed and non-indexed. All subject device abutments are compatible with Dentium and Dentium Superline dental implants.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Dentium Ti-Base dental abutment, establishing its substantial equivalence to previously marketed predicate devices. This type of submission relies on non-clinical performance data rather than extensive clinical studies with specific acceptance criteria as might be seen for novel devices.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (What was measured)	Device Performance (Result)
Sterilization Validation	According to ISO 17665-2 to an SAL of 10⁻⁶
Cytotoxicity	According to ISO 10993-5, determining the subject device is non-cytotoxic
Dynamic Compression-Bending Strength	According to ISO 14801, ensuring that the subject device is strong enough for its intended use (Specific values not provided)
Substantial Equivalence (Indications for Use)	Determined to be substantially equivalent to predicate devices (K150367, K161713)
Substantial Equivalence (Design, Function, Material, Manufacture)	Determined to be substantially equivalent to predicate devices, with minor differences in design dimensions and implant/abutment interface noted for K150367 and K161713. Materials are similar (Unalloyed Titanium ASTM F67, Zirconia ISO 13356).
Substantial Equivalence (Physical Dimensions)	Encompasses the same range of physical dimensions (diameter, gingival height, angle of abutments) as predicate devices.

2. Sample Sizes and Data Provenance

Test Set Sample Size: Not explicitly stated for any of the non-clinical tests. For ISO 14801, typical sample sizes are small (e.g., n=5 or n=10 per test condition), but this is not specified.
Data Provenance: The studies are non-clinical (laboratory/mechanical testing). The manufacturer is Dentium Co., Ltd. in the Republic of Korea. Therefore, the data originates from the manufacturer's testing or a contracted testing facility. All data is presumably prospective as it was generated to support the 510(k) submission.

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable as the studies are non-clinical performance tests for a device seeking substantial equivalence, not a diagnostic algorithm requiring expert-established ground truth. The "ground truth" for these tests is defined by the standards (ISO 17665-2, ISO 10993-5, ISO 14801).

4. Adjudication Method for the Test Set

This information is not applicable as the studies are non-clinical performance tests and do not involve human adjudication for a "test set" in the context of diagnostic assessment.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a physical dental abutment, not a diagnostic AI system that would assist human readers.

6. Standalone (Algorithm Only) Performance Study

No, a standalone (algorithm only) performance study was not done. The device is a physical medical device. The "digitally designed abutments" mentioned refer to CAD/CAM processes used in manufacturing, but this is a manufacturing method, not an AI algorithm requiring standalone performance evaluation in the medical sense.

7. Type of Ground Truth Used

The "ground truth" applied here is primarily established international standards for medical device testing (e.g., ISO 17665-2 for sterilization, ISO 10993-5 for cytotoxicity, ISO 14801 for mechanical strength). For substantial equivalence, the performance is compared against the characteristics of legally marketed predicate devices.

8. Sample Size for the Training Set

This information is not applicable. The device is a physical product, not an AI/ML algorithm that is "trained" on a dataset. The manufacturing process might involve CAD/CAM software, but this is distinct from an AI training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no "training set" in the context of an AI/ML algorithm.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 11, 2018

Dentium Co., Ltd. % Linda Schulz Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130

Re: K171622

Trade/Device Name: Dentium Ti-Base Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: December 14, 2017 Received: December 15, 2017

Dear Linda Schulz:

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. 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.

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Mary S. Runner -S

For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K171622

Device Name

Dentium Ti-Base

Indications for Use (Describe)

Dentium Ti-Base abutments are intended for use on Dentium endosseous dental implants in the edentulous or partially edentulous maxilla or mandible, as an aid in prosthetic rehabilitation.

All digitally designed abutments for use with Dentium Ti-Base abutments are intended to be sent to a Dentium-validated milling center for manufacture.

Type of Use (Select one or both, as applicable)
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☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary Dentium Co., Ltd. Dentium Ti-Base

January 11, 2018

ADMINISTRATIVE INFORMATION Manufacturer Name Dentium Co., Ltd. 150, Eondong-ro, Giheung-gu Yongin-si, Gyeonggi-do, 443-270 Republic of Korea Telephone: +82-31-207-2200 Fax: +82-31-207-3883 Official Contact Byungsun Kim, Team Manager of Regulatory Affairs Representative/Consultant Linda K. Schulz, BSDH, RDH Kevin A. Thomas, PhD PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130 Telephone: +1-858-792-1235 Fax: +1-858-792-1236 Email: LSchulz@paxmed.com KThomas@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name	Dentium Ti-Base
Common Name	Abutment, implant, dental, endosseou
Classification Name	Endosseous dental implant abutment
Classification Regulations	21 CFR 872.3630
Product Code	NHA
Classification Panel	Dental Products Panel
Reviewing Branch	Dental Devices Branch

PREDICATE DEVICE INFORMATION

Primary Predicate for Ti-Base K150367, Neodent Implant System, JJGC Indústria e Comércio de Materiais Dentários SA

Reference Predicates K161713, Dentium CAD/CAM Abutments, Dentium Co., Ltd. K041368, Dentium Company Limited Implantium®, Dentium Co., Ltd. K160965, Dentium SuperLine® Implants, Dentium Co., Ltd.

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INDICATIONS FOR USE

Dentium Ti-Base abutments are intended for use on Dentium endosseous dental implants in the edentulous or partially edentulous maxilla or mandible, as an aid in prosthetic rehabilitation.

All digitally designed abutments for use with Dentium Ti-Base abutments are intended to be sent to a Dentium-validated milling center for manufacture.

DEVICE DESCRIPTION

PERFORMANCE DATA

Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: sterilization validation according to ISO 17665-2 to an SAL of 10°, Cytotoxicity testing according to ISO 10993-5 determining the subject device is non-cytotoxic , and dynamic compression-bending testing according to ISO 14801 ensuring that the subject device is strong enough for its intended use. No clinical data were included in this submission.

EQUIVALENCE TO MARKETED DEVICE

The subject device is substantially equivalent in indications and design principles to the predicate devices shown above. Below is a summary table showing technical comparison between the subject device abutments and the predicate device abutments.

	Indications for Use Statement
Subject Device
Dentium Ti-BaseDentium Co., Ltd.	Dentium Ti-Base abutments are intended for use on Dentium endosseous dental implantsin the edentulous or partially edentulous maxilla or mandible, as an aid in prostheticrehabilitation.All digitally designed abutments for use with Dentium Ti-Base Abutments are intended tobe sent to a Dentium-validated milling center for manufacture.
Primary Predicate Device
K150367Neodent Implant SystemJJGC Indústria e Comércio deMateriais Dentários SA	Titanium Base Abutment is a titanium base placed onto Neodent dental implants toprovide support for customized prosthetic restorations. It is used with a coping and crown,or crown alone, and is indicated for cement-retained single or multi-unit restorations, orscrew-retained single restorations.PreFace Abutment is a titanium abutment to be used in fabricating a full custom abutmentand placed onto Neodent dental implants to provide support for customized prostheticrestorations. PreFace Abutments are indicated for screw-retained single restorations orcement-retained single or multi-unit restorations.

Table of Substantial Equivalence - Indications for Use Statement

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Reference Predicate Devices	Indications for Use Statement
K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.	Dentium abutments are intended for use on endosseous dental implants in the edentulousor partially edentulous maxilla or mandible, as an aid in prosthetic rehabilitation.All digitally designed abutments for use with Dentium CAD/CAM Abutments areintended to be sent to a Dentium-validated milling center for manufacture.
K041368Dentium Company LimitedImplantium®Dentium Co., Ltd.	The Dentium Co., Ltd Implantium is intended to be surgically placed in the bone of theupper or lower jaw arches to provide support for prosthetic devices, such as artificialteeth, and to restore the patient's chewing function. This may be accomplished by either atwo-stage surgical procedure or a single surgical procedure. If a single surgical procedureis used, single or multiple implants may be inserted (type I, II or III bone) provided goodinitial stability (> 40 Ncm) is achieved. Not intended for immediate loading.
K160965Dentium SuperLine® ImplantsDentium Co., Ltd.	Superline is indicated for use in surgical and restorative applications for placement in thebone of the upper or lower jaw to provide support for prosthetic devices, such as artificialteeth, in order to restore the patient's chewing function. Superline Implant System isindicated also for immediate loading when good primary stability is achieved and withappropriate occlusal loading.

Comparison	Subject Device	Primary Predicate Device	Reference Predicate Device
	Dentium Ti-BaseDentium Co., Ltd.	K150367Neodent Implant SystemJJGC Indústria e Comércio deMateriais Dentários SA.	K161713Dentium CAD/CAM AbutmentsDentium Co. Ltd.
Design
Abutment Design	CAD/CAM Ti-Base	CAD/CAM BlankCAD/CAM TiBase	CAD/CAM BlankCAD/CAM Custom Abutment
ProsthesisAttachment	Cement-retainedScrew-retained	Cement-retainedScrew-retained	Cement-retainedScrew-retained
Restoration	Single-unit,Multi-unit	Single-unit,Multi-unit	Single-unit,Multi-unit
Abutment/ImplantPlatform Diameter	3.6 - 7.0 mm	3.0 - 6.0 mm	3.6 - 5.0 mm
Abutment Angle	Up to 30°	Up to 30°	Up to 30°
Abutment/ ImplantInterface	Internal	Internal	Internal
Material
Abutment	Unalloyed TitaniumASTM F67	Titanium AlloyASTM F136	Unalloyed TitaniumASTM F67
Superstructure	ZirconiaISO 13356	ZirconiaISO 13356	NA

The subject device Ti-Base is substantially equivalent to the predicate Neodent Titanium Base Abutment cleared in K150367 in design, function, material, manufacture and intended use. Both are titanium abutment for support of direct crowns/bridges or CAD/CAM fabricated zirconia copings manufactured by a validated milling center. Differences between the subject device and predicate device are in the design dimensions and implant/abutment interface.

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All subject device abutments are by prescription order from a clinician, and have the same implant/abutment interface as the predicate K161713. Subject device abutments are compatible with Dentium Implantium (K041368) and Dentium SuperLine (K160965) dental implants.

The Indications for Use of the subject device is substantially equivalent to the previously cleared Intended Use in K150367. The Indications for Use Statement in K150367 includes two abutment designs (TiBase and Preface) and names the individual restoration options. The Indications for Use Statement for the subject device is for one device and does not list the individual restoration options. Minor differences in wording between the Indications for Use Statements do not affect the intended use of a dental abutment placed on a dental implant for prosthetic restoration.

The Indications for Use of the subject device is substantially equivalent as Dentium CAD/CAM Abutments in K161713, with the only difference being in the proprietary name of the device.

CONCLUSION

The subject device and the predicate devices have intended use, have similar technological characteristics, and are made of similar materials. The subject device and predicate devices encompass the same range of physical dimensions, including diameter, gingival height, and angle of the abutments. The subject and predicate devices are packaged in similar materials and are to be sterilized using similar methods.

The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)