(223 days)
No
The summary does not mention any AI or ML technology, focusing on the physical characteristics and manufacturing process of the dental abutment.
No.
The device is an abutment for dental implants, aiding in prosthetic rehabilitation rather than directly treating a disease or condition.
No
The device is an abutment for dental implants, intended for prosthetic rehabilitation. It supports CAD/CAM fabricated superstructures, rather than diagnosing a condition.
No
The device description clearly states it is a physical abutment made of titanium and zirconia, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the Dentium Ti-Base abutments are physical components (titanium and zirconia ceramic) intended for use on dental implants within the mouth (maxilla or mandible). They are used for prosthetic rehabilitation, meaning they support artificial teeth.
- Intended Use: The intended use is to aid in prosthetic rehabilitation by being placed on dental implants. This is a surgical/restorative procedure, not a diagnostic test performed on a sample.
The information provided describes a medical device used in dentistry for structural support, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NHA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
edentulous or partially edentulous maxilla or mandible
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinician, Dentium-validated milling center
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.)
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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);
1
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) |
|---|
| ------------------------------------------------- |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------- |
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3
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
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.
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-Base | |
| Dentium Co., Ltd. | 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. | |
| Primary Predicate Device | |
| K150367 | |
| Neodent Implant System | |
| JJGC Indústria e Comércio de | |
| Materiais Dentários SA | Titanium Base Abutment is a titanium base placed onto Neodent dental implants to |
| provide 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, or | |
| screw-retained single restorations. | |
| PreFace Abutment is a titanium abutment to be used in fabricating a full custom abutment | |
| and placed onto Neodent dental implants to provide support for customized prosthetic | |
| restorations. PreFace Abutments are indicated for screw-retained single restorations or | |
| cement-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 |
|---|---|
| K161713 | |
| Dentium CAD/CAM Abutments | |
| Dentium Co., Ltd. | Dentium abutments are intended for use on 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 CAD/CAM Abutments are | |
| intended to be sent to a Dentium-validated milling center for manufacture. | |
| K041368 | |
| Dentium Company Limited | |
| Implantium® | |
| Dentium Co., Ltd. | The Dentium Co., Ltd Implantium 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, and to restore the patient's chewing function. This may be accomplished by either a | |
| two-stage surgical procedure or a single surgical procedure. If a single surgical procedure | |
| is used, single or multiple implants may be inserted (type I, II or III bone) provided good | |
| initial stability (> 40 Ncm) is achieved. Not intended for immediate loading. | |
| K160965 | |
| Dentium SuperLine® Implants | |
| Dentium Co., Ltd. | Superline is indicated for use in surgical and restorative applications for placement in the |
| bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial | |
| teeth, in order to restore the patient's chewing function. Superline Implant System is | |
| indicated also for immediate loading when good primary stability is achieved and with | |
| appropriate occlusal loading. |
| Comparison | Subject Device | Primary Predicate Device | Reference Predicate Device |
|---|---|---|---|
| Dentium Ti-Base | |||
| Dentium Co., Ltd. | K150367 | ||
| Neodent Implant System | |||
| JJGC Indústria e Comércio de | |||
| Materiais Dentários SA. | K161713 | ||
| Dentium CAD/CAM Abutments | |||
| Dentium Co. Ltd. | |||
| Design | |||
| Abutment Design | CAD/CAM Ti-Base | CAD/CAM Blank | |
| CAD/CAM TiBase | CAD/CAM Blank | ||
| CAD/CAM Custom Abutment | |||
| Prosthesis | |||
| Attachment | Cement-retained | ||
| Screw-retained | Cement-retained | ||
| Screw-retained | Cement-retained | ||
| Screw-retained | |||
| Restoration | Single-unit, | ||
| Multi-unit | Single-unit, | ||
| Multi-unit | Single-unit, | ||
| Multi-unit | |||
| Abutment/Implant | |||
| Platform 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/ Implant | |||
| Interface | Internal | Internal | Internal |
| Material | |||
| Abutment | Unalloyed Titanium | ||
| ASTM F67 | Titanium Alloy | ||
| ASTM F136 | Unalloyed Titanium | ||
| ASTM F67 | |||
| Superstructure | Zirconia | ||
| ISO 13356 | Zirconia | ||
| ISO 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.
6
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.