(218 days)
No
The summary describes a physical dental implant system and its components, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is a component of a dental implant system (Ti-Base) used to support restorations, not to treat or cure a disease or condition itself.
No
The device is an implant system used for supporting dental restorations, not for diagnosing medical conditions.
No
The device description clearly outlines physical components made of titanium alloy and zirconia, and the performance studies include testing on sterilization, biocompatibility, fatigue, and MRI compatibility, all of which are relevant to hardware devices. While it mentions CAD/CAM design, this is for the creation of a physical superstructure, not the device itself being purely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for supporting dental restorations in the mouth (mandibles and maxillae). This is a direct interaction with the patient's body for a therapeutic purpose (restoring dental function and aesthetics).
- Device Description: The description details a physical implant system made of titanium and zirconia, designed to be surgically placed and support a dental prosthesis.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are typically used in a laboratory setting or at the point of care to analyze biological samples.
The device described is a dental implant system component, which falls under the category of medical devices used for surgical and prosthetic purposes, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
INNO SLA Submerged Hybrid Ti-Base System is intended for use in conjunction with the fixture in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit cement retained restorations. All digitally designed zirconia superstructures for use with the INNO SLA Submerged Hybrid Ti-Base System are intended to be sent to a Cowellmedi validated milling center for manufacture.
Product codes
NHA
Device Description
INNO SLA Submerged Hybrid Ti-Base System consists of a two-piece abutment, where the titanium base is a pre-manufactured abutment that will be used to support a CAD/CAM designed superstructure (the second part of the two-piece abutment). These two pieces together form the final abutment. Ti-base Abutment System is made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications. The zirconia material is InCoris Zi, cleared under K123664, and the cement is RelyX Unicem 2Automiz, cleared under K100756. Zirconia CAD/CAM abutment or superstructure that composes the final prosthetics is intended to be designed and milled, according to the prosthetic planning and patient clinical situation. It is compatible with the following systems: INNO SLA Submerged Implant System(K132242) by Cowellmedi Co., Ltd. The system offers the following three types of Ti-Base with a screw that fix the abutment into the fixture: Hybrid S Ti-Base, Hybrid L Ti-Base, Hybrid A Ti-Base.
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)
The following tests were performed on the subject device and the test results support that the subject device is substantially equivalent to the predicate devices: Sterilization validating testing has been performed in accordance with ISO 17665-1 and ISO 17665-2 for steam sterilization. Biocompatibility testing has been performed in accordance with ISO 10993-3, 5, 6, 10, 11, and 23. Fatigue test in accordance with ISO 14801. Non-clinical worst-case MRI review was performed to evaluate the INNO SLA Submerged Hybrid Ti-Base System in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry 0., Jana G. Delfino, and Sunder Rajan. 'Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodied, dental abutments and, fixation screws) and material composition. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.)
0
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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.
December 20, 2023
Cowellmedi Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 18881 Von Karman Ave, STE 160 Irvine. California 92612
Re: K231411
Trade/Device Name: INNO SLA Submerged Hybrid Ti-Base System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: November 20, 2023 Received: November 21, 2023
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 (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.
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
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
510(k) Number (if known) K231411
Device Name
INNO SLA Submerged Hybrid Ti-Base System
Indications for Use (Describe)
INNO SLA Submerged Hybrid Ti-Base System is intended for use in conjunction with the fixture in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit cement retained restorations. All digitally designed zirconia superstructures for use with the INNO SLA Submerged Hybrid Ti-Base System are intended to be sent to a Cowellmedi 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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4
510(k) Summary (K231411)
This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: __ Dec 19, 2023___
1. Applicant / Submitter:
Cowellmedi Co., Ltd. 48, Hakgam-daero 221beon-gil, Sasang-gu, Busan, 46986, Republic of Korea Tel. + 82-51-314-2028
2. Submission Correspondent:
Priscilla Chung LK Consulting Group USA, Inc. 18881 Von Karman Ave STE 160 Irvine CA 92612 Phone: 714-202-5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com
3. Device:
| Proprietary Name: | INNO SLA Submerged Hybrid Ti-Base System |
|---|---|
| Common Name: | Dental Abutment |
| Classification Name: | Endosseous Dental Implant Abutment |
| Classification: | Class II, 21 CFR 872.3630 |
| Classification Product Code: | NHA |
4. Predicate Device:
- · Primary Predicate Device: URIS Base (K200817) by TruAbutment Korea Co., Ltd.
- · Reference Device: Preat Abutment (K183518) by Preat Corporation
- · Reference Device: BioHorizons CAD/CAM Abutments (K151621) by BioHorizons Implant Systems, Inc.
5
5. Device Description:
INNO SLA Submerged Hybrid Ti-Base System consists of a two-piece abutment, where the titanium base is a pre-manufactured abutment that will be used to support a CAD/CAM designed superstructure (the second part of the two-piece abutment). These two pieces together form the final abutment. Ti-base Abutment System is made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications. The zirconia material is InCoris Zi, cleared under K123664, and the cement is RelyX Unicem 2Automiz, cleared under K100756. Zirconia CAD/CAM abutment or superstructure that composes the final prosthetics is intended to be designed and milled, according to the prosthetic planning and patient clinical situation. It is compatible with the following systems:
-
· INNO SLA Submerged Implant System(K132242) by Cowellmedi Co., Ltd.
The system offers the following three types of Ti-Base with a screw that fix the abutment into the fixture. -
· Hybrid S Ti-Base
-
· Hybrid L Ti-Base
-
· Hybrid A Ti-Base
6. Indications for Use:
INNO SLA Submerged Hybrid Ti-Base System is intended for use in conjunction with the fixture in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit cement retained restorations. All digitally designed zirconia superstructures for use with the INNO SLA Submerged Hybrid Ti-Base System are intended to be sent to a Cowellmedi validated milling center for manufacture.
7. Performance Data (Non-Clinical):
The following tests were performed on the subject device and the test results support that the subject device is substantially equivalent to the predicate devices.
- . Sterilization validating testing has been performed in accordance with ISO 17665-1 and ISO 17665-2 for steam sterilization.
- Biocompatibility testing has been performed in accordance with ISO 10993-3, 5, 6, 10, 11, ● and 23.
- . Fatigue test in accordance with ISO 14801
- MR Environment Condition ●
Non-clinical worst-case MRI review was performed to evaluate the INNO SLA Submerged Hybrid Ti-Base System in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry 0., Jana G. Delfino, and Sunder Rajan. 'Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodied, dental abutments and,
6
fixation screws) and material composition. 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.
7
8. Substantial Equivalence
Comparison Chart
| Subject Device | Primary Predicate Device | Reference Device | |||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 510(K) No. | K231411 | K200817 | K183518 | K151621 | |||||||||||||||||||||||||||||||||||||||
| Applicant | Cowellmedi Co., Ltd. | TruAbutment Korea Co., Ltd. | Preat Corporation | BioHorizons Implant Systems, Inc. | |||||||||||||||||||||||||||||||||||||||
| Trade Name | INNO SLA Submerged Hybrid Ti- | ||||||||||||||||||||||||||||||||||||||||||
| Base System | URIS Base | Preat Abutment | BioHorizons CAD/CAM Abutments | ||||||||||||||||||||||||||||||||||||||||
| Classification | |||||||||||||||||||||||||||||||||||||||||||
| Name | Endosseous Dental Implant | ||||||||||||||||||||||||||||||||||||||||||
| Abutments (872.3630) | Endosseous Dental Implant | ||||||||||||||||||||||||||||||||||||||||||
| Abutments (872.3630) | Endosseous Dental Implant | ||||||||||||||||||||||||||||||||||||||||||
| Abutments (872.3630) | Endosseous Dental Implant | ||||||||||||||||||||||||||||||||||||||||||
| Abutments (872.3630) | |||||||||||||||||||||||||||||||||||||||||||
| Product Code | NHA | NHA | NHA | NHA | |||||||||||||||||||||||||||||||||||||||
| Material | Ti-6Al-4V ELI (ASTM F136) | ||||||||||||||||||||||||||||||||||||||||||
| Zirconia Oxide | Ti-6Al-4V ELI (ASTM F136) | ||||||||||||||||||||||||||||||||||||||||||
| Zirconia Oxide | Ti-6Al-4V ELI (ASTM F136) | ||||||||||||||||||||||||||||||||||||||||||
| Zirconia Oxide | Ti-6Al-4V (ASTM F136); | ||||||||||||||||||||||||||||||||||||||||||
| additionally, Y-TZP Ceramic for | |||||||||||||||||||||||||||||||||||||||||||
| Titanium Base Abutment | |||||||||||||||||||||||||||||||||||||||||||
| Indications | |||||||||||||||||||||||||||||||||||||||||||
| For Use/ | |||||||||||||||||||||||||||||||||||||||||||
| Intended Use | INNO SLA Submerged Hybrid Ti- | ||||||||||||||||||||||||||||||||||||||||||
| Base System is intended for use in | |||||||||||||||||||||||||||||||||||||||||||
| conjunction with the fixture in | |||||||||||||||||||||||||||||||||||||||||||
| partially or fully edentulous | |||||||||||||||||||||||||||||||||||||||||||
| mandibles and maxillae, in support | |||||||||||||||||||||||||||||||||||||||||||
| of single or multiple-unit cement | |||||||||||||||||||||||||||||||||||||||||||
| retained restorations. All digitally | |||||||||||||||||||||||||||||||||||||||||||
| designed zirconia superstructures | |||||||||||||||||||||||||||||||||||||||||||
| for use with the INNO SLA | |||||||||||||||||||||||||||||||||||||||||||
| Submerged Hybrid Ti-Base System | |||||||||||||||||||||||||||||||||||||||||||
| are intended to be sent to a | |||||||||||||||||||||||||||||||||||||||||||
| Cowellmedi validated milling | |||||||||||||||||||||||||||||||||||||||||||
| center for manufacture. | URIS OMNI Narrow System is | ||||||||||||||||||||||||||||||||||||||||||
| indicated for use in the treatment | |||||||||||||||||||||||||||||||||||||||||||
| of missing maxillary lateral | |||||||||||||||||||||||||||||||||||||||||||
| incisors or the mandibular central | |||||||||||||||||||||||||||||||||||||||||||
| and lateral incisors, in support of | |||||||||||||||||||||||||||||||||||||||||||
| single or multiple-unit restorations | |||||||||||||||||||||||||||||||||||||||||||
| including: cemented retained, | |||||||||||||||||||||||||||||||||||||||||||
| screw retained, | |||||||||||||||||||||||||||||||||||||||||||
| or overdenture restorations, and | |||||||||||||||||||||||||||||||||||||||||||
| final or temporary abutment | |||||||||||||||||||||||||||||||||||||||||||
| support for fixed bridgework. It is | |||||||||||||||||||||||||||||||||||||||||||
| intended for delayed loading. | |||||||||||||||||||||||||||||||||||||||||||
| The URIS OMNI Prosthetic | |||||||||||||||||||||||||||||||||||||||||||
| abutments are intended for use | |||||||||||||||||||||||||||||||||||||||||||
| with URIS OMNI dental implants | |||||||||||||||||||||||||||||||||||||||||||
| to provide support for prosthetic | |||||||||||||||||||||||||||||||||||||||||||
| restorations such as crowns, | |||||||||||||||||||||||||||||||||||||||||||
| bridges, or over-dentures. | |||||||||||||||||||||||||||||||||||||||||||
| All digitally designed abutments | |||||||||||||||||||||||||||||||||||||||||||
| and/or coping for use with URIS | |||||||||||||||||||||||||||||||||||||||||||
| OMNI Prosthetic abutments are | Preat Abutments are intended to be used in conjunction with endosseous dental implants in | ||||||||||||||||||||||||||||||||||||||||||
| the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic | |||||||||||||||||||||||||||||||||||||||||||
| restorations. | |||||||||||||||||||||||||||||||||||||||||||
| All digitally designed custom abutments for use with Titanium Base or Titanium Blank are | |||||||||||||||||||||||||||||||||||||||||||
| to be sent to a Preat validated milling center for manufacture. |
Compatible Implant Systems
Compatible Implant SystemImplant Body Diameter (mm)Implant Platform Diameter (mm)3i OSSEOTITE Certain3.25
4.0
5.0
6.04.1
4.3
5.0
6.0Astra Tech OsteoSpeed™3.0
3.5,4.0
4.5,5.03.0
3.5/4.0
4.5/5.0BioHorizons Tapered Internal3.0
3.5
4.03.0
3.5
4.5HIOSSEN ET III3.5
4.0, 4.5, 5.0, 6.0, 7.0Mini
RegularImplant Direct Legacy3.2
3.7,4.2
4.7,5.2
5.7,7.03.0
3.5
5.0
5.7MegaGen AmyRidge3.5, 4.0, 4.5, 5.0, 5.53.5Neoss3.5, 4.0, 4.5, 5.0, 5.53.5NobelActive3.5
4.3, 5.0NP
RFNobel Replace™3.5
4.0,4.3,5.0
5.0
6.0NP
WP
5.0
6.0Straumann Bone Level3.3
4.1,4.8NC
RNStraumann Tissue Level3.3, 4.1, 4.8
4.8,6.5NC
WNZimmer Screw-Vent/Tapered Screw-Vent3.3,3.7,4.1
4.7
6.03.5
4.7
5.7 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | All digitally designed abutments
and/or copings for use with
BioHorizons CAD/CAM Abutments
are intended to be sent to a
BioHorizons-validated milling
center for manufacture.
BioHorizons abutments designed
using CAD/CAM techniques must
fulfill the BioHorizons allowable
range of design parameters. |
8
| Subject Device | Primary Predicate Device | Reference Device | |
|---|---|---|---|
| intended to be sent to a | |||
| TruAbutment-validated milling | |||
| center for manufacture. | |||
| 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/Im | |||
| plant | |||
| Platform | |||
| Diameter | |||
| (mm) | 3.5~6 mm | Narrow 2.6 | |
| Regular 3.3 | 3.0~6.5mm | ||
| Design Limits | |||
| (Min.~Max.) | Maximum Angulation 20° | ||
| Maximum Cuff Height 5.0mm | |||
| Minimum Gingival Height, 0.5mm | |||
| Minimum Diameter Ø 5.0mm | |||
| Minimum Thickness 0.4mm | |||
| Minimum Post Height 4.0mm | Maximum Angulation 15° | ||
| Maximum Cuff Height 5mm | |||
| Minimum Diameter Ø 5.0mm | |||
| Minimum Thickness 0.4mm | |||
| Minimum Post Height 4~6mm | Maximum Angle 30° | ||
| Minimum Thickness 0.5 mm | |||
| Minimum Post Height for single- | |||
| unit restoration 4.0 mm | |||
| Maximum Gingival Height 1.5 mm | |||
| to 2.65 mm (varies by implant line). | |||
| Abutment/ | |||
| Implant | |||
| Interface | Internal Connection | Internal Connection | Internal Connection |
| Sterile | Non-sterile | Non-sterile | Non-sterile |
Substantial Equivalence Discussion
The subject device (NNO SLA Submerged Hybrid Ti-Base System) is substantially equivalent to the primary predicate device (URIS Base, K200817). The subject device and the predicate device have and similar technological characteristics. The wording of the indications for use statement between the subject and the predicate devices is slightly different, however, the fundamental intended use is the same and has no difference. They are made of Ti-6A1-4V ELI, and have similar interface connections, and use similar material for restoration. Both dentical design parameters except for angle. We identified reference devices which cover the size of the angle range of the subject device. We also perform faigue testing, and the result supports that the substantially equivalent to the predicate device in the market.
9
Conclusion: 9.
Based on the testing results, Cowellmedi Co., Ltd. concludes that the INNO SLA Submerged Hybrid Ti-Base System is substantially equivalent to the predicate devices.