(156 days)
No
The document describes a dental implant system and its components, focusing on materials, dimensions, and mechanical testing. There is no mention of software, algorithms, image processing, or any other technology that would typically incorporate AI/ML.
Yes.
The device is an implant system used for replacing missing teeth, which directly addresses a health condition.
No
This device is an implant system used for surgical procedures to replace missing teeth, not to diagnose a medical condition.
No
The device description lists numerous physical components such as implants, cover screws, healing abutments, and various types of abutments and screws. This clearly indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical procedure involving the placement of a dental implant to replace missing teeth. This is a direct medical intervention on a patient's body.
- Device Description: The device components are physical implants and related prosthetic parts designed to be surgically placed and used within the body.
- 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 screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a medical implant.
N/A
Intended Use / Indications for Use
INNO SLA Submerged Narrow Implant System is intended for two-stage surgical procedures in the following situations and with the following clinical protocols:
-
The intended use for the 3.3mm, 3.5mm diameter INNO Sub Narrow Implant is limited to the replacement of maxillary lateral incisors and mandibular incisors.
-
Immediate placement in extraction situations with a partially or completely healed alveolar ridge.
-
It is intended for delayed loading.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The INNO SLA Submerged Implant System offers the following components.
- INNO SLA Submerged Narrow Fixture (Narrow) Ø 3.3 x 8.00, 10.00, 12.00, 14.00 mm Ø 3.5 x 8.00, 10.00, 12.00, 14.00 mm
- Cover Screw (Narrow) Ø 2.84 x 5.0 mm Ø 3.23 x 6.0 mm Ø 3.62 x 7.0 mm
- Healing Abutment (Narrow) Type 1 Ø3.5 x 6.7, 7.2, 9.2, 10.2, 11.2 mm
- Healing Abutment (Narrow) Type 2 Ø 4.5 x 7, 9, 10, 11, 12, 14 mm
- Cemented Abutment (Narrow) Ø 4.5 x 7.85, 8.85, 9.85, 10.85, 11.85, 12.85, 13.85, 14.85mm Ø 4.5 x 9.35, 10.35, 11.35, 12.35, 13.35 mm Ø 4.5 x 7.65, 8.65, 9.65, 10.65, 11.65, 13.65, 14.65 mm Ø 4.5 x 9.15, 10.15, 11.15, 12.15, 13.15 mm
- Angulated Abutment (Narrow) Ø 4.5 x 11.85, 12.85, 13.85, 14.85 mm (15°, 25°)
- Multi S Abutment Ø 4.5 x 5, 5.8, 6mm
- Multi A Abutment Ø 4.5 x 6.42, 7.42, 8.42, 6.96, 7.96mm (15°,30°) – Hex type Ø 4.5 x 6.23, 7.22, 8.22, 6.76, 7.76mm (15,30°) – Non Hex type
- Multi Hybrid Ti-Base Cylinder Ø 4.5 x 4.5mm
- Abutment Screw (Narrow) Ø 2.25 x 10.2 mm Ø 1.95 x 8.7 mm
- Multi Cylinder Screw Ø 2.25 x 5 mm
- Straight Abutment Ø 3.5 x 13.5, 14, 15, 16, 17 mm
- Temporary Abutment Ø 4.5 x 10 mm
- Multi Titanium Cylinder Ø 4.5 x 9 mm
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary lateral incisors and mandibular incisors, alveolar bone
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.
- Cowellmedi Co., Ltd.'s own clearance K132242 was leveraged for the gamma radiation sterilization, and shelf-life of the dental implants, and K201323 was leveraged for the steam sterilization of the abutments.
- Five-year shelf life and packaging were leveraged from Cowellmedi Co., Ltd's own previous clearance K132242.
- Cowellmedi Co., Ltd.'s own previous clearance K132242 was leveraged for the SLA surface treatment.
- Fatigue test in accordance with ISO 14801
- The biocompatibility endpoints were leveraged from the Cowellmedi Co., Ltd.'s own previous clearance K132242.
- Non-clinical worst-case MRI review was performed to evaluate the subject device components in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., 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 bodies, 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 results: Based on the information and test results provided that the subject device is substantially equivalent to the predicate devices.
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.
K162890, K132242, K201323, K181138, K210117, K160965, K081748, K200817, K201981, K210903, K211952
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
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
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 seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
Cowellmedi Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 18881 Von Karman Ave, Ste. 160 Irvine. California 92612
Re: K231395
Trade/Device Name: INNO SLA Submerged Narrow Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: September 18, 2023 Received: September 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) K231395
Device Name
INNO SLA Submerged Narrow Implant System
Indications for Use (Describe)
INNO SLA Submerged Narrow Implant System is intended for two-stage surgical procedures in the following situations and with the following clinical protocols:
-
The intended use for the 3.3mm, 3.5mm diameter INNO Sub Narrow Implant is limited to the replacement of maxillary lateral incisors and mandibular incisors.
-
Immediate placement in extraction situations with a partially or completely healed alveolar ridge.
-
It is intended for delayed loading.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
510(k) Summary
(K231395)
This summary of 510(k)-safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: ________________________________________________________________________________________________________________________________________________________________________
Applicant / Submitter: 1.
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 Fax: 714-409-3357 Phone: 714-202-5789 Email: juhee.c(@)lkconsultinggroup.com
3. Device:
| Proprietary Name: | INNO SLA Submerged Narrow Implant System |
|---|---|
| Common Name: | Endosseous dental implant |
| Classification Name: | Implant, Endosseous, Root-Form |
| Classification: | Class II, 21 CFR 872.3640 |
| Classification Product Code: | DZE, NHA |
4. Predicate Device:
-
· Primary Predicate Device: UF(II) Narrow Implant System (K161987) by Dio, Inc.
-
· Reference Device:
-
Straumann® Ø2.9 mm Bone Level Tapered Implants (K162890) by Straumann USA, LLC - Healing Abutment for INNO SLA Submerged Implant System (K132242) by Cowellmedi Co., Ltd.
5
-
Angulated Abutment for INNO SLA Submerged Implant System (K201323) by Cowellmedi Co., Ltd.
-
IS-III active System (K181138) by Neobiotech Co., Ltd.
-
Paltop Narrow Implant (K210117) by Paltop Advanced Dental Solutions, Ltd
-
Superline (K160965) by Dentium Co., Ltd.
-
Oneplant Dental Implant System (K081748) by WARANTEC Implant Co., Ltd.
-
URIS OMNI Narrow System & Prosthetic (K200817) by TruAbutment Korea Co., Ltd.
-
Magicore Solid Abutment (K201981) by InnoBioSurg Co., Ltd.
-
Multi Unit Temporary Cylinder (K210903) by Neobiotech Co., Ltd
-
BTI Interna Narrow/Plus Dental Implant System UnicCa (K211952) by B.T.I. Biotechnology Institute, SL
Device Description: 5.
The INNO SLA Submerged Implant System offers the following components.
| No | Component | ||
|---|---|---|---|
| 1 | INNO SLA Submerged Narrow Fixture (Narrow) | ||
| Ø 3.3 x 8.00, 10.00, 12.00, 14.00 mm | |||
| Ø 3.5 x 8.00, 10.00, 12.00, 14.00 mm | |||
| 2 | Cover Screw (Narrow) | ||
| Ø 2.84 x 5.0 mm | |||
| Ø 3.23 x 6.0 mm | |||
| Ø 3.62 x 7.0 mm | |||
| 3 | Healing Abutment (Narrow) | ||
| Type 1 | |||
| Ø3.5 x 6.7, 7.2, 9.2, 10.2, 11.2 mm | |||
| 4 | Healing Abutment (Narrow) | ||
| Type 2 | |||
| Ø 4.5 x 7, 9, 10, 11, 12, 14 mm | |||
| 5 | Cemented Abutment (Narrow) | ||
| Ø 4.5 x 7.85, 8.85, 9.85, 10.85, 11.85, 12.85, 13.85, 14.85mm | |||
| Ø 4.5 x 9.35, 10.35, 11.35, 12.35, 13.35 mm | |||
| Ø 4.5 x 7.65, 8.65, 9.65, 10.65, 11.65, 13.65, 14.65 mm | |||
| Ø 4.5 x 9.15, 10.15, 11.15, 12.15, 13.15 mm | |||
| 6 | Angulated Abutment (Narrow) | ||
| Ø 4.5 x 11.85, 12.85, 13.85, 14.85 mm (15°, 25°) | |||
| 7 | Multi S Abutment | ||
| Ø 4.5 x 5, 5.8, 6mm | |||
| 8 | Multi A Abutment | ||
| Ø 4.5 x 6.42, 7.42, 8.42, 6.96, 7.96mm (15°,30°) – Hex type | |||
| Ø 4.5 x 6.23, 7.22, 8.22, 6.76, 7.76mm (15,30°) – Non Hex type | |||
| 9 | Multi Hybrid Ti-Base Cylinder | ||
| Ø 4.5 x 4.5mm | |||
| 10 | Abutment Screw (Narrow) | ||
| Ø 2.25 x 10.2 mm | |||
| Ø 1.95 x 8.7 mm |
6
| Ø 1.95 x 9.3 mm | |
|---|---|
| 12 | Multi Cylinder Screw |
| Ø 2.25 x 5 mm | |
| 13 | Straight Abutment |
| Ø 3.5 x 13.5, 14, 15, 16, 17 mm | |
| 14 | Temporary Abutment |
| Ø 4.5 x 10 mm | |
| 15 | Multi Titanium Cylinder |
| Ø 4.5 x 9 mm |
દ. Indications for Use:
INNO SLA Submerged Narrow Implant System is intended for two-stage surgical procedures in the following situations and with the following clinical protocols:
-
The intended use for the 3.3mm, 3.5mm diameter INNO Sub Narrow Implant is limited to the replacement of maxillary lateral incisors and mandibular incisors.
-
Immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge.
-
It is intended for delayed loading.
Performance Data (Non-Clinical): 7.
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.
- Cowellmedi Co., Ltd.'s own clearance K132242 was leveraged for the gamma radiation sterilization, and shelf-life of the dental implants, and K201323 was leveraged for the steam sterilization of the abutments.
- Five-year shelf life and packaging were leveraged from Cowellmedi Co., Ltd's own ● previous clearance K132242.
- Cowellmedi Co., Ltd.'s own previous clearance K132242 was leveraged for the SLA ● surface treatment.
- Fatigue test in accordance with ISO 14801
- The biocompatibility endpoints were leveraged from the Cowellmedi Co., Ltd.'s own ● previous clearance K132242
- . Non-clinical worst-case MRI review was performed to evaluate the subject device components in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., 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 bodies, 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.
7
8. Substantial Equivalence
Substantial Equivalence Discussion
The INNO SLA Submerged Narrow Implant ally equivalent to the predicate devices in terms of intended use and technical characteristics. They are made of the same material and have similar design. There are slight differences mostly in abutment size options, however, it is very minor not affecting substantial equivalence.
We have performed the fairgue test to make sure the differences do not raise and the test result of the test supported substantial equivalence.
Based on the information and test results provided that the subject device is substantially equivalent to the predicate devices.
Comparison Chart
| Subject Device | Predicate Device | Reference Device | |
|---|---|---|---|
| 510(k) Number | K231395 | K161987 | K211952 |
| Device Name | INNO SLA Submerged Narrow Implant | ||
| System - Fixture | UF(II) Narrow Implant System | BTI Interna Narrow/Plus Dental Implant | |
| System UnicCa ® | |||
| Manufacturer | Cowellmedi Co., Ltd. | Dio | B.T.I. Biotechnology Institute, SL. |
| Indications for | |||
| Use | The INNO SLA Submerged Narrow | ||
| Implant System is intended for two stage | |||
| surgical procedures in the following | |||
| situations and with the following clinical | |||
| protocols: | |||
| -The intended use for the 3.3mm, 3.5mm | |||
| diameter Narrow Implant is limited to the | |||
| replacement of maxillary lateral incisors | |||
| and mandibular incisors. |
- Immediate placement in extraction sites
and in situations with a partially or
completely healed alveolar ridge.
-It is intended for delayed loading. | The UF(II) Narrow Implant System is
intended for two stage surgical procedures
in the following situations and with the
following clinical protocols:
-The intended use for the 3.0mm, 3.3mm
diameter UF(II) Narrow Implant is limited
to the replacement of maxillary lateral
incisors and mandibular incisors. - Immediate placement in extraction sites
and in situations with a partially or
completely healed alveolar ridge.
-It is intended for delayed loading. | The BTI Dental Implant System UnicCa®
for oral implant surgery is to be used for
the partial or total replacement of teeth in
edentulate patients. Once attached to the
bone, the implants act as an anchor for
various fixed or removable
prosthetic solutions that can be used to
improve or restore a patient's mastication
function.
Tiny® 3.0 UnicCa® implants shall be used
only to replace maxillary lateral incisors
and mandibular lateral and central incisors.
Immediate loading is recommended when
there is good primary stability and an
appropriate occlusal load. |
Fixture ●
8
| Design | Image: Dental Implant | Image: Dental Implant | Image: Dental Implant |
|---|---|---|---|
| Diameter | 3.3. 3.5 mm | 3.0, 3.3mm | 3.3/3.5/3.75/4.0/4.25/4.75 |
| Lengths(mm) | 8, 10, 12, 14mm | 8.5, 10, 11.5, 13, 15mm | 5.5/6.5/7.5/8.5/10/11.5/13/15 |
| Connection | |||
| Interface | Internal Hex | Internal Hex | Internal Hex |
| Non - Submerged | |||
| Surface treatment | SLA | SLA | Calcium surface treatment |
| Sterility | Gamma Sterilization | Gamma Sterilization | Gamma Sterilization |
| Material | Titanium Grade 4 | Titanium Grade 4 | Titanium Grade 4 |
| Principle of | |||
| operation | This product is a root-type fixture which is | ||
| inserted in the alveolar bone. It replaces the | |||
| functions of the missing teeth as a dental | |||
| implant fixture. | This product is a root-type fixture which is | ||
| inserted in the alveolar bone. It replaces the | |||
| functions of the missing teeth as a dental | |||
| implant fixture. | This product is a root-type fixture which is | ||
| inserted in the alveolar bone. It replaces the | |||
| functions of the missing teeth as a dental | |||
| implant fixture. | |||
| Shelf Life | 5 years | 5 years | 5 years |
| Substantial Equivalence Discussion | |||
| The subject device has the same intended use, material, principle of operation, and design as the predicate devices. We identified a reference device | |||
| (K211952) which covers the fixture size range of the subject device. |
9
• Healing Abutment (Type 1)
| Subject Device | Predicate Device | |
|---|---|---|
| 510(k) Number | K231395 | K162890 |
| Device Name | Healing Abutment for | |
| INNO SLA Submerged Narrow Implant | ||
| System | Straumann® Ø2.9 mm Bone Level Tapered | |
| Implants | ||
| Manufacturer | Cowellmedi Co., Ltd. | Straumann USA, LLC |
| Appearance | Image: Healing Abutment | Image: Closure Caps and Healing Abutments |
| Diameter | 3.5 mm | Closure Cap: |
| Ø2.4 mm | ||
| Healing Abutments: | ||
| 3.3/4.3 mm | ||
| 3.55/4.86 mm | ||
| 3.6/5.0 mm | ||
| Post Height | 1, 2mm | - |
| Gingival Height | 0.5, 1, 2, 3, 4mm | Closure Cap: |
| 0.5 mm | ||
| Healing Abutments: | ||
| 2.0, 3.5, 5.0 and 6.5 mm | ||
| Connection | ||
| Interface | Hex, Non-hex | - |
| Surface treatment | N/A | N/A |
| Sterility | Non-sterile; intended for terminal | |
| sterilization via moist heat(autoclave) | Non-sterile; intended for terminal | |
| sterilization via moist heat(autoclave) | ||
| Angulation | 0° | 0° |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Principle of | ||
| operation | The intended use is to protect the inner | |
| configuration of the implant and maintain, | ||
| stabilize and form the soft tissue during the | ||
| healing process. | The intended use is to protect the inner | |
| configuration of the implant and maintain, | ||
| stabilize and form the soft tissue during the | ||
| healing process. | ||
| Substantial Equivalence Discussion | ||
| The subject device has the same intended use, material, and principle of operation as the predicate device. | ||
| The design is slightly different but that does not raise a question in safety or performance. |
10
Healing Abutment (Type 2) •
| Subject Device | Predicate Device | |
|---|---|---|
| 510(k) Number | K231395 | K132242 |
| Device Name | Healing Abutment for | |
| INNO SLA Submerged Narrow Implant | ||
| System | Healing Abutment for | |
| INNO SLA Submerged Implant System | ||
| Manufacturer | Cowellmedi Co., Ltd. | Cowellmedi Co., Ltd. |
| Appearance | Image: Subject Device Appearance | Image: Predicate Device Appearance |
| Diameter | 4.5 mm | 4.1, 4.5, 4.9, 5.5, 5.95, 6.5mm |
| Post Height | 1, 2mm | 2, 3, 4, 5, 6, 7, 9mm |
| Gingival Height | 1, 2, 3, 4, 5, 7mm | 1, 2, 3, 4, 5, 7mm |
| Connection | ||
| Interface | Hex, Non-hex | Hex, Non-hex |
| Surface treatment | N/A | N/A |
| Sterility | Non-sterile; intended for terminal | |
| sterilization via moist heat(autoclave) | Non-sterile; intended for terminal | |
| sterilization via moist heat(autoclave) | ||
| Angulation | 0° | 0° |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Principle of | ||
| operation | This product is a superstructure which is | |
| connects with the fixtures. It replaces the | ||
| functions of the missing teeth as a dental | ||
| abutment. | This product is a superstructure which is | |
| connects with the fixtures using the | ||
| Abutment Screw. It replaces the functions of | ||
| the missing teeth as a dental abutment. | ||
| Substantial Equivalence Discussion | ||
| The subject device has the same intended use, material, principle of operation, and design as the predicate | ||
| device. The wider range is to meet each patient needs and does not raise an issue in performance or safety since | ||
| the size difference is minor. | ||
| • Angulated Abutment | ||
| Subject Device | Predicate Device | |
| 510(k) Number | K231395 | K201323 |
| Device Name | Angulated Abutment for | |
| INNO SLA Submerged Narrow Implant | ||
| System | Angulated Abutment for | |
| INNO SLA Submerged Implant System | ||
| Manufacturer | Cowellmedi Co., Ltd. | Cowellmedi Co., Ltd. |
| Appearance | Image: Angulated Abutment | Image: Angulated Abutment |
| Diameter | 4.5mm | 4.5mm |
| Post Height | 8mm | 5, 8mm |
| Gingival Height | 1, 2, 3, 4mm | 1, 2, 3, 4mm |
| Connection | ||
| Interface | Hex, Non-Hex | Hex, Non-Hex |
| Surface treatment | TiN Coating | TiN Coating |
| Sterility | Non-sterile; intended for terminal | |
| sterilization via moist heat(autoclave) | Non-sterile; intended for terminal | |
| sterilization via moist heat(autoclave) | ||
| Angulation | 15°, 25° | 15°, 25° |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Principle of | ||
| operation | This product is a superstructure which is | |
| connects with the fixtures. It replaces the | This product is a superstructure which is | |
| connects with the fixtures using the |
Angulated Abutment .
11
| functions of the missing teeth as a dental | Abutment Screw. It replaces the functions of | ||
|---|---|---|---|
| abutment. | the missing teeth as a dental abutment. | ||
| Substantial Equivalence Discussion | |||
| The subject device has the same intended use, material, principle of operation, surface treatment, and design as | |||
| the predicate device. The size range of the predicate device encompasses that of the subject device. |
Cemented Abutment ●
| Subject Device | Predicate Device | |
|---|---|---|
| 510(k) Number | K231395 | K181138 |
| Device Name | Cemented Abutment for | |
| INNO SLA Submerged Narrow Implant | ||
| System | IS-III active System | |
| Manufacturer | Cowellmedi Co., Ltd. | Neobiotech Co., Ltd |
| Appearance | Image: Predicate Device | |
| Diameter | 4.5mm | 4.5/5.2/5.7/6.5mm |
| Post | 4/5.5/7mm | 4.0/4.5/5.5/7.0/8.0mm |
| Connection | ||
| Interface | Hex, Non-Hex | Hex, Non-Hex |
| Surface treatment | TiN Coating | TiN Coating |
| Sterility | Non-sterile; intended for terminal | |
| sterilization via moist heat(autoclave) | Non-sterile; intended for terminal | |
| sterilization via moist heat(autoclave) | ||
| Angulation | 0° | 0° |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Principle of | ||
| operation | It is indicated for screw-retained single tooth | |
| or cement retained single tooth and bridge | ||
| restorations. | It is indicated for screw-retained single tooth | |
| or cement retained single tooth and bridge | ||
| restorations. | ||
| Substantial Equivalence Discussion | ||
| The subject device has the same intended use, material, principle of operation, surface treatment, and design as | ||
| the predicate device. The size range of the predicate device encompasses that of the subject device. |
Multi S Abutment ●
| Subject Device | Predicate Device | |
|---|---|---|
| 510(k) Number | K231395 | K210117 |
| Device Name | Multi S Abutment for | |
| INNO SLA Submerged Narrow Implant | ||
| System | Paltop Narrow Implant | |
| Manufacturer | Cowellmedi Co., Ltd. | Paltop Advanced Dental Solutions, Ltd |
| Appearance | Image: Multi S Abutment for INNO SLA Submerged Narrow Implant System | Image: Paltop Narrow Implant |
| Diameter | 4.5mm | 4.5mm |
| G/H | 1/2/3/4/5mm | 1/2/3/4/5mm |
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| Connection
| Interface | Hex | Hex |
|---|---|---|
| Surface treatment | TiN Coating | - |
| Sterility | Non-sterile; intended for terminal | |
| sterilization via moist heat(autoclave) | Non-sterile; intended for terminal | |
| sterilization via moist heat(autoclave) | ||
| Angulation | 0° | 0° |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Principle of | ||
| operation | It is indicated for screw-retained single tooth | |
| or cement retained single tooth and bridge | ||
| restorations. | It is indicated for screw-retained single tooth | |
| or cement retained single tooth and bridge | ||
| restorations. | ||
| Substantial Equivalence Discussion | ||
| The subject device (Multi S Abutment) is substantially equivalent to the predicate device (Multi Abutment, | ||
| K161689). The subject device and the predicate device have the same internal implant interface connections, | ||
| are made of Ti-6Al-4V ELI. There is a slight difference in surface treatment, but it does not raise a concern in | ||
| safety or effectiveness based on our biocompatibility evaluations. |
13
Multi A Abutment ●
| Subject Device | Predicate Device | |
|---|---|---|
| 510(k) Number | K160965 | |
| Device Name | Multi A Abutment for | |
| INNO SLA Submerged Narrow Implant | ||
| System | Superline | |
| Manufacturer | Cowellmedi Co., Ltd. | Dentium Co., Ltd |
| Appearance | Image: Multi A Abutment | Image: Superline |
| Diameter | 4.5mm | 4.5mm |
| G/H | 2,3,4mm | 1/1.5/2/2.5/3/3.5/4/4.5/5/5.5mm |
| Interface | ||
| abutment-implant | Internal | Internal |
| Surface treatment | TiN Coating | Tin Coating |
| Sterility | Non-sterile; intended for terminal | |
| sterilization via moist heat(autoclave) | Non-sterile; intended for terminal | |
| sterilization via moist heat(autoclave) | ||
| Angulation | 15°, 30° | 15°,20°, 30° |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Principle of | ||
| operation | It is indicated for screw-retained single tooth | |
| or cement retained single tooth and bridge | ||
| restorations. | It is indicated for screw-retained single | |
| tooth or cement retained single tooth and | ||
| bridge restorations. | ||
| Substantial Equivalence Discussion | ||
| The subject device (Multi A Abutment) is substantially equivalent to the predicate device. The subject device and | ||
| the predicate device have the same internal implant interface, are made of Ti-6Al-4V ELI. The angulation |
the predicate device have the same internal implant interface connections, are made of Ti-6Al-4V ELI. The size
of the predicate device encompasses that of the subject device.
14
• Multi Hybrid Ti Cylinder
| Subject Device | Predicate Device | |
|---|---|---|
| 510(k) Number | K231395 | K081748 |
| Device Name | Multi Hybrid Ti Cylinder | Oneplant Dental Implant System |
| Manufacturer | Cowellmedi Co., Ltd. | WARANTEC Implant Co., Ltd |
| Appearance | Image: Multi Hybrid Ti Cylinder | Image: Oneplant Dental Implant System |
| Diameter | 4.5mm | Hex/Non-Hex: 4.5/5.5mm |
| Post | 4.5mm | - |
| Sterility | End User Sterilization | End User Sterilization |
| Material | Ti-6Al-4V ELI | Titanium Alloy |
| Principle of operation | Multi Hybrid Ti Cylinder is intended for use in partially or fully edentulous mandibles and maxillae to support for single or multiple-unit restorations such as cemented retained, or over denture restorations and terminal or intermediate abutment support for fixed bridgework. | ONEPLANT is designed for use in dental implant surgery. These are intended for use in partially or fully edentulous mandibles and maxillae to support for single or multiple-unit restorations such as cemented retained, or over denture restorations and terminal or intermediate abutment support for fixed bridgework. |
| Substantial Equivalence Discussion | ||
| The subject device has the same intended use, material, principle of operation, and similar design as the predicate device. |
• Multi Cylinder Screw
| Subject Device | Predicate Device | |
|---|---|---|
| 510(k) Number | K231395 | K200817 |
| Device Name | Multi Cylinder Screw | URIS OMNI Narrow System & Prosthetic |
| Manufacturer | Cowellmedi Co., Ltd. | TruAbutment Korea Co., Ltd |
| Appearance | Image: Multi Cylinder Screw | Image: URIS OMNI Narrow System & Prosthetic |
| Diameter | 2.25mm | 1.6mm |
| Length | 5mm | 3.3 mm |
| Sterility | End User Sterilization | End User Sterilization |
| Material | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI (ASTM F136) |
| Principle of | ||
| operation | Multi-unit Cylinder Screw is a | |
| premanufactured prosthetic component | ||
| directly connected to the endosseous dental | Multi-unit Cylinder Screw is a | |
| premanufactured prosthetic component | ||
| directly connected to the endosseous dental |
15
| | implant and is intended for use as an aid in
prosthetic rehabilitation. | implant and is intended for use as an aid in
prosthetic rehabilitation. |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Substantial Equivalence Discussion | | |
| The subject device has the same intended use, material, principle of operation, and design as the predicate
device. There is a slight difference in size, but it does not raise a concern in safety or effectiveness. | | |
| • Straight Abutment | ||
|---|---|---|
| Subject Device | Predicate Device | |
| 510(k) Number | K231395 | K201981 |
| Device Name | Straight Abutment | Magicore Solid Abutment |
| Manufacturer | Cowellmedi Co., Ltd. | InnoBioSurg Co., Ltd. |
| Appearance | Image: Straight Abutment | Image: Magicore Solid Abutment |
| Diameter | 3.5mm | 3.5/3.86/4.3/4.6mm |
| Post | 8mm | 7.6/8.6/9.6/10.6/11.6 mm |
| Sterility | End User Sterilization | End User Sterilization |
| Material | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI (ASTM F136) |
| Principle of | ||
| operation | Straight Abutment is intended for use with a | |
| dental implant to provide support for | ||
| prosthetic restorations such as crowns, | ||
| bridges, or overdentures. | Straight Abutment is intended for use with a | |
| dental implant to provide support for | ||
| prosthetic restorations such as crowns, | ||
| bridges, or overdentures. | ||
| Substantial Equivalence Discussion | ||
| The subject device has the same intended use, material, principle of operation, and similar design as the | ||
| predicate device. The size range of the predicate device encompasses that of the subject device. |
Temporary Abutment ●
| Subject Device | Predicate Device | |
|---|---|---|
| 510(k) Number | K231395 | K181138 |
| Device Name | Temporary Abutment | IS-III active System |
| Manufacturer | Cowellmedi Co., Ltd. | Neobiotech Co., Ltd |
| Appearance | Image: Subject Device Appearance | Image: Predicate Device Appearance |
| Diameter | 4.5mm | 4.5mm |
| Post | 10mm | 6.0/8.0/11.5 mm |
| Sterility | End User Sterilization | End User Sterilization |
| Material | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI (ASTM F136) |
| Principle of operation | It is dental Abutments designed to serve as a | |
| temporary dental prosthesis during the | ||
| healing process until a permanent crown is | ||
| made. | It is dental Abutments designed to serve as a | |
| temporary dental prosthesis during the | ||
| healing process until a permanent crown is | ||
| made. | ||
| Substantial Equivalence Discussion |
16
The subject device has the same intended use, material, principle of operation, and similar design as the predicate device. The size range of the predicate device encompasses that of the subject device.
17
•
| Subject Device | 1st Predicate Device | 2nd Predicate Device | |
|---|---|---|---|
| 510(k) Number | K231395 | K210117 | K210903 |
| Device Name | Multi Titanium Cylinder | Multi-Unit Cylinder | Multi Unit Temporary Cylinder |
| Manufacturer | Cowellmedi Co., Ltd. | Paltop Advanced Dental Solutions, Ltd | Neobiotech Co., Ltd |
| Appearance | Image: Subject Device | Image: 1st Predicate Device | Image: 2nd Predicate Device |
| Diameter | 4.5mm | 4.5mm | 4.8/6.0mm |
| Post | 9mm | - | 11mm |
| Angle | 0° | 0° | 0° |
| Sterility | End User Sterilization | End User Sterilization | End User Sterilization |
| Material | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI (ASTM F136) |
| Principle of | |||
| operation | Multi Titanium Cylinder is designed to | ||
| serve as a temporary dental prosthesis | |||
| during the healing process until a | |||
| permanent bridges are made. | - | It is designed to serve as a temporary | |
| dental prosthesis during the healing process | |||
| until a permanent bridges are made. | |||
| Duration of Use | 90 days | - | 90 days |
| Substantial Equivalence Discussion | |||
| The subject device has the same diameter size as the first predicate device. The subject device has the same intended use, material, principle of operation, | |||
| and similar design as the second predicate device. |
18
Conclusion: 9.
Based on the testing results, Cowellmedi Co., Ltd. concludes that the INNO SLA Submerged Narrow Implant System is substantially equivalent to the predicate devices.