(355 days)
No
The summary describes a physical dental implant system and its components, materials, and dimensions. There is no mention of software, algorithms, image processing, or any terms related to AI or ML.
Yes
Explanation: The device is an implant system used to support restorations in mandibles and maxillae, which directly treats anatomical defects or provides functional support to the body.
No
Justification: The device description and intended use clearly state that this is an implant system used for supporting dental restorations, which is a therapeutic function, not a diagnostic one. No mention of diagnostic capabilities, imaging, or analysis of patient data for diagnostic purposes is present.
No
The device description clearly outlines various physical components made of materials like Ti 6A1 4V ELI and POLYAMIDE 6.6, including dental fixtures, abutments, and screws with specific dimensions and surface treatments. This indicates a hardware-based medical device, not a software-only one.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "use in support of single or multiple-unit restorations and partial or fully edentulous mandibles and maxilla." This describes a surgical implant for dental reconstruction, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details the physical components of a dental implant system (fixtures, abutments, screws, etc.) and their materials and dimensions. This aligns with a medical device intended for implantation, not an IVD.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, calibrators, controls, or any other elements typically associated with in vitro diagnostics.
- Performance Studies: The performance studies described focus on biocompatibility, sterilization, fatigue, and accelerated aging, which are relevant to implanted medical devices, not IVDs.
Therefore, the CSM Submerged3-L Implant System is a medical device, specifically a dental implant system, and not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The CSM Submerged3-L Implant System is intended for use in support of single or multiple-unit restorations and partial or fully edentulous mandibles and maxilla. This system is intended for delayed loading.
Product codes
DZE, NHA
Device Description
The CSM Submerged3-L Implant System is composed of dental fixtures (Sub3 Fixture) and various abutments such as Healing Abutment, Cementation Abutment (Hex, Non-Hex), Angled Abutment (Hex, Non-Hex), Abutment Screw, Submerged Cover Screw, Retainer Abutment, Retainer Cap, Retainer Retention Male, and Temporary Abutment (Hex, Non-Hex).
There is no vertical anti-rotation slot in our fixtures. When it comes to anti-rotational feature, it is 11 °, which is internal hexagonal feature. Hence. 4.0. 4.8. 5.2. 5.6. 6.0 size fixtures have 2.5 hexagonal features, different from fixture with 3.6 diameter, which has 2.1 double hexagonal feature. The fin of submerged 3 fixtures is V-shape. In addition, a straight flat axial surface is on our fixture, functioning as tapering part.
In case of abutments, 2.5 and 2.1 hexagonal features are usually used.
The Sub3 fixtures and screws are made of Ti 6A1 4V ELI (Conforming to ASTM Standard F-136) and dental abutment is made of Ti-6A1-4V ELI (ASTM F136), POLYAMIDE 6.6.
The surface of the fixtures is treated with RBM (Resorbable Blast Media) and Laser.
The diameters of the CSM Submerged3-L Implants are Ø 3.62mm, 4.35mm, 4.75mm, 5.15mm, 5.55mm, 5.95mm and the lengths of the CSM Submerged3-L Implants are 7.3mm, 8.3mm, 9.3mm, 10.3mm, 11.3mm, 12.3mm, 13.3mm, 14.3mm.
The dimension of each abutment ranges as below:(The tolerance of all products is ±0.03)
- Healing Abutment: Ø 4.02mm, 4.5mm, 6.5mm (D) X 8.25mm, 8.75mm, 9.75mm, ● 10.35mm, 10.75mm, 11.75mm, 12.35mm, 12.75mm (L)
- Cementation Abutment: Ø 4.5mm, 5.5mm, 6.5mm (D) X 8.0mm, 8.5mm, 9.0mm, 9.5mm, ● 10.5mm, 11.5mm, 12.5mm, 13.5mm (L)
- Angled Abutment: Ø 4.0mm, 4.5mm, 5.5mm (D) X 9.0mm, 9.5mm, 10.0mm, 10.3mm, ● 10.4mm, 10.5mm, 11.3mm, 11.5mm, 12.3mm, 12.3mm, 13.3mm, 13.5mm (L) with 15° and 20°
- . Abutment Screw: Ø 2.1mm, 2.33mm (D) X 8.3mm, 10.0mm (L)
- Submerged Cover Screw: Ø 2.83mm, 3.33mm (D) X 6.0mm, 6.5mm (L) ●
- Retainer Abutment: Ø 3.9mm (D) X 7.15mm, 7.65mm, 7.9mm, 8.65mm, 8.9mm, ● 9.65mm, 9.9mm, 10.65mm, 10.9mm, 11.65mm, 11.9mm, 12.9mm, 13.65mm, 13.9mm, 14.65mm, 14.9mm, 15.65mm, 15.9mm, 16.65mm, 16.9mm (L)
- Retainer Cap: Ø 5.45mm (D) X 2.4mm (L) ●
- Retainer Retention Male: Ø 4.7mm (D) X 1.85mm, 2.06mm (L) ●
- Temporary Abutment: Ø 4.5mm, 5.5mm (D) X 12.8mm, 13.8mm, 13.8mm, 14.8mm, 15.8mm, ● 16.8mm (L)
The implant-abutment connection is internal hex and Morse taper level.
Implant-fixture and submerged cover screw are packed together and provided sterile. The abutments are provided non-sterile and must be sterilized before use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandibles and maxilla
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)
Non-Clinical Data:
The subject device was tested to evaluate its substantial equivalence according to the following standards.
- End User Steam Sterilization Test according to ISO 17665-1:2006, -2:2009 and ANSI/AAMI ST79
- Biocompatibility Test such as cytotoxicity according to ISO 10993-5:2009, irritation according to ISO 10993-10:2010, sensitization according to ISO 10993-10:2010, acute systemic according to ISO 10993-11:2006, and genotoxicity according to ISO 10993-3:2014.
Below tests were performed for predicate devices and leveraged for the subject device:
- Sterilization Validation Test according to ISO 11137-1,2,3 referenced in K102635.
- Fatigue Test according to ISO 14801 referenced in K102635.
- Accelerated Aging Test (Shelf Life Test) according to ASTM F1980-07 referenced in K102635.
The end user sterilization test was performed for the subject abutments. The sterilization validation test was performed for the predicate, K102635 and leveraged for the subject product because the product material, sterilization site, sterilization method, SAL, sterilization parameters are exactly identical to the predicate, K102635. The biocompatibility tests were performed on the subject device and it demonstrated the subject device is biocompatible. The accelerated aging testing was performed for predicate device, K102635 and leveraged for the subject device because the product category, material, manufacturing process, facility, packaging material and packaging procedure are the exactly the same as the predicate, K102635. The fatigue testing was performed for the predicate device. K102635 and leveraged for the subject device because we compared the worst-case implants and the test sample from K102635 was the worst. Therefore, it supports mechanical properties. The results of the above tests have met the criteria of the standards, and demonstrated the substantial equivalence with the predicate device and are compliant with Guidance of "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant and Endosseous Dental Implant abutments".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K143022, K120043, K081575, K112787
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
September 19, 2019
CSM Implant % April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620
Re: K173141
Trade/Device Name: CSM Submerged3-L Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: August 17, 2018 Received: August 22, 2018
Dear April Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/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 -S3
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K173141
Device Name CSM Submerged3-L Implant System
Indications for Use (Describe)
The CSM Submerged3-L Implant System is intended for use in support of single or multiple-unit restorations and partial or fully edentulous mandibles and maxilla. This system 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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3
510(k) Summary
Submitter
CSM Implant Sung Am Cho B205 Techno B/D, Kyung-Pook National Univ. 47, Gyeongdae-ro 17gil, Buk-gu, Daegu 41566 Republic of Korea Email: niceunhurried@aol.com Tel. +82- 53-952-8261 Fax. +82- 53-958-8261
Device Information
Official Correspondent
Withus Group Inc April Lee 106 Superior, Irvine, CA 92620 USA Email: withus6664@gmail.com Phone: 1-909-274-9971 Fax: 1-909-460-8122
- . Trade Name: CSM Submerged3-L Implant System
- . Common Name: Endosseous dental implant
- Classification Name: Endosseous dental implant
- Primary Product Code: DZE
- Secondary Product Code: NHA
- Panel: Dental
- Regulation Number: 872.3640
- Device Class: Class II
- . Date prepared: 09/17/2018
Predicate Information
Primary Predicate: K102635, CSM Submerged-L Implant System by CSM Implant
Reference Predicate: K143022, BioHorizons Tapered Internal Implants by BioHorizons Implant System Inc. K120043, CSM Internal-R Implant System by CSM Implant K081575, HU/HS/HG PROSTHETIC SYSTEM by Osstem Implant K112787, Karator by KJ Meditech Co, Ltd.
Device Description
The CSM Submerged3-L Implant System is composed of dental fixtures (Sub3 Fixture) and various abutments such as Healing Abutment, Cementation Abutment (Hex, Non-Hex), Angled Abutment (Hex, Non-Hex), Abutment Screw, Submerged Cover Screw, Retainer Abutment, Retainer Cap, Retainer Retention Male, and Temporary Abutment (Hex, Non-Hex).
There is no vertical anti-rotation slot in our fixtures. When it comes to anti-rotational feature, it is 11 °, which is internal hexagonal feature. Hence. 4.0. 4.8. 5.2. 5.6. 6.0 size fixtures have 2.5 hexagonal features, different from fixture with 3.6 diameter, which has 2.1 double hexagonal feature. The fin of submerged 3 fixtures is V-shape. In addition, a straight flat axial surface is on our fixture, functioning as tapering part.
4
In case of abutments, 2.5 and 2.1 hexagonal features are usually used.
The Sub3 fixtures and screws are made of Ti 6A1 4V ELI (Conforming to ASTM Standard F-136) and dental abutment is made of Ti-6A1-4V ELI (ASTM F136), POLYAMIDE 6.6.
The surface of the fixtures is treated with RBM (Resorbable Blast Media) and Laser.
The diameters of the CSM Submerged3-L Implants are Ø 3.62mm, 4.35mm, 4.75mm, 5.15mm, 5.55mm, 5.95mm and the lengths of the CSM Submerged3-L Implants are 7.3mm, 8.3mm, 9.3mm, 10.3mm, 11.3mm, 12.3mm, 13.3mm, 14.3mm.
The dimension of each abutment ranges as below:(The tolerance of all products is ±0.03)
- Healing Abutment: Ø 4.02mm, 4.5mm, 6.5mm (D) X 8.25mm, 8.75mm, 9.75mm, ● 10.35mm, 10.75mm, 11.75mm, 12.35mm, 12.75mm (L)
- Cementation Abutment: Ø 4.5mm, 5.5mm, 6.5mm (D) X 8.0mm, 8.5mm, 9.0mm, 9.5mm, ● 10.5mm, 11.5mm, 12.5mm, 13.5mm (L)
- Angled Abutment: Ø 4.0mm, 4.5mm, 5.5mm (D) X 9.0mm, 9.5mm, 10.0mm, 10.3mm, ● 10.4mm, 10.5mm, 11.3mm, 11.5mm, 12.3mm, 12.3mm, 13.3mm, 13.5mm (L) with 15° and 20°
- . Abutment Screw: Ø 2.1mm, 2.33mm (D) X 8.3mm, 10.0mm (L)
- Submerged Cover Screw: Ø 2.83mm, 3.33mm (D) X 6.0mm, 6.5mm (L) ●
- Retainer Abutment: Ø 3.9mm (D) X 7.15mm, 7.65mm, 7.9mm, 8.65mm, 8.9mm, ● 9.65mm, 9.9mm, 10.65mm, 10.9mm, 11.65mm, 11.9mm, 12.9mm, 13.65mm, 13.9mm, 14.65mm, 14.9mm, 15.65mm, 15.9mm, 16.65mm, 16.9mm (L)
- Retainer Cap: Ø 5.45mm (D) X 2.4mm (L) ●
- Retainer Retention Male: Ø 4.7mm (D) X 1.85mm, 2.06mm (L) ●
- Temporary Abutment: Ø 4.5mm, 5.5mm (D) X 12.8mm, 13.8mm, 13.8mm, 14.8mm, 15.8mm, ● 16.8mm (L)
The implant-abutment connection is internal hex and Morse taper level.
Implant-fixture and submerged cover screw are packed together and provided sterile. The abutments are provided non-sterile and must be sterilized before use.
Indication for Use
The CSM Submerged3-L Implant System is intended for use in support of single or multiple-unit restorations and partial or fully edentulous mandibles and maxilla. This system is intended for delayed loading.
Materials:
The Sub3 fixtures and screws are made of Ti-6Al-4V ELI (Conforming to ASTM Standard F136-13) and dental abutments are made of Ti-6AI-4V ELI (Conforming to ASTM Standard F136-13), POLYAMIDE 6.6.
5
Summary of Technological Characteristics
1) Fixtures
| 1) Fixtures | ||||
|---|---|---|---|---|
| Subject Device | Primary Predicate | Reference Predicate | ||
| 510(K) Number | K173141 | K102635 | K143022 | |
| Device Name | CSM Submerged3-L | |||
| Implant System | CSM Submerged-L | |||
| Implant System | BioHorizons Tapered Internal | |||
| Implants | ||||
| Manufacturer | CSM Implant | CSM Implant | BioHorizons | |
| Implant Systems, Inc. | ||||
| Indications for Use | The CSM Submerged3-L | |||
| Implant System is | ||||
| intended for use in | ||||
| support of single or | ||||
| multiple-unit restorations | ||||
| and partial or fully | ||||
| edentulous mandibles | ||||
| and maxilla. This system | ||||
| is intended for delayed | ||||
| loading. | CSM Implants are | |||
| intended for use in | ||||
| support of single or | ||||
| multiple-unit restorations | ||||
| and partial or fully | ||||
| edentulous mandibles | ||||
| and maxilla. This system | ||||
| is intended for delayed | ||||
| loading. | Bio Horizons Tapered Internal | |||
| Implants are intended for use in | ||||
| the mandible or maxilla as an | ||||
| artificial root structure for single | ||||
| tooth replacement or for fixed | ||||
| bridgework and dental retention. | ||||
| Bio Horizons Tapered Internal | ||||
| Implants may be restored | ||||
| immediately | ||||
| I) with a temporary prosthesis | ||||
| that is not in | ||||
| functional occlusion, or |
- when splinted together for
multiple tooth replacement, or
when stabilized with an
overdenture supported by
multiple implants |
| | Appearance | Image: CSM Submerged3-L Implant | Image: CSM Submerged-L Implant | Image: BioHorizons Tapered Internal Implant |
| | Material | Ti-6Al-4V ELI
(ASTM-F136) | Ti-6Al-4V ELI
(ASTM-F136) | Ti-6Al-4V ELI (ASTM-F136) |
| | Sterilization | Gamma | Gamma | Gamma |
| | Surface Treatment | RBM(Resorbable
Blasting Media) + Laser | RBM(Resorbable
Blasting Media) + Laser | Implant- RBT
Collar- Laser-Lok or RBT |
| Implant | Diameter | 3.62mm, 3.95mm,
4.35mm, 4.75mm,
5.15mm,5.55mm,
5.95mm | 3.5-6.0mm | 3.4mm, 3.8mm, 4.6mm |
| | Length | 7.3mm, 8.3mm, 9.3mm,
10.3mm, 11.3mm,
12.3mm, 13.3mm,
14.3mm | 7-14mm | 9mm, 10.5mm, 12mm, 15mm,
18mm |
| connection | | Internal | Internal | Internal |
| Shelf Life | | 5 years | 5 years | 5 years |
| | Principle of
Operation | Dental implant that can
be inserted on a jawbone
as a material for dental
surgery to support | Dental implant that can
be inserted on a jawbone
as a material for dental
surgery to support | Dental implant that can be
inserted on a jawbone as a
material for dental surgery to
support |
6
| Similarities | The indications for use, material, general shape design, dimension, surface treatment,
Principle of operation, shelf life and sterilization method between the CSM Submerged3-L |
|--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Implant System and the predicate devices are identical. |
| Differences | Fixture's micro-threaded part: The primary predicate, K102635 has micro threaded part on
the fixture whereas the subject device has no micro thread part. To support this
discrepancy, we chose K143022 as a reference predicate. Accordingly, we can claim the
substantially equivalence of the CSM Submerged3-L Implant System to predicate devices. |
2) Abutments
- K102635, CSM Submerged-L Implant System by CSM Implant ●
- K120043, CSM Internal-R Implant System by CSM Implant ●
- K081575, HU/HS/HG PROSTHETIC SYSTEM by Osstem Implant ●
- K112787, Karator by KJ Meditech Co, Ltd. ●
| Subject Device | Predicate Device | |
|---|---|---|
| 510(K) Number | K173141 | K102635 |
| Device Name | CSM Submerged3-L | CSM Submerged-L |
| Implant System | Implant System | |
| Manufacturer | CSM Implant | CSM Implant |
| Indications for Use | The CSM Submerged3-L Implant | |
| System is intended for use in support of | ||
| single or multiple-unit restorations and | ||
| partial or fully edentulous mandibles and | ||
| maxilla. This system is intended for | ||
| delayed loading. | CSM Implants are intended for use in | |
| support of single or multiple-unit | ||
| restorations and partial or fully | ||
| edentulous mandibles and maxilla. This | ||
| system is intended for delayed loading. | ||
| Material | Ti-6Al-4V ELI (ASTM-F136) | Ti-6Al-4V ELI (ASTM-F136) |
| Diameter | 4.02mm, 4.5mm, 5.5mm, 6.5mm | 4.02mm, 4.52mm, 5.52mm, 6.52mm |
| Length | 8.25mm, 8.75mm, 9.75mm, 10.35mm, | |
| 10.75mm, 11.75mm, 12.35mm, | ||
| 12.75mm | 8.55mm, 8.75mm, 9.25mm, 9.35mm, | |
| 10.75mm, 11.35mm, 11.75mm, | ||
| 12.75mm | ||
| Appearance | ||
| Principle Operation | Linked to fixture, this has covered the | |
| joint of fixture until gingiva recovers. | Linked to fixture, this has covered the | |
| joint of fixture until gingiva recovers. | ||
| Similarities | The indications for use, material, general shape design, dimension, surface | |
| treatment, Principle of operation, and shelf life are identical. | ||
| Differences | The diameters and lengths of the subject device are slightly different from the | |
| predicate device. However, the predicate device includes healing abutments that | ||
| meet or exceed the diameter and total height range compared to the dimensions of | ||
| the subject device. Therefore, the subject device is substantially equivalent. |
7
| Subject Device | Predicate Device | |
|---|---|---|
| 510(K) Number | K173141 | K102635 |
| Device Name | CSM Submerged3-L | CSM Submerged-L |
| Implant System | Implant System | |
| Manufacturer | CSM Implant | CSM Implant |
| Indications for Use | The CSM Submerged3-L Implant | |
| System is intended for use in support of | ||
| single or multiple-unit restorations and | ||
| partial or fully edentulous mandibles and | ||
| maxilla. This system is intended for | ||
| delayed loading. | CSM Implants are intended for use in | |
| support of single or multiple-unit | ||
| restorations and partial or fully | ||
| edentulous mandibles and maxilla. This | ||
| system is intended for delayed loading. | ||
| Material | Ti-6Al-4V ELI (ASTM-F136) | Ti-6Al-4V ELI (ASTM-F136) |
| Diameter | 4.5mm, 5.5mm, 6.5mm | 4.0mm, 4.5mm, 5.5mm, 6.5mm |
| Length | 8.0mm, 8.5mm, 9.0mm, 9.5mm, | |
| 10.5mm, 11.5mm, 12.5mm, 13.5mm | 8.8mm, 9.45mm, 9.5mm, 10.3mm, | |
| 10.45mm, 11.3mm, 11.45mm, 12.3mm | ||
| Appearance | Image: Abutment | Image: Abutment |
| Principle Operation | Abutment used to fix crown, after being | |
| engaged with fixture. | Abutment used to fix crown, after being | |
| engaged with fixture. | ||
| Similarities | The indications for use, material, general shape design, dimension, surface | |
| treatment, Principle of operation, and shelf life are identical. | ||
| Differences | The length and diameters of two devices are slightly different. However, the | |
| dimensional differences of these devices do not have any influence on the | ||
| Substantial equivalence, since it is within the legend of predicate, and the | ||
| indications, principle of operations and raw material are identical. |
| Subject Device | Predicate Device | |
| 510(K) Number | K173141 | K102635 |
| Device Name | CSM Submerged3-L | |
| Implant System | CSM Submerged-L | |
| Implant System | ||
| Manufacturer | CSM Implant | CSM Implant |
| Indications for Use | The CSM Submerged3-L Implant | |
| System is intended for use in support of | ||
| single or multiple-unit restorations and | ||
| partial or fully edentulous mandibles and | ||
| maxilla. This system is intended for | ||
| delayed loading. | CSM Implants are intended for use in | |
| support of single or multiple-unit | ||
| restorations and partial or fully | ||
| edentulous mandibles and maxilla. This | ||
| system is intended for delayed loading. | ||
| Material | Ti-6Al-4V ELI (ASTM-F136) | Ti-6Al-4V ELI (ASTM-F136) |
| Diameter | 4.0mm, 4.5mm, 5.5mm | 4.5~5.5mm |
| Length | 9.0mm, 9.4mm, 9.5mm, 10.0mm, | |
| 10.3mm,10.4mm,10.5mm,11.3mm, | ||
| 11.4mm, 11.5mm, 12.3mm, 12.5mm, | ||
| 13.3mm, 13.5mm | 15.31mm |
8
| Appearance | Image: dental abutment | Image: dental abutment |
|---|---|---|
| Angulation | 15°, 20° | 15°, 20° |
| Principle Operation | Abutment used to form right connection | |
| between crown and fixture inserted | ||
| diagonally | Abutment used to form right connection | |
| between crown and fixture inserted | ||
| diagonally | ||
| Similarities | The indications for use, material, general shape design, dimension, surface | |
| treatment, Principle of operation, and shelf life are identical. | ||
| Differences | The diameters and lengths of the subject device are slightly different from the | |
| predicate device. However, the predicate device includes Angled Abutments that | ||
| meet or exceed the diameter and total height range compared to the dimensions of | ||
| the subject Angled Abutments. Therefore, the subject device is substantially | ||
| equivalent. |
| Subject Device | Predicate Device | |
|---|---|---|
| 510(K) Number | K173141 | K102635 |
| Device Name | CSM Submerged3-L | |
| Implant System | CSM Submerged-L | |
| Implant System | ||
| Manufacturer | CSM Implant | CSM Implant |
| Indications for Use | The CSM Submerged3-L Implant | |
| System is intended for use in support of | ||
| single or multiple-unit restorations and | ||
| partial or fully edentulous mandibles and | ||
| maxilla. This system is intended for | ||
| delayed loading. | CSM Implants are intended for use in | |
| support of single or multiple-unit | ||
| restorations and partial or fully | ||
| edentulous mandibles and maxilla. This | ||
| system is intended for delayed loading. | ||
| Material | Ti-6Al-4V ELI (ASTM-F136) | Ti-6Al-4V ELI (ASTM-F136) |
| Diameter | 2.1mm, 2.33mm | 2.1mm, 2.33mm |
| Length | 8.3mm, 10.0mm | 8.6mm, 10.8mm |
| Appearance | Image: Screw | Image: Screw |
| Principle Operation | Screw used to link abutment to fixture | Screw used to link abutment to fixture |
| Similarities | The indications for use, material, general shape design, dimension, surface | |
| treatment, Principle of operation, and shelf life are identical. | ||
| Differences | The diameters and lengths of the subject device are slightly different from the | |
| predicate device. However, the predicate device includes Abutment screws that | ||
| meet or exceed the diameter and total height range compared to the dimensions of | ||
| the subject Abutment Screws. Therefore, the subject device is substantially | ||
| equivalent. |
9
| Subject Device | Predicate Device | |
|---|---|---|
| 510(K) Number | K173141 | K102635 |
| Device Name | CSM Submerged3-L | |
| Implant System | CSM Submerged-L | |
| Implant System | ||
| Manufacturer | CSM Implant | CSM Implant |
| Indications for Use | The CSM Submerged3-L Implant | |
| System is intended for use in support of | ||
| single or multiple-unit restorations and | ||
| partial or fully edentulous mandibles and | ||
| maxilla. This system is intended for | ||
| delayed loading. | CSM Implants are intended for use in | |
| support of single or multiple-unit | ||
| restorations and partial or fully | ||
| edentulous mandibles and maxilla. This | ||
| system is intended for delayed loading. | ||
| Material | Ti-6Al-4V ELI (ASTM-F136) | Ti-6A1-4V ELI (ASTM-F136) |
| Diameter | 2.83mm, 3.33mm | 2.83mm, 3.33mm |
| Length | 6.0mm, 6.5mm | 6mm, 6.5mm |
| Appearance | ||
| Principle Operation | Screw used to cover the joint of fixture | |
| to prevent foreign matter from entering. | Screw used to cover the joint of fixture | |
| to prevent foreign matter from entering. | ||
| Similarities | The indications for use, material, general shape design, dimension, surface | |
| treatment, Principle of operation, and shelf life are identical. | ||
| Differences | These two products are substantially identical. |
| Subject Device | Predicate Device | |
|---|---|---|
| 510(K) Number | K173141 | K112787 |
| Device Name | CSM Submerged3-L | |
| Implant System | Kerator | |
| Manufacturer | CSM Implant | KJ Meditech Co, Ltd. |
| Indications for Use | The CSM Submerged3-L Implant System is | |
| intended for use in support of single or | ||
| multiple-unit restorations and partial or fully | ||
| edentulous mandibles and maxilla. This | ||
| system is intended for delayed loading. | The Kerator is appropriate for use | |
| with overdentures or partial | ||
| dentures retained in whole or in | ||
| part by endosseous implants in the | ||
| mandible or maxilla. | ||
| Material | Ti-6Al-4V ELI (ASTM-F136) | Ti-6Al-4V ELI (ASTM-F136) |
| Diameter | 3.9mm | 3.86mm |
| Length | 7.15mm, 7.4mm, 7.65mm, 7.9mm, 8.65mm, | |
| 8.9mm, 9.65mm, 9.9mm, 10.65mm, 10.9mm, | ||
| 11.65mm, 11.9mm, 12.65mm, 12.9mm, | ||
| 13.65mm, 13.9mm, 14.65mm, 14.9mm, | ||
| 15.65mm, 15.9mm, 16.65mm, 16.9mm | 9mm,9.6mm | |
| Appearance | Image: CSM Submerged3-L Implant | Image: Kerator Implant |
| Principle Operation | Abutment used to link overdenture to gingiva. | Abutment used to link overdenture |
| to gingiva. |
10
| Similarities | The main similarities between these two items are indication for use, and materials. |
|---|---|
| Differences | Even though these are dimensional differences, the different sizes of two products |
| do not have any influences on the substantial equivalence, as the Indications | |
| principles and the raw materials are equivalent. |
| Subject Device | Predicate Device | |
|---|---|---|
| 510(K) Number | K173141 | K081575 |
| Device Name | CSM Submerged3-L | |
| Implant System | O-Ring Retainer Cap set | |
| (HU/HS/HG PROSTHETIC SYSTEM) | ||
| Manufacturer | CSM Implant | OSSTEM Implant |
| Indications for Use | The CSM Submerged3-L Implant | |
| System is intended for use in support of | ||
| single or multiple-unit restorations and | ||
| partial or fully edentulous mandibles and | ||
| maxilla. This system is intended for | ||
| delayed loading. | HU/HS/HG Prosthetic System is | |
| intended for use with a dental implant to | ||
| provide support for prosthetic | ||
| restorations such as crowns, bridges, or | ||
| overdentures. | ||
| Material | Ti-6A1-4V ELI (ASTM-F136) | Titanium / Silicone |
| Diameter | 5.45mm | 5.45mm |
| Length | 2.4mm | 2.35mm |
| Appearance | Image: Three stacked metal cylinders | Image: O-Ring Retainer Cap set |
| Principle Operation | Cap used to link overdenture to retainer | |
| abutment. | Cap used to link overdenture to retainer | |
| abutment. | ||
| Similarities | The main similarities of these two items are indications for use and how to function. | |
| Differences | Even though these are dimensional differences, the different sizes of two products | |
| do not have any influences on the substantial equivalence, as the indications, | ||
| principles, and the raw materials are equivalent. |
| Subject Device | Predicate Device | |
|---|---|---|
| 510(K) Number | K173141 | K112787 |
| Device Name | CSM Submerged3-L | |
| Implant System | Kerator | |
| Manufacturer | CSM Implant | KJ Meditech Co, Ltd. |
| Indications for Use | The CSM Submerged3-L Implant | |
| System is intended for use in support of | ||
| single or multiple-unit restorations and | ||
| partial or fully edentulous mandibles and | ||
| maxilla. This system is intended for | ||
| delayed loading. | The Kerator is appropriate for use with | |
| overdentures or partial dentures retained | ||
| in whole or in part by endosseous | ||
| implants in the mandible or maxilla. | ||
| Material | POLYAMIDE 6.6 | DuPont Zytel 101L NC-10 Nylon Low |
| Density Polyethelene 993 | ||
| Diameter | 4.7mm | 4.8mm |
| Length | 1.85mm, 2.06mm | 1.48mm |
| Appearance | Image: white ring | Image: yellow ring |
11
| Patient contact | No | No |
|---|---|---|
| Principle Operation | Retention cap used to connect | |
| overdenture with retainer abutment by | ||
| being located in retainer cap. | Retention cap used to connect | |
| overdenture with retainer abutment by | ||
| being located in retainer cap. | ||
| Similarities | The similarities between these two items are indication for use and the way to be | |
| placed. | ||
| Differences | The differences of these two products are material and the sizes. Since these | |
| products are no patient contact device, the difference of material doesn't influence | ||
| the substantial equivalence and since both products have similar indications, same | ||
| principle of operations, the differences of sizes do not influence the substantial | ||
| equivalence with the predicate. |
| Subject Device | Predicate Device | |
|---|---|---|
| 510(K) Number | K173141 | K120043 |
| Device Name | CSM Submerged3-L | |
| Implant System | CSM Internal-R | |
| Implant System | ||
| Manufacturer | CSM Implant | CSM Implant |
| Indications for Use | The CSM Submerged3-L Implant | |
| System is intended for use in support of | ||
| single or multiple-unit restorations and | ||
| partial or fully edentulous mandibles and | ||
| maxilla. This system is intended for | ||
| delayed loading. | The CSM Internal-R Implant System is | |
| indicated for use in partially or fully | ||
| edentulous mandibles and maxillae, in | ||
| support of single or multiple-unit | ||
| restorations including; cemented | ||
| retained, screw retained, or overdenture | ||
| restorations, and terminal or | ||
| intermediate abutment support for fixed | ||
| bridgework. This system is intended for | ||
| delayed loading. | ||
| Material | Ti-6Al-4V ELI (ASTM-F136) | Ti-6Al-4V ELI (ASTM-F136) |
| Diameter | 4.5mm, 5.5mm | 4.5mm, 5.5mm |
| Length | 12.8mm, 13.3mm, 13.8mm, 14.8mm, | |
| 15.8mm, 16.8mm | 12.8mm, 13.3mm, 13.8mm, 14.8mm, | |
| 15.8mm, 16.8mm | ||
| Appearance | Image: CSM Submerged3-L Implant | Image: CSM Internal-R Implant |
| Principle Operation | Abutment fastened to fixture for | |
| working model with torx driver | Abutment fastened to fixture for | |
| working model with torx driver | ||
| Similarities | The indications for use, material, dimension, surface treatment, Principle of | |
| operation, shelf life are identical. | ||
| Differences | The shape of two devices is different but there is no influence on the substantial | |
| equivalance because they have similar indications for use and same materials, | ||
| prinicple of operations and dimensions. |
12
Similarities
The indications for use, material, general shape design, dimension, surface treatment, connection to abutment method, application method and sterilization method between the CSM Submerged3-L Implant System and the predicate devices are similar.
Differences
Accordingly, we can claim the substantially equivalence of the CSM Submerged3-L Implant System to predicate devices.
Non-Clinical Data:
The subject device was tested to evaluate its substantial equivalence according to the following standards.
- End User Steam Sterilization Test according to ISO 17665-1:2006, -2:2009 and ANSI/AAMI ST79
- . Biocompatibility Test such as cytotoxicity according to ISO 10993-5:2009, irritation according to ISO 10993-10:2010, sensitization according to ISO 10993-10:2010, acute systemic according to ISO 10993-11:2006, and genotoxicity according to ISO 10993-3:2014.
Below tests were performed for predicate devices and leveraged for the subject device:
- Sterilization Validation Test according to ISO 11137-1,2,3 referenced in K102635.
- Fatigue Test according to ISO 14801 referenced in K102635. ●
- Accelerated Aging Test (Shelf Life Test) according to ASTM F1980-07 referenced in K102635.
The end user sterilization test was performed for the subject abutments.
The sterilization validation test was performed for the predicate, K102635 and leveraged for the subject product because the product material, sterilization site, sterilization method, SAL, sterilization parameters are exactly identical to the predicate, K102635.
The biocompatibility tests were performed on the subject device and it demonstrated the subject device is biocompatible.
The accelerated aging testing was performed for predicate device, K102635 and leveraged for the subject device because the product category, material, manufacturing process, facility, packaging material and packaging procedure are the exactly the same as the predicate, K102635.
The fatigue testing was performed for the predicate device. K102635 and leveraged for the subject device because we compared the worst-case implants and the test sample from K102635 was the worst. Therefore, it supports mechanical properties.
The results of the above tests have met the criteria of the standards, and demonstrated the substantial equivalence with the predicate device and are compliant with Guidance of "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant and Endosseous Dental Implant abutments".
13
Conclusion
The CSM Submerged3-L Implant System, subject device of this submission, constitutes a substantially equivalent medical device, meeting all the declared requirements of its intended use. This system has the same intended use and fundamental scientific technology as its predicate devices. Therefore, CSM Submerged3-L Implant System, and its predicates are substantially equivalent.