(355 days)
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 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the CSM Submerged3-L Implant System:
This document is a 510(k) Premarket Notification summary for a dental implant system. The primary goal of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This process typically relies heavily on bench testing and comparison of technological characteristics rather than extensive clinical efficacy studies in the way you might see for novel pharmaceuticals or advanced AI diagnostics.
Therefore, many of the questions you've asked (e.g., sample size for training/test sets, number of experts for ground truth, MRMC studies, standalone algorithm performance, data provenance) are not applicable to this type of medical device submission. These questions are typically relevant for AI/ML-based diagnostic devices or devices where human interpretation of data is a primary function.
This submission focuses on demonstrating safety and effectiveness through:
- Comparison to predicate devices: Showing that the new device has similar technological characteristics and indications for use as devices already on the market.
- Non-clinical (bench) testing: Performing specific tests to ensure the device meets established performance standards.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list "acceptance criteria" in a quantitative, pass/fail manner for the device performance in the way an AI/ML study would (e.g., "accuracy > 90%"). Instead, the acceptance criteria are implicit in the compliance with recognized standards and the demonstration of substantial equivalence to predicate devices. The "reported device performance" is essentially the statement that the device met these standards and is substantially equivalent.
| Acceptance Criteria (Implicit) | Reported Device Performance (as stated in submission) |
|---|---|
| Material Composition: Conformance to ASTM Standard F-136 (Ti-6Al-4V ELI) and use of POLYAMIDE 6.6. | "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." (Page 4&5) "Ti-6Al-4V ELI (ASTM-F136)" and "POLYAMIDE 6.6" are listed for individual components, aligning with predicates. (Pages 5-11) |
| Sterilization Efficacy (Non-sterile components): Ability to be sterilized by end-user according to ISO 17665-1:2006, -2:2009 and ANSI/AAMI ST79. | "The end user sterilization test was performed for the subject abutments." "The results of the above tests have met the criteria of the standards..." (Page 12) |
| Biocompatibility: Conformance to ISO 10993 series (cytotoxicity, irritation, sensitization, acute systemic, genotoxicity). | "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." "The biocompatibility tests were performed on the subject device and it demonstrated the subject device is biocompatible." "The results of the above tests have met the criteria of the standards..." (Page 12) |
| Sterilization Efficacy (Pre-sterilized components): Conformance to ISO 11137-1,2,3 for sterilization validation. | "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." (Page 12) |
| Fatigue Strength: Conformance to ISO 14801. | "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..." (Page 12) |
| Shelf Life/Aging: Conformance to ASTM F1980-07. | "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 results of the above tests have met the criteria of the standards..." (Page 12) |
| Substantial Equivalence: Similar intended use, fundamental scientific technology, and performance parameters to predicate devices. | The entire submission argues for this, concluding: "The CSM Submerged3-L Implant System... 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." (Page 13) |
Study Details
As mentioned, many of the requested fields are not applicable to a 510(k) submission for a non-AI/ML dental implant system.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This device is an implant and its components, not an AI/ML diagnostic system. The "testing" involves bench testing to international standards (e.g., ISO, ASTM) and comparison of physical characteristics to predicate devices. There is no "test set" in the context of imaging or patient data. Data provenance (country of origin, retrospective/prospective) is also not relevant here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. There is no "ground truth" established by experts in this context. Device performance is assessed against engineering standards and material specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No expert adjudication is involved.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is not an AI/ML-assisted device, nor is it a diagnostic tool that involves human "readers."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. There is no algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable. The "ground truth" here is the adherence to engineering specifications, material standards (e.g., ASTM F-136), and performance criteria outlined in international standards (e.g., ISO 17665, ISO 10993, ISO 14801, ASTM F1980-07).
8. The sample size for the training set
- Not Applicable. There is no training set for this type of device.
9. How the ground truth for the training set was established
- Not Applicable. There is no training set or associated ground truth.
Summary of the "Study" that Proves the Device Meets Acceptance Criteria:
The "study" consists of a combination of direct non-clinical testing on the subject device and leveraging data from legally marketed predicate devices.
-
Direct Testing on Subject Device:
- End User Steam Sterilization Test: Performed on the abutments according to ISO 17665-1:2006, -2:2009 and ANSI/AAMI ST79.
- Biocompatibility Tests: Performed on the subject device according to various parts of ISO 10993 (cytotoxicity, irritation, sensitization, acute systemic, genotoxicity).
- Results: All these tests demonstrated that the subject device met the criteria of the respective standards.
-
Leveraged Testing from Predicate Device (K102635):
- Sterilization Validation Test (ISO 11137-1,2,3): Data from the predicate K102635 was leveraged because the subject product's material, sterilization site, method, SAL, and parameters are identical.
- Fatigue Test (ISO 14801): Data from the predicate K102635 was leveraged. The applicant specifically states that the worst-case implants from the predicate's testing encompassed the subject device's mechanical properties.
- Accelerated Aging Test (Shelf Life, ASTM F1980-07): Data from the predicate K102635 was leveraged due to identical product category, material, manufacturing process, facility, packaging material, and packaging procedure.
- Results: The leveraged predicate data, combined with the direct testing, collectively demonstrate that the CSM Submerged3-L Implant System meets the required performance and safety standards, thus establishing its substantial equivalence.
In essence, the "study" is a comprehensive engineering and material science evaluation, rather than a clinical trial or an AI performance study.
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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
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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
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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)
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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.
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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.
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Summary of Technological Characteristics
1) Fixtures
| 1) Fixtures | ||||
|---|---|---|---|---|
| Subject Device | Primary Predicate | Reference Predicate | ||
| 510(K) Number | K173141 | K102635 | K143022 | |
| Device Name | CSM Submerged3-LImplant System | CSM Submerged-LImplant System | BioHorizons Tapered InternalImplants | |
| Manufacturer | CSM Implant | CSM Implant | BioHorizonsImplant Systems, Inc. | |
| Indications for Use | The CSM Submerged3-LImplant System isintended for use insupport of single ormultiple-unit restorationsand partial or fullyedentulous mandiblesand maxilla. This systemis intended for delayedloading. | CSM Implants areintended for use insupport of single ormultiple-unit restorationsand partial or fullyedentulous mandiblesand maxilla. This systemis intended for delayedloading. | Bio Horizons Tapered InternalImplants are intended for use inthe mandible or maxilla as anartificial root structure for singletooth replacement or for fixedbridgework and dental retention.Bio Horizons Tapered InternalImplants may be restoredimmediatelyI) with a temporary prosthesisthat is not infunctional occlusion, or2) when splinted together formultiple tooth replacement, orwhen stabilized with anoverdenture supported bymultiple 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(ResorbableBlasting Media) + Laser | RBM(ResorbableBlasting Media) + Laser | Implant- RBTCollar- 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 ofOperation | Dental implant that canbe inserted on a jawboneas a material for dentalsurgery to support | Dental implant that canbe inserted on a jawboneas a material for dentalsurgery to support | Dental implant that can beinserted on a jawbone as amaterial for dental surgery tosupport |
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| 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 onthe fixture whereas the subject device has no micro thread part. To support thisdiscrepancy, we chose K143022 as a reference predicate. Accordingly, we can claim thesubstantially 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 ImplantSystem is intended for use in support ofsingle or multiple-unit restorations andpartial or fully edentulous mandibles andmaxilla. This system is intended fordelayed loading. | CSM Implants are intended for use insupport of single or multiple-unitrestorations and partial or fullyedentulous mandibles and maxilla. Thissystem 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 thejoint of fixture until gingiva recovers. | Linked to fixture, this has covered thejoint of fixture until gingiva recovers. |
| Similarities | The indications for use, material, general shape design, dimension, surfacetreatment, Principle of operation, and shelf life are identical. | |
| Differences | The diameters and lengths of the subject device are slightly different from thepredicate device. However, the predicate device includes healing abutments thatmeet or exceed the diameter and total height range compared to the dimensions ofthe subject device. Therefore, the subject device is substantially equivalent. |
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| 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 ImplantSystem is intended for use in support ofsingle or multiple-unit restorations andpartial or fully edentulous mandibles andmaxilla. This system is intended fordelayed loading. | CSM Implants are intended for use insupport of single or multiple-unitrestorations and partial or fullyedentulous mandibles and maxilla. Thissystem 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 beingengaged with fixture. | Abutment used to fix crown, after beingengaged with fixture. |
| Similarities | The indications for use, material, general shape design, dimension, surfacetreatment, Principle of operation, and shelf life are identical. | |
| Differences | The length and diameters of two devices are slightly different. However, thedimensional differences of these devices do not have any influence on theSubstantial equivalence, since it is within the legend of predicate, and theindications, principle of operations and raw material are identical. |
| Subject Device | Predicate Device | |
| 510(K) Number | K173141 | K102635 |
| Device Name | CSM Submerged3-LImplant System | CSM Submerged-LImplant System |
| Manufacturer | CSM Implant | CSM Implant |
| Indications for Use | The CSM Submerged3-L ImplantSystem is intended for use in support ofsingle or multiple-unit restorations andpartial or fully edentulous mandibles andmaxilla. This system is intended fordelayed loading. | CSM Implants are intended for use insupport of single or multiple-unitrestorations and partial or fullyedentulous mandibles and maxilla. Thissystem 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 |
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| Appearance | Image: dental abutment | Image: dental abutment |
|---|---|---|
| Angulation | 15°, 20° | 15°, 20° |
| Principle Operation | Abutment used to form right connectionbetween crown and fixture inserteddiagonally | Abutment used to form right connectionbetween crown and fixture inserteddiagonally |
| Similarities | The indications for use, material, general shape design, dimension, surfacetreatment, Principle of operation, and shelf life are identical. | |
| Differences | The diameters and lengths of the subject device are slightly different from thepredicate device. However, the predicate device includes Angled Abutments thatmeet or exceed the diameter and total height range compared to the dimensions ofthe subject Angled Abutments. Therefore, the subject device is substantiallyequivalent. |
| Subject Device | Predicate Device | |
|---|---|---|
| 510(K) Number | K173141 | K102635 |
| Device Name | CSM Submerged3-LImplant System | CSM Submerged-LImplant System |
| Manufacturer | CSM Implant | CSM Implant |
| Indications for Use | The CSM Submerged3-L ImplantSystem is intended for use in support ofsingle or multiple-unit restorations andpartial or fully edentulous mandibles andmaxilla. This system is intended fordelayed loading. | CSM Implants are intended for use insupport of single or multiple-unitrestorations and partial or fullyedentulous mandibles and maxilla. Thissystem 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, surfacetreatment, Principle of operation, and shelf life are identical. | |
| Differences | The diameters and lengths of the subject device are slightly different from thepredicate device. However, the predicate device includes Abutment screws thatmeet or exceed the diameter and total height range compared to the dimensions ofthe subject Abutment Screws. Therefore, the subject device is substantiallyequivalent. |
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| Subject Device | Predicate Device | |
|---|---|---|
| 510(K) Number | K173141 | K102635 |
| Device Name | CSM Submerged3-LImplant System | CSM Submerged-LImplant System |
| Manufacturer | CSM Implant | CSM Implant |
| Indications for Use | The CSM Submerged3-L ImplantSystem is intended for use in support ofsingle or multiple-unit restorations andpartial or fully edentulous mandibles andmaxilla. This system is intended fordelayed loading. | CSM Implants are intended for use insupport of single or multiple-unitrestorations and partial or fullyedentulous mandibles and maxilla. Thissystem 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 fixtureto prevent foreign matter from entering. | Screw used to cover the joint of fixtureto prevent foreign matter from entering. |
| Similarities | The indications for use, material, general shape design, dimension, surfacetreatment, 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-LImplant System | Kerator |
| Manufacturer | CSM Implant | KJ Meditech Co, Ltd. |
| Indications for Use | The CSM Submerged3-L Implant System isintended for use in support of single ormultiple-unit restorations and partial or fullyedentulous mandibles and maxilla. Thissystem is intended for delayed loading. | The Kerator is appropriate for usewith overdentures or partialdentures retained in whole or inpart by endosseous implants in themandible 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 overdentureto gingiva. |
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| 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 productsdo not have any influences on the substantial equivalence, as the Indicationsprinciples and the raw materials are equivalent. |
| Subject Device | Predicate Device | |
|---|---|---|
| 510(K) Number | K173141 | K081575 |
| Device Name | CSM Submerged3-LImplant System | O-Ring Retainer Cap set(HU/HS/HG PROSTHETIC SYSTEM) |
| Manufacturer | CSM Implant | OSSTEM Implant |
| Indications for Use | The CSM Submerged3-L ImplantSystem is intended for use in support ofsingle or multiple-unit restorations andpartial or fully edentulous mandibles andmaxilla. This system is intended fordelayed loading. | HU/HS/HG Prosthetic System isintended for use with a dental implant toprovide support for prostheticrestorations such as crowns, bridges, oroverdentures. |
| 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 retainerabutment. | Cap used to link overdenture to retainerabutment. |
| 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 productsdo 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-LImplant System | Kerator |
| Manufacturer | CSM Implant | KJ Meditech Co, Ltd. |
| Indications for Use | The CSM Submerged3-L ImplantSystem is intended for use in support ofsingle or multiple-unit restorations andpartial or fully edentulous mandibles andmaxilla. This system is intended fordelayed loading. | The Kerator is appropriate for use withoverdentures or partial dentures retainedin whole or in part by endosseousimplants in the mandible or maxilla. |
| Material | POLYAMIDE 6.6 | DuPont Zytel 101L NC-10 Nylon LowDensity Polyethelene 993 |
| Diameter | 4.7mm | 4.8mm |
| Length | 1.85mm, 2.06mm | 1.48mm |
| Appearance | Image: white ring | Image: yellow ring |
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| Patient contact | No | No |
|---|---|---|
| Principle Operation | Retention cap used to connectoverdenture with retainer abutment bybeing located in retainer cap. | Retention cap used to connectoverdenture with retainer abutment bybeing located in retainer cap. |
| Similarities | The similarities between these two items are indication for use and the way to beplaced. | |
| Differences | The differences of these two products are material and the sizes. Since theseproducts are no patient contact device, the difference of material doesn't influencethe substantial equivalence and since both products have similar indications, sameprinciple of operations, the differences of sizes do not influence the substantialequivalence with the predicate. |
| Subject Device | Predicate Device | |
|---|---|---|
| 510(K) Number | K173141 | K120043 |
| Device Name | CSM Submerged3-LImplant System | CSM Internal-RImplant System |
| Manufacturer | CSM Implant | CSM Implant |
| Indications for Use | The CSM Submerged3-L ImplantSystem is intended for use in support ofsingle or multiple-unit restorations andpartial or fully edentulous mandibles andmaxilla. This system is intended fordelayed loading. | The CSM Internal-R Implant System isindicated for use in partially or fullyedentulous mandibles and maxillae, insupport of single or multiple-unitrestorations including; cementedretained, screw retained, or overdenturerestorations, and terminal orintermediate abutment support for fixedbridgework. This system is intended fordelayed 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 forworking model with torx driver | Abutment fastened to fixture forworking model with torx driver |
| Similarities | The indications for use, material, dimension, surface treatment, Principle ofoperation, shelf life are identical. | |
| Differences | The shape of two devices is different but there is no influence on the substantialequivalance because they have similar indications for use and same materials,prinicple of operations and dimensions. |
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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".
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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.
§ 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.