(317 days)
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.
The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The Kerator is made from Titanium grade Ti-6AI-4V ELI (meets ASTM Standard F-136) and compatible with several fixtures made by other manufactures.
Here's an analysis of the provided 510(k) summary, focusing on acceptance criteria and supporting studies:
Assessment of Acceptance Criteria and Study Details for Kerator
Based on the provided 510(k) summary for the "Kerator" device (K112787), the primary acceptance criteria and supporting studies are focused on demonstrating substantial equivalence to predicate devices, rather than establishing novel safety and effectiveness through clinical trials with specific performance metrics. This is typical for Class II medical devices seeking 510(k) clearance.
The summary emphasizes design, material, function, and intended use equivalence. The key non-clinical tests performed relate to the physical characteristics and functional compatibility of the device.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of a 510(k) for an abutment, the "acceptance criteria" are predominantly related to matching the design, materials, and functional characteristics of the predicate device, or meeting established engineering standards for such components. The performance is assessed against these equivalences.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Design and Sizing Compatibility (Geometric Equivalence) | • Reverse Engineering Analysis Conducted: Verified that Kerator has the "same sizes and the tolerance" as the predicate device and other marketed compatible fixtures. This implies the new device fits and functions mechanically like existing, cleared devices. |
| Material Composition Equivalence | • Titanium 6Al 4V ELI alloy ASTM F136: Same material as the predicate device's abutment. • DuPont Zytel 101L NC-10 Nylon / Low Density Polyethylene 993: Same materials as the predicate device's male socket. |
| Functional Equivalence (Retention Strength) | • Retention Test Carried Out: Confirmed the ability of the abutments to "resist pullout from the male cap / male housing assemblies." While no specific numerical acceptance threshold is provided in this summary, the implication is that the retention is adequate and comparable to the predicate. |
| Intended Use Equivalence | • Indicated for the "same intended uses" as predicate devices: "use with overdentures or partial dentures retained in whole or in part by endosseous implants in the mandible or maxilla." |
| Surface Treatment Equivalence | • TiN coating only for the head part of the abutment: Same as predicate. |
| Recommended Sterilization Method Equivalence | • Autoclave: Same as predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in terms of a number of physical units tested. The documentation mentions that a "reverse engineering analysis was conducted" and "the retention test has been carried out." These imply a limited number of samples were tested to demonstrate equivalence, but the precise count is not provided.
- Data Provenance: The studies are non-clinical, involving laboratory testing of the device itself.
- Country of Origin: The manufacturer is in South Korea (KJ Meditech Co., Ltd.), so the tests were likely conducted in South Korea or by a contracted lab.
- Retrospective or Prospective: These non-clinical tests were conducted prospectively as part of the 510(k) submission process to assess the newly manufactured Kerator devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
N/A. This is a non-clinical 510(k) for an implant abutment. There is no ground truth, expert consensus, or human interpretation involved in the engineering performance tests (reverse engineering for size/tolerance, or retention strength). The "ground truth" is established by direct physical measurement and engineering principles compared against established specifications of the predicate devices.
4. Adjudication Method for the Test Set
N/A. As mentioned above, there's no human interpretation or ground truth to adjudicate. The "adjudication" is essentially the comparison of physical measurements and test results against the specifications of the predicate device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. These studies are typically conducted for AI-driven diagnostic or medical image analysis devices to evaluate how human performance (e.g., diagnostic accuracy) is affected by AI assistance. The Kerator is a physical dental implant abutment, not a diagnostic or AI-enabled device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No. This is N/A. The Kerator is a physical medical device (an abutment), not an algorithm or software. Therefore, the concept of "standalone algorithm performance" is not applicable.
7. The Type of Ground Truth Used
The "ground truth" in this context is the engineering specifications and demonstrated performance characteristics of the legally marketed predicate devices.
- For design and sizing, the ground truth is the established dimensions and tolerances of the predicate devices and compatible fixtures.
- For material equivalence, the ground truth is the specified ASTM standards and material compositions of the predicate devices.
- For retention performance, the ground truth is the expected or established retention ability of commercially available, similar abutment systems, against which the Kerator's performance is implicitly (or explicitly, if thresholds were defined internally) compared.
8. The Sample Size for the Training Set
N/A. This is a physical device, not an AI or machine learning model. There is no "training set."
9. How the Ground Truth for the Training Set Was Established
N/A. There is no training set or ground truth for a training set for this type of device.
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510(k) Summary (KI12787)
This summary of 510(K) - safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: 08/06/2012
-
- Submitter
| Submitter | |
|---|---|
| Name | KJ Meditech Co., Ltd. |
| Address | 959-21 Daechon-dong, Buk-gu, Gwang-ju, 500-470, SouthKorea |
| Phone | +82-62-972-5476 |
| Fax | +82-62-973-2809 |
| Contact | Huykki Moon, CEO |
2. U.S Agent/Contact Person
LK Consulting Group 951 Starbuck St. Unit J, Fullerton, CA 92833 Priscilla Chung Phone: 714-869-3080 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com
- Device
Trade Name: Kerator Common Name: Abutment for Endosseous Implant Classification Name: Endosseous dental implant abutment Product Code: NHA Classification regulation: 21CFR872.3630
-
- Predicate Device:
Locator Implant Anchor by Zest Anchors, Inc. (K994257) Branemark System 3.3mm Fixture by NOBELPHARMA USA, INC.(K944683) Branemark System 4.00 mm Fixture by NOBELPHARMA USA, INC.(K925764) Branemark System 5.0 X 14mm Fixture by NOBELPHARMA USA, INC.(K925761) Astratech Implant System by ASTRA TECH AB (K091239) Replace Tiunite Endosseous Implant by NOBEL BIOCARE UAS INC (K023113) 4.5.* 6.0mm Dental Implant and 6.0*6.0 mm Dental Implant by BICON, INC.( K050712) Bicon Dental Implant System 3.0mm Bicon Dental Implant (K101849)
- Predicate Device:
510(k) Submission.
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Paragon Implant System by CORE-VENT BIO-ENGINEERING, INC. (K953101) ITI Dental Implant System by INSTITUT STRAUMANN AG (K033984)
- Description:
The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The Kerator is made from Titanium grade Ti-6AI-4V ELI (meets ASTM Standard F-136) and compatible with several fixtures made by other manufactures.
6. Indication for use:
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.
| Kerator Model No. | Fixture Description | Manufacturer |
|---|---|---|
| B331 - B337 | Branemark 3.3 Type | |
| B401 - B407 | Branemark 4.0 Type | NOBELPHARMA USA, INC. |
| B501 - B507 | Branemark 5.0 Type | |
| AS351 - AS357 | Astra3.5 Type | |
| AS401 - AS407 | ASTRA TECH AB | |
| G400 - G406 | Astra 4.0 Type | |
| SRS350 - SRS356 | Replace 3.5 Type | |
| SRS450 - SRS457 | Replace 4.3 Type | Nobel Biocare USA, Inc. |
| SRS500 - SRS506 | Replace 5.0 Type | |
| BC201 - BC207 | Bicon 2.0(well) Type | |
| BC301 - BC307 | Bicon 3.0(well) Type | BICON, INC. |
| PA350 - PA356 | Paragon 3.5 Type | CORE-VENT BIO- |
| PA450 - PA456 | Paragon 4.5 Type | ENGINEERING, INC. |
| T401 - T407 | ITI 4.0 Type | INSTITUT STRAUMANN AG |
The Kerator is compatible with the following fixtures.
-
- Basis for Substantial Equivalence
The Kerator is substantially equivalent to previously marketed device, Locator Implant Anchor (K994257) manufactured by Zest Anchors Inc. The design features and sizing of the components were also compared and the Kerator found to be substantially the same as these systems. It is manufactured from the same FDA recognized materials and is indicated for the same intended uses as these systems. There are no significant differences between the Kerator and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use.
- Basis for Substantial Equivalence
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| Item | Subject Device | Predicate Device |
|---|---|---|
| 510(K) Number | N / A | K994257 |
| Device Name | Kerator | Locator Implant Anchor |
| Manufacturer | KJ Meditech Co., Ltd. | Zest Anchors Inc. |
| Product Code | NHA | NHA |
| Indications for Use | The Kerator is appropriate for usewith overdentures or partialdentures retained in whole or inpart by endosseous implants in themandible or maxilla | The Locator Implant Anchorabutment for endosseous dentalimplants is appropriate for usewith overdentures or partialdentures retained in whole or inpart by endosseous implants inthe mandible or maxilla |
| PerformanceCharacteristics | The Kerator is an abutment whichis placed into dental implant toprovide support for a prostheticrestoration. | The Locator Implant Anchor is anabutment which is placed intodental implant to provide supportfor a prosthetic restoration. |
| Material(Abutment) | Titanium 6Al 4V ELI alloy ASTMF136 | Titanium 6Al 4V ELI alloyASTM F136 |
| Material(Male Socket) | DuPont Zytel 101L NC-10 NylonLow Density Polyethylene 993 | DuPont Zytel 101L NC-10 NylonLow Density Polyethylene 993 |
| Surface Treatment | TiN coating only for the head partof the abutment. | TiN coating only for the head partof the abutment |
| RecommendedSterilization Method | Autoclave | Autoclave |
8. Non-Clinical Testing
- The Kerator is compatible with several fixtures made by other manufactures. In order to claim the compatibility with those fixtures, the reverse engineering analysis was conducted to verify if Kertor has the same sizes and the tolerance as the predicate device which is already being marketed as the compatible ones for them. According to the test results, we conclude that they have the same size and tolerance as well as the design.
- The retention test has been carried out to confirm the ability of the abutments to resist pullout from the male cap / male housing assemblies.
9. Conclusion
Based on the information provided in this premarket notification, KJ Meditech Co., Ltd. concludes that Kerator is substantially equivalent to the predicate device as described herein.
510(k) Submission.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
AUG 8 2012
KJ MEDITECH Company, Limited C/O Ms. Priscilla Chung LK Consulting Group 951 Starbuck Street, Unit J Fullerton, California 92833
Re: K112787 Trade/Device Name: Kerator Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: July 26, 2012 Received: July 31, 2012
Dear Ms. 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 mendments, 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 approvisions of the Act. The general controls provisions of the Act include controls provibroils of annual registration, listing of devices, good manufacturing proctice, lequitenents for annual registers 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 (1 wirt), it may of be boyer of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2- Ms. Chung
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Wh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K112787
Device Name: Kerator
Indications For Use:
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.
The Kerator is compatible with the following fixtures.
| Kerator Model No. | Fixture Description | Manufacturer |
|---|---|---|
| B331 - B337 | Branemark 3.3 Type | |
| B401 - B407 | Branemark 4.0 Type | NOBELPHARMA USA, INC. |
| B501 - B507 | Branemark 5.0 Type | |
| AS351 - AS357 | Astra3.5 Type | |
| AS401 - AS407 | ASTRA TECH AB | |
| G400 - G406 | Astra 4.0 Type | |
| SRS350 - SRS356 | Replace 3.5 Type | |
| SRS450 - SRS457 | Replace 4.3 Type | Nobel Biocare USA, Inc. |
| SRS500 - SRS506 | Replace 5.0 Type | |
| BC201 - BC207 | Bicon 2.0 Type | |
| BC301 - BC307 | Bicon 3.0 Type | BICON, INC. |
| PA350 - PA356 | Paragon 3.5 Type | CORE-VENT BIO-ENGINEERING, INC. |
| PA450 - PA456 | Paragon 4.5 Type | |
| T401 - T407 | ITI 4.0 Type | INSTITUT STRAUMANN AG |
Prescription Use V (Per 21 CFR 801 Subpart D)
AND
Over-The Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | Susan Raver |
|---|---|
| (Division Sign-Off) | Division of Anesthesiology, General HospitalInfection Control, Dental Devices |
510(k) Number:
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)