(317 days)
Not Found
No
The summary describes a mechanical dental abutment and does not mention any AI/ML components or functionalities.
No
The device is an abutment for dental implants, providing support for prosthetic restorations, not directly treating a disease or condition.
No
Explanation: The device, 'Kerator', is described as an abutment placed into a dental implant to support a prosthetic restoration. Its purpose is mechanical support and retention, not the identification or diagnosis of a disease or condition.
No
The device description explicitly states the device is made from Titanium and is an abutment placed into a dental implant, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as an abutment for dental implants used to support dentures. This is a mechanical device used within the body for structural support.
- Device Description: The description confirms it's an abutment made of titanium, placed into a dental implant. This aligns with a surgical/prosthetic device, not a diagnostic one.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to provide information about a disease or condition.
- Performance Studies: The performance studies focus on mechanical properties like compatibility and retention, which are relevant to a structural implant component, not a diagnostic test.
IVD devices are specifically designed to perform tests on samples taken from the body to aid in diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandible or 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)
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K994257, K944683, K925764, K925761, K091239, K023113, K050712, K101849, K953101, K033984
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)
0
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, South |
| Korea | |
| 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.
1
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
2
| 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 use | |
| with overdentures or partial | ||
| dentures retained in whole or in | ||
| part by endosseous implants in the | ||
| mandible or maxilla | The Locator Implant Anchor | |
| abutment for endosseous dental | ||
| implants is appropriate for use | ||
| with overdentures or partial | ||
| dentures retained in whole or in | ||
| part by endosseous implants in | ||
| the mandible or maxilla | ||
| Performance | ||
| Characteristics | The Kerator is an abutment which | |
| is placed into dental implant to | ||
| provide support for a prosthetic | ||
| restoration. | The Locator Implant Anchor is an | |
| abutment which is placed into | ||
| dental implant to provide support | ||
| for a prosthetic restoration. | ||
| Material | ||
| (Abutment) | Titanium 6Al 4V ELI alloy ASTM | |
| F136 | Titanium 6Al 4V ELI alloy | |
| ASTM F136 | ||
| Material | ||
| (Male Socket) | DuPont Zytel 101L NC-10 Nylon | |
| Low Density Polyethylene 993 | DuPont Zytel 101L NC-10 Nylon | |
| Low Density Polyethylene 993 | ||
| Surface Treatment | TiN coating only for the head part | |
| of the abutment. | TiN coating only for the head part | |
| of the abutment | ||
| Recommended | ||
| Sterilization 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.
3
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.
4
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
5
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 Hospital |
| Infection Control, Dental Devices |
510(k) Number: