(253 days)
No
The document describes a dental implant system and does not mention any AI or ML components or capabilities.
No
The device is a dental implant system used to replace missing teeth, which is a restorative procedure rather than a therapeutic one aiming to treat a disease or condition.
No
Explanation: The device is a dental implant system used for supporting multiple-unit restorations and replacing missing teeth, not for diagnosing medical conditions. It is a therapeutic/restorative device.
No
The device description clearly states it is a dental implant system made of Titanium 6AL 4V ELI alloy, which is a physical hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Kerator system is a dental implant system designed to be surgically placed in the bone of the jaw to support dental restorations. It is a physical device used in vivo (within the body), not a test performed in vitro (outside the body).
- Intended Use: The intended use is for supporting multiple-unit restorations and overdentures/partial dentures in the mouth. This is a structural and prosthetic function, not a diagnostic one.
The description clearly indicates a surgical implant and associated components for dental restoration, which falls under the category of medical devices, but not specifically in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Kerator fixture is intended for use in partially or fully edentulous mandibles and maxillae, in support of multiple-unit restorations. The Kerator abutments are intended use with overdentures or partial dentures. Kerator AO type is compatible with Kerator fixture and the following types are compatible with the fixtures made by other manufacturers as indicated below.
| Kerator Abutment Type | Fixture Trade Name | Manufacturer | Model Name | Size(Diameter) |
|---|---|---|---|---|
| AR401 | ANYRIDGE INTERNAL IMPLANT SYSTEM | Megagen | FANIHX5010 | 5.00 Ø |
| AT301 | ASTRA TECH IMPLANT SYSTEM | ASTRA TECH AB | 24983 | 3.0 Ø |
| AT401 | ASTRA TECH IMPLANT SYSTEM | ASTRA TECH AB | 24940 | 4.0 Ø |
Product codes
DZE, NHA
Device Description
The Kerator is a dental implant system made of Titanium 6AL 4V ELI alloy intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. There are one fixture model and three abutment models in the Kerator. Among three abutment model is compatible with the Kerator fixture, and the other two abutment models are compatible with the fixtures made by other manufacturers. The implant may be used to replace one or more missing teeth. The system is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The surface of the fixture has been treated with R.B.M (Resorbable Blast Media) and the head part of the abutment has TiN coating over it. The Kerator abutment is placed into the dental implant to provide support for a prosthetic restoration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandibles and maxillae (upper or lower jaw arches)
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 Testing:
- Sterilization validating testing has been performed in accordance with ISO 11737-1 & ISO 11737-2 for gamma sterilization and ISO 17665-1 and ISO 17665-2 for steam sterilization.
- The three year of shelf life has been validated through accelerating testing.
- Chemical and SEM image analyses have been performed to verify that there is no residual after RBM treatment on the fixtures.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
510(k) Summary (K132144)
This summary of 510(K) - safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: 02/21/2014
1. Applicant / Submitter
KJ Meditech Co., Ltd. 959-21 Daechon-dong, Buk-gu, Gwang-ju, 500-470, South Korea Tel: +82-62-972-5476 Fax: +82-62-973-2809
2. Submission Contact Person
LK Consulting Group USA, Inc. 1515 E Katella Ave. Unit 2115, Anaheim, CA 92805 Priscilla Juhee Chung Phone: 714.202.5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com
3. Device
Trade Name: Kerator Common Name: Dental Implant System Classification Name: Endosseous Dental Implant System Product Code: DZE, NHA Classification regulation: 21CFR872.3640
2. Predicate Device:
Hero & IS Dental Implant System by KJ Meditech Co., Ltd. (K121047) Kerator by KJ Meditech Co., Ltd. (K112787) Locator Implant Anchor.by Zest Anchors Inc. (K994257)
3. Description:
The Kerator is a dental implant system made of Titanium 6AL 4V ELI alloy intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. There are one fixture model and three abutment models in the Kerator. Among three abutment model is compatible with
510(k) Submission.
1
the Kerator fixture, and the other two abutment models are compatible with the fixtures made by other manufacturers. The implant may be used to replace one or more missing teeth. The system is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The surface of the fixture has been treated with R.B.M (Resorbable Blast Media) and the head part of the abutment has TiN coating over it. The Kerator abutment is placed into the dental implant to provide support for a prosthetic restoration.
· Kerator implant fixtrue
- Implant Type: Bone Level Implant
- Connection Type: Internal Hexagon
- Body Design: Tapered design enables placement near impringing anatomical structures while maximizing
- Size: 4.75mm Dia. x 10mm L
• Kerator abutments
-
l) AO Type:
- Connection type: This abutment is used with the Kerator fixture(Internal H exagon).
-
Size Range: 3.87mm Dia. x 8.55 ~ 14.55mm L.
-
- AR Type:
- Connection type: This abutment is used with the Megagen AnyRidge Fixture (5.0mm Dia., Internal Hexagon)
- Size Range: 3.87mm Dia. x 7.0~13.5mm L.
-
- AT Type:
- Connection type: This abutment is used with the Astra Tech Fixture (3.0mm and 4.0mm Dia., Internal Hexagon)
- Size Range: 3.87mm Dia. x 8.5~13.7mm L.
4. Indication for use:
The Kerator fixture is intended for use in partially or fully edentulous mandibles and maxillae, in support of multiple-unit restorations. The Kerator abutments are intended use with overdentures or partial dentures. Kerator AO type is compatible with Kerator fixture and the following types are compatible with the fixtures made by other manufacturers as indicated below.
2
| Kerator
Abutment
| Type | Fixture Trade Name | Manufacturer | Model Name | Size(Diameter) |
|---|---|---|---|---|
| AR401 | ANYRIDGE | |||
| INTERNAL | ||||
| IMPLANT SYSTEM | Megagen | FANIHX5010 | 5.00 Ø | |
| AT301 | ASTRA TECH | |||
| IMPLANT SYSTEM | ASTRA TECH AB | 24983 | 3.0 Ø | |
| AT401 | ASTRA TECH | |||
| IMPLANT SYSTEM | ASTRA TECH AB | 24940 | 4.0 Ø |
5. Basis for Substantial Equivalence
The design features and sizing of the components were compared between the subject device and the predicate devices 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 other devices in design, function, material and intended use.
Non-Clinical Testing 6.
- · Sterilization validating testing has been performed in accordance with ISO 11737-1 & ISO 11737-2 for gamma sterilization and ISO 17665-1 and ISO 17665-2 for steam sterilization.
- · The three year of shelf life has been validated through accelerating testing.
- " Chemical and SEM image analyses have been performed to verify that there is no residual after RBM treatment on the fixtures.
7. Conclusion
The subject devices and the predicate devices have intended use and have the same technological characteristics. The subject and predicate implants are all made of commercially pure titanium and have the same surface treatments.
Overall, the Kerator has the following similarities to the predicate devices:
-
- has the same intended use,
-
- uses the same operating principle,
-
- incorporates the same basic design.
-
- incorporates the same material and the surface treatment.
Based on the similarities, we conclude that the Keiator is substantially equivalent to the predicate device.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures or waves, stacked on top of each other.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-Gb09 Silver Spring, MD 20993-0002
March 21, 2014
KJ Meditech Company, Limited C/O Ms. Priscilla Juhee Chung Regulatory Affairs Consultant LK Consulting Group USA. Incorporated 1515 E Katella Avenue. Unit 2115 Anaheim, CA 92805
Re: K132144
Trade/Device Name: Kerator Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: February 10, 2014 Received: February 14, 2014
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 Mav 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. 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 docs 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.
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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Erin I. Keith -S
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510{k) Number (if known) K 132144
Device Name
Kerator
Indications for Use (Describe)
The Kerator fixture is intended for use in partially or fully edentulous mandibles in support of multiple-init restorations. The Keralor abuments are intended use with overdentures. Keralor AQ type is compaible with Kerator listure and the following types are compatible with the fixtures made by other manufacturers as indicated below,
| Kerator Abutment
| Type | Fixture Trade Name | Manufacturer | Model Name | Size(Diameter) |
|---|---|---|---|---|
| AR401 | ANYRIDGE INTERNAL | |||
| IMPLANT SYSTEM | Mcgagen | FANIHX5010 | 5.00 | |
| AT301 | ASTRA TECH IMPLANT | |||
| SYSTEM | ASTRA TECH AB | 24983 | 3.00 | |
| AT401 | ASTRA TECH IMPLANT | |||
| SYSTEM | ASTRA TECH AB | 24940 | 4.00 |
Type of Use (Select one or both, as applicable)
[x] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Mary S. Runner -5 - DOS on 2014.03.20 10:25:18 -04 00
FORM FDA 3881 (9/13)
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