(345 days)
No
The summary describes a standard dental implant system and does not mention any AI or ML components or functionalities.
Yes.
The device is a dental implant system intended to replace missing teeth, which is a therapeutic purpose.
No
The device description and intended use indicate it is an implant system used for replacing missing teeth, not for diagnosing conditions. The performance studies refer to non-clinical testing for safety and equivalence, not diagnostic accuracy.
No
The device description clearly states it is a dental implant system made of CP Ti Gr 4, which is a physical hardware component intended for surgical placement. The performance studies also focus on hardware-related testing like sterilization, surface characteristics, fatigue, and biocompatibility.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device surgically placed in the bone to support dental restorations. This is a surgical implant, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details the material, placement, and surface treatment of a dental implant. This aligns with a surgical device, not an IVD.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring analytes
Therefore, the AR N SLA Type Implant System is a surgical dental implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
AR N SLA Type Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. AR_N SLA Type Implant System is for two stage surgical procedures. It is intended for delayed load.
Product codes
DZE
Device Description
The AR_N SLA Type Implant System is a dental implant system made of CP Ti Gr 4 per ASTM F67, intended to be surgically placed in the bone of the upper or lower jaw arches for loading affer a conventional healing period. The implants may be used to replace one or more missing teeth. The surface of the implants has been treated with SLA(Sandblasted with Large-grit and Acid-etching). The AR N SLA Type Implant System is offered in the following sizes. Subject implant bodies are to be used only with all abutments cleared in the primary predicate submission, and the cover screw and abutment screw to be used are the same as cleared in the primary predicate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
edentulous mandibles and maxillae
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 subject device was tested to evaluate its performance and demonstrate substantial equivalence as below.
- Sterilization Validation testing for sterile devices (fixtures) has been performed in accordance ● with ISO 11137, ISO 11737-1& ISO 11737-2 for gamma sterilization
- . Surface Characteristics Test Report - Chemical and SEM image analyses have been performed to verify that there is no residual after SLA treatment on the fixtures.
- Fatigue testing of the predicate device has been performed in accordance with ISO 14801:2007. Since the raw materials, manufacturing process except surface modification method, packaging materials and worst-case geometries are identical between the subject and predicate devices, the test reports can be leveraged for the subject device. The difference in surface treatment is not expected to impact fatigue performance.
- Biocompatibility testing per ISO 10993-1, ISO 10993-5:2009, ISO 10993-10:2010
- . Pyrogenicity testing - All recommended information for an implanted device related to pyrogenicity is provided in accordance with a reference to the FDA Guidance. "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile."
- LAL bacterial endotoxin testing per USP 41 , rev. 05/2018, USP 41 , rev. 05/2018, ANSI/AAMI ST72:2011
- Shelf Life testing has been conducted on the predicate devices (K171297) in accordance with ISO 11607, ISO11137, ASTM F1980. Since the raw materials, manufacturing process, sterilization method, packaging materials and methods are identical between the subject and predicate devices, and surface treatment is not expected to impact shelf life, the test reports can be leveraged for the subject device. To support the accelerated aging shelf life, real aging test has been initiated.
The results of the non-clinical testing demonstrate that the subject device is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
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February 21, 2020
Biotem Co., Ltd. % Joyce Bang-Kwun Consultant Provision Consulting Group Inc. 3350 Shelby St. Suite 200 Ontario, California 91764
Re: K190641
Trade/Device Name: AR N SLA Type Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: January 21, 2020 Received: January 27, 2020
Dear Joyce Bang-Kwun:
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.
1
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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190641
Device Name AR_N SLA Type Implant System
Indications for Use (Describe)
AR N SLA Type Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. AR_N SLA Type Implant System is for two stage surgical procedures. It is intended for delayed load.
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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3
510(K) Summary (K190641)
Submitter:
Hong Koo Yeo Biotem Co., Ltd. 422 Sasang-ro, Sasang-gu, Busan , 46925 Korea Tel : +82-70-8220-4934 Fax : +82-51-908-8257
Official Correspondent/ US Agent:
Joyce Bang-Kwon Provision Consulting Group, Inc. 100 N Barranca St. Ste 700 West Covina, CA 91791 Phone: +1-909-493-3276 Revision date: Feb 18, 2020
Device Information:
- · Device Name: AR N SLA Type Implant System
- · Classification Name: Endosseous Dental Implant
- · Common Name: Endosseous Dental Implant
- · Classification: Class II
- · Product Code: DZE
- · Regulation number: 21 CFR 872.3640
Primary Predicate
- · AR N Type Implant System (K171297)
Reference devices
Indication for use
AR N SLA Type Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. AR N SLA Type Implant System is for two stage surgical procedures. It is intended for delayed loading.
Device Description
The AR_N SLA Type Implant System is a dental implant system made of CP Ti Gr 4 per ASTM F67, intended to be surgically placed in the bone of the upper or lower jaw arches for loading affer a conventional healing period. The implants may be used to replace one or more missing teeth. The surface of the implants has been treated with SLA(Sandblasted with Large-grit and Acid-etching). The AR N SLA Type Implant System is offered in the following sizes. Subject implant bodies are to be used only with all abutments cleared in the primary predicate submission, and the cover screw and abutment screw to be used are the same as cleared in the primary predicate.
4
Substantial Equivalence Comparison Chart (fixtures)
5
| Design | Internal Hex Submerged
Macro thread | Internal Hex Submerged
Macro thread | Internal Hex Submerged
Macro thread | Straight, Threaded |
|-------------------------------|----------------------------------------|----------------------------------------|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material | CP Ti Gr 4
ASTM F67 | CP Ti Gr 4
ASTM F67 | CP Ti Gr 4
ASTM F67 | CP Ti |
| Fixture Body
Diameter (mm) | 3.7, 4.2, 4.6, 5.1, 6.0 | 3.7, 4.2, 4.6, 5.1 | 3.7, 4.2, 4.6, 5.1, 6.0 | 3.75, 5.0, 6.0 |
| Fixture
Length (mm) | 7.5, 8.5, 10, 11.5, 13, 15 | 7.5, 8.5, 10, 11.5, 13, 15 | 7, 7.5, 8, 9.5, 10, 11.5, 12, 14 | $ \varnothing $ 3.75: 7, 8.5, 10, 11.5, 13, 15,
18, 20
$ \varnothing $ 5.0: 6, 7, 8.5, 10, 11.5, 13, 15,
18
$ \varnothing $ 6.0: 7, 8.5, 10, 11.5, 13, 15 |
| Surface treatment | SLA | RBM | SLA | Grit blasted
Machine collar versions
available |
6
Comparison Analysis
Similarities:
The subject device (K190641) and the primary predicate (K171297) both have the same principle of operation, fundamental technology, intended use, indications for use, packaging material/process, product code, connection type, method of sterilization, material (titanium), and the dimensions except 6.0 mm of diameter.
Differences:
One difference between the subject device and the primary predicate device is the surface treatment. The surface treatment method of the predicate fixture is RBM (Resorbable Blasting Media) whereas the surface treatment method of the subject device is SLA (Sandblasted with Large-grit and Acid-etching). To support this discrepancy, K132242 was added as a reference device which was treated with SLA method. Another difference is that the fixtures with 6.0mm in diameter have been added to the subject device. To support this dimensional discrepancy, the reference device (K163634) is compared. K163634 has fixtures with 6.0mm and lengths in a range of 7-15mm. Therefore, the surface and dimensional differences do not impact substantial equivalence.
The reference devices' Indications for Use are slightly differ from the subject Indications for Use. However, they do not include any component-specific language relevant to the difference in technology they are being used to support; therefore, the differences do not impact substantial equivalence.
Non-Clinical Test data
The subject device was tested to evaluate its performance and demonstrate substantial equivalence as below.
- Sterilization Validation testing for sterile devices (fixtures) has been performed in accordance ● with ISO 11137, ISO 11737-1& ISO 11737-2 for gamma sterilization
- . Surface Characteristics Test Report - Chemical and SEM image analyses have been performed to verify that there is no residual after SLA treatment on the fixtures.
- Fatigue testing of the predicate device has been performed in accordance with ISO 14801:2007. Since the raw materials, manufacturing process except surface modification method, packaging materials and worst-case geometries are identical between the subject and predicate devices, the test reports can be leveraged for the subject device. The difference in surface treatment is not expected to impact fatigue performance.
- Biocompatibility testing per ISO 10993-1, ISO 10993-5:2009, ISO 10993-10:2010
- . Pyrogenicity testing - All recommended information for an implanted device related to pyrogenicity is provided in accordance with a reference to the FDA Guidance. "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile."
- LAL bacterial endotoxin testing per USP 41 , rev. 05/2018, USP 41 , rev. 05/2018, ANSI/AAMI ST72:2011
- Shelf Life testing has been conducted on the predicate devices (K171297) in accordance with ISO 11607, ISO11137, ASTM F1980. Since the raw materials, manufacturing process, sterilization method, packaging materials and methods are identical between the subject and predicate devices, and surface treatment is not expected to impact shelf life, the test reports can be leveraged for the subject device. To support the accelerated aging shelf life, real aging test has been initiated.
The results of the non-clinical testing demonstrate that the subject device is substantially equivalent to the predicate device.
7
Conclusion:
The AR_N SLA type implant system constitutes a substantially equivalent medical device. This system has the same intended use and fundamental scientific technology as its predicate devices. Therefore, AR_N SLA type implant system and its predicates are substantially equivalent.