(339 days)
No
The summary describes a standard dental implant system and its non-clinical testing, with no mention of AI or ML technologies.
Yes
The device is a dental implant system intended to replace missing teeth, which constitutes a therapeutic intervention to restore function and anatomy.
No
The device is described as a "dental implant system" intended for surgical placement in the bone to replace missing teeth, not for diagnosing medical conditions.
No
The device description explicitly states it is a "dental implant system made of CP Ti Gr 4, intended to be surgically placed in the bone," indicating it is a physical hardware device. The performance studies also focus on sterilization, surface characteristics, and biocompatibility testing of a physical implant.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a dental implant system for surgical placement in the bone of the jaw to support dental restorations. This is a surgical and prosthetic device, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description reinforces that it's a physical implant made of CP Ti Gr 4, surgically placed in the bone.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on specimens, or providing diagnostic information based on such analysis.
- Performance Studies: The performance studies focus on sterilization, material characteristics, biocompatibility (cytotoxicity, sensitization), and mechanical properties (fatigue testing), which are typical for implantable medical devices, not IVDs.
Therefore, the BR SLA Type Implant System is a medical device, specifically a dental implant, and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
BR 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. BR SLA Type Implant System is for single and two-stage surgical procedures. It is intended for delayed loading.
Product codes
DZE, NHA
Device Description
The BR SLA Type Implant System is a dental implant system made of CP Ti Gr 4, intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implants 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 implants has been treated with S.L.A.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Non-Clinical Testing:
- Sterilization validation testing for sterile devices (fixtures) has been performed in accordance with ISO 11137, ISO 11737-1 & ISO 11737-2 for gamma sterilization
- Steam sterilization validation for non-sterile devices (abutments) has been performed in accordance with ISO 17665-1 and 17665-2.
- Surface characteristics test report Chemical and SEM image analysis have been performed to verify that there is no residual after SLA treatment on the fixtures.
- Cytotoxicity test performed according to ISO 10993-5:2009
- Sensitization test performed according to ISO 10993-10:2010
- LAL Endotoxin lot release testing according to USP
- Shelf life testing performed according to ISO 11607
Key results: The result of the above tests has met the criteria of the standard and proved the substantial equivalence with the predicate device. Non-clinical testing consisted of a performance of testing in accordance with the FDA guidance "Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." The fatigue testing was leveraged from the predicate device. The result of the non-clinical testing demonstrates 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.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
Biotem Co., Ltd. % Joyce Kwon CEO Provision Consulting Group, Inc. 100 N Barranca St. Suite 700 West Covina, California 91791
Re: K222142
Trade/Device Name: BR SLA Type Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: May 19, 2023 Received: May 19, 2023
Dear Joyce Kwon:
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.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov
6/24/23
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 (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 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.
Sherrill Lathrop Blitzer
for Andrew Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K222142
Device Name BR SLA Type Implant System
Indications for Use (Describe)
BR 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. BR SLA Type Implant System is for single and two-stage surgical procedures. It is intended for delayed loading.
| Type of Use (Select one or both, as applicable) |
|---|
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Image /page/3/Picture/0 description: The image shows the logo for Provision Consulting Group. The logo features a stylized bird with several wing feathers on the left side. To the right of the bird is the word "PROVISION" in a bold, sans-serif font, with the words "CONSULTING GROUP" in a smaller font underneath.
510(k) Summary
510(k) Submitter
Hong Koo Yeo Biotem Co., Ltd. 57. Sasang-ro. 401 beon-gil. Sasang-gu. Busan 46925 Republic of Korea +82-51-908-8257 info@provisionfda.com
Official Correspondent / Contact Person
Joyce Kwon, CEO/Principal Consultant Provision Consulting Group, Inc. 100 N. Barranca St. Suite 700 West Covina, CA 91791 +1-909-493-3276 joyce@provisionfda.com
Date Prepared
June 23, 2023
Device Information
- Trade Name: BR SLA Type Implant System
- Model Name: BR SLA Dental Implant
- Common Name: Endosseous dental implant
- Classification Name: Implant, Endosseous, Root-Form ●
- Regulation Number: 21 CFR 872.3640 .
- Device Class: Class II ●
- Product Code: DZE, NHA ●
Predicate Devices
- Biotem BR Type Implant System (K171179) ● Endosseous dental implant
The predicates have not been subject to a design-related recall.
Reference Device
- . AR N SLA Type Implant System (K190641)
Prior Submission Information
None
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Image /page/4/Picture/0 description: The image shows the logo for Provision Consulting Group. The logo features a stylized bird in flight, with its wings represented by a series of curved lines. To the right of the bird is the text "PROVISION" in a bold, sans-serif font, with the words "CONSULTING GROUP" in a smaller font below it.
Indication for Use
The BR 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. BR SLA Type Implant System is for single and two-stage surgical procedures. It is intended for delayed loading.
Device Description
The BR SLA Type Implant System is a dental implant system made of CP Ti Gr 4, intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implants 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 implants has been treated with S.L.A. The BR SLA Type Implant System is offered in the following sizes.
| Diameter | Length (mm) |
|---|---|
| Ø 3.5 | 8.5, 10.0, 11.5, 13.0, 15.0 |
| Ø 4.1 | 7.5, 8.5, 10.0, 11.5, 13.0, 15.0 |
| Ø 5.0 | 7.5, 8.5, 10.0, 11.5, 13.0, 15.0 |
| Ø 5.1 | 7.5, 8.5, 10.0, 11.5, 13.0, 15.0 |
Substantial Equivalent Comparison Chart with Predicate Device and Reference Device
| Subject Device | Primary Predicate Device | Reference Device | |
|---|---|---|---|
| Device Name | BR SLA Type Implant | ||
| System | BR Type Implant System | AR_N SLA Type | |
| Implant System | |||
| 510(k) Number | K222142 | K171179 | K190641 |
| Manufacturer | Biotem Co., Ltd. | Biotem Co., Ltd. | Biotem Co., Ltd. |
| Regulation | |||
| Number | 21 CFR 872.3640 | 21 CFR 872.3640 | 21 CFR 872.3640 |
| Product code | DZE, NHA | DZE, NHA | DZE |
| Class | II | II | II |
| Indications for | |||
| Use | BR 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, screw | |||
| retained, or overdenture | |||
| restorations, and terminal | |||
| or intermediate abutment | |||
| support for fixed | |||
| bridgework. BR SLA | |||
| Type Implant System is | |||
| for single and two stage | |||
| surgical procedures. It is | |||
| intended for delayed | |||
| loading. | BR 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, screw | |||
| retained, or overdenture | |||
| restorations, and terminal | |||
| or intermediate abutment | |||
| support for fixed | |||
| bridgework. BR Type | |||
| Implant System is for | |||
| single and two stage | |||
| surgical procedures. It is | |||
| intended for delayed | |||
| loading. | 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, screw | |||
| 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. | |||
| Design | External Hex Type | External Hex Type | Internal Hex Submerged |
| Macro thread | |||
| Material | CP Ti Gr 4 ASTM F67 | CP Ti Gr 4 ASTM F67 | CP Ti Gr 4 ASTM F67 |
| Sterilization | Gamma sterilization | Gamma sterilization | Gamma sterilization |
| Fixture Diameter | |||
| (mm) | Ø 3.5, 4.1, 5.0, 5.1 mm | Ø 3.5, 4.1, 5.0, 5.1 mm | Ø 3.7, 4.2, 4.6, 5.1, 6.0 |
| mm | |||
| Fixture Length | |||
| (mm) | 7.5, 8.5, 10.0, 11.5, 13.0, | ||
| 15.0 mm | 7.5, 8.5, 10.0, 11.5, 13.0, | ||
| 15.0 mm | 7.5, 8.5, 10.0, 11.5, 13.0, | ||
| 15.0 mm | |||
| Abutment | |||
| Diameter (mm) | Ø 4.0 - 6.0 mm | Ø 4.0 - 6.0 mm | Ø 4.0 - 6.5 mm |
| Abutment Lengths | |||
| (mm) | 4.0 - 12.0 mm | 4.0 - 12.0 mm | 1.0 - 10.0 mm |
| Abutment Angled | 15°, 25° | 15°, 25° | 17°, 30° |
| Attachment | Various abutments and | ||
| components | Various abutments and | ||
| components | Various abutments and | ||
| components | |||
| Surface treatment | SLA | PBM | SLA |
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Image /page/5/Picture/1 description: The image shows the logo for Provision Consulting Group. The logo features a stylized bird with several wing feathers on the left side. To the right of the bird is the word "PROVISION" in a bold, sans-serif font, with the words "CONSULTING GROUP" in a smaller font underneath.
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Image /page/6/Picture/0 description: The image shows the logo for Provision Consulting Group. The logo features a stylized bird with outstretched wings on the left side. To the right of the bird is the word "PROVISION" in a bold, sans-serif font, with the words "CONSULTING GROUP" in a smaller font underneath. The logo has a clean and professional design.
Substantial Equivalence Discussion
The subject device, BR SLA Type Implant System has a substantially equivalent intended use as the identified predicate (K171179). Both are used for mandible and maxilla endosseous dental implant and accessories. The BR SLA Type Implant System has the same basic technology as the predicate device in that they all designed, manufactured and tested in accordance with FDA's Class II Special Controls Guidance Document Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments. The subject and predicate devices are identical in size and material except for surface treatment. When compared with predicate devices, no new questions of substantially equivalence have been raised for the BR SLA Type Implant System.
S.L.A. surface is formed by undergoing the process of sandblasting with smaller than 50um HA (Hydroxy Apa- tite) particles to roughen the machined surface and to form many macropores. After sand blasting and acid etching is done to increase B.I.C (Bone-Implant Contact).
Non-Clinical Testing
The subject device was tested to evaluate its performance 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
- Steam sterilization validation for non-sterile devices (abutments) has been performed in ● accordance with ISO 17665-1 and 17665-2.
- Surface characteristics test report Chemical and SEM image analysis have been ● performed to verify that there is no residual after SLA treatment on the fixtures.
- Cytotoxicity test performed according to ISO 10993-5:2009 ●
- Sensitization test performed according to ISO 10993-10:2010 ●
- LAL Endotoxin lot release testing according to USP ●
- Shelf life testing performed according to ISO 11607 ●
Those tests have been performed to evaluate the substantial equivalence in the surface characteristics compared to the predicate device. The result of the above tests has met the criteria of the standard and proved the substantial equivalence with the predicate device. Non-clinical testing consisted of a performance of testing in accordance with the FDA guidance "Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." The fatigue testing was leveraged from the predicate device. The result of the non-clinical testing demonstrates that the subject device is substantially equivalent to the predicate device.
Conclusion
The subject device and the predicate device have the same intended use and have the same technological characteristics. The subject and predicate implants are all made of commercially pure titanium and have the similar surface treatments.
Overall, the BR SLA Type Implant System has the following similarities to the predicate devices:
- has the same intended use
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Image /page/7/Picture/1 description: The image contains the logo for Provision Consulting Group. The logo features a stylized bird with several feather-like extensions, all in a muted green color. To the right of the bird is the word "PROVISION" in bold, followed by "CONSULTING GROUP" in a smaller font size.
- uses the same operating principle ●
- incorporates the same basic design .
- incorporates the same material .
Based on the similarities, we conclude that the BR SLA Type Implant System is substantially equivalent to the predicate device.