(164 days)
No
The device description and performance studies focus on the mechanical properties and fatigue testing of a physical dental abutment, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is described as a "retention device" and "support for overdentures," which indicates a functional and structural role rather than directly treating a disease or condition.
No
The device is a retention device designed to support overdentures, not to diagnose a medical condition.
No
The device description clearly states it is a physical implant component made from Ti-6Al-4V ELI (ASTM F136) and includes components like abutment screws, set screws, and abutment caps. It also mentions non-clinical testing involving fatigue testing of assembled implant/abutment systems, which is characteristic of hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "retention device" used in conjunction with a fixture to "provide support for overdentures." This is a mechanical function within the body.
- Device Description: The description details the physical components (abutment, set screw, cap, bar, clip) and their role in supporting a dental prosthesis. It describes a physical implant system.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or condition. IVDs are used for diagnostic purposes.
- Anatomical Site: The device is used within the mouth (maxillary and/or mandibular arch), which is a direct interaction with the patient's anatomy, not a laboratory test.
In summary, the UF(II) Bar holder abutment is a dental prosthetic component, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The UF(II) Bar holder abutment is intended to be used as a retention device in conjunction with the fixture in the maxillary and/or mandibular arch to provide support for overdentures for partially and fully edentulous patients.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
UF(II) Bar holder abutment and set screw is used for prosthetic restoration. Bar holder abutment is intended to be used in conjunction with the fixture in the maxillary and/or mandibular arch to provide support for overdentures for partially and fully edentulous patients. UF(II) Bar holder abutments are made from Ti-6Al-4V ELI (ASTM F136). The UF(II) Bar holder abutment has two type shape which are Single body type and Cap type.
The UF(II) Bar holder abutment of single body type consists of abutment screw and set screw. The UF(II) Bar holder abutment of cap type consists of abutment screw, set screw and abutment cap. Both type Bar holder abutment has Hex, Non-Hex connection. Subject abutments are only intended for multi-unit restorations. It is provided non-sterile, this should be user steam sterilized before use. It is used for overdentures with clip for bar retention. The clip is fixed to the overdenture and used to supplement the retention of the bar and denture. The bar is used to fix the abutment and overdenture. It is held in place with the set screw. The cap is used to cover the bar holder abutment Cap Type. The components-clip, bar, and cap--are included in the device system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary and/or mandibular arch
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 was conducted in accordance with FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments", and it consisted of testing finished assembled implant/abutment systems of the worst-case scenario, (smallest diameter with maximum angulation) through fatigue testing. The results of the non-clinical testing demonstrate that the results have met the criteria of the standards, and the subject device is substantially equivalent to the predicate/reference devices.
Fatigue Test:
The fatigue test was performed on the subject device in accordance with ISO 14801:2007 Dentistry-Implants-Dynamic fatigue test for Endosseous Dental Implants. The worst-case scenario was chosen based on the FDA guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments".
Sterilization Validation and Shelf Life Testing:
User Sterilization Validation Report performed in K181037 was leveraged for the subject device. Sterilization validating testing in K181037 has been performed in accordance with ISO 17665-2 for steam sterilization. Test results have demonstrated that the SAL of 10- was achieved and all testing requirements were met. The subject devices are provided non-sterile status.
Biocompatibility:
The Biocompatibility Test are leveraged from own reference device (K161987).
The biocompatibility test report of the Ti-6Al-4V ELI (ASTM F136) in own reference device (K161987) was provided per the FDA Guidance Document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process". Ti-6AI-4V ELI (ASTM F136) used for the subject device and own reference device (K161987) is exactly same from same manufacturer. The reference device (K161987) support substantial equivalences because same manufacturing process and material are used for subject and own predicate device. No new issues of biocompatibility are raised for the subject devices. Therefore, no additional biocompatibility testing was required.
No clinical testing was performed for this submission.
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.
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.
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.)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 18, 2020
DIO Corporation % Joyce Kwon CEO Provision Consulting Group Inc. 100 N. Barranca Street, Suite 700 West Covina, California 91791
Re: K193404
Trade/Device Name: UF(II) Bar holder abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: February 6, 2020 Received: February 18, 2020
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.
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) K193404
Device Name UF(II) Bar holder abutment
Indications for Use (Describe)
The UF(II) Bar holder abutment is intended to be used as a retention device in conjunction with the fixture in the maxillary and/or mandibular arch to provide support for overdentures for partially and fully edentulous patients.
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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Image /page/3/Picture/1 description: The image shows the logo for DIO Implant Solution. The logo consists of the letters "DIO" in a stylized font, with "DI" in gray and "O" in pink with a pink dot above it. Below the letters, the words "Implant Solution" are written in a smaller, gray font.
K193404 510(k) Summary
This 510(k) Summary is being submitted in accordance with requirement of 21 CFR part 807.92
Submitter:
JiAe, Park DIO Corporation 66 Centum seo-ro, Haeundae-gu, Busan, 48058, Republic of Korea Phone +82-51-745-7836 Fax +82-51-745-7781
Official correspondent:
Joyce Kwon Provision Consulting Group 100 N. Barranca St. Suite 700, West Covina, CA 91791 Email: Info@provisionfda.com Phone: 1-909-493-3276
Device Information:
Trade Name: UF(II) Bar holder abutment Common Name: Endosseous dental implant abutment Classification Name: Abutment, Implant, Dental, Endosseous Product Code: NHA Panel: Dental Regulation Number: 21 CFR 872.3630 Device Class: Class II Date prepared: 05/18/2020
General Description
UF(II) Bar holder abutment and set screw is used for prosthetic restoration. Bar holder abutment is intended to be used in conjunction with the fixture in the maxillary and/or mandibular arch to provide support for overdentures for partially and fully edentulous patients. UF(II) Bar holder abutments are made from Ti-6Al-4V ELI (ASTM F136). The UF(II) Bar holder abutment has two type shape which are Single body type and Cap type.
The UF(II) Bar holder abutment of single body type consists of abutment screw and set screw. The UF(II) Bar holder abutment of cap type consists of abutment screw, set screw and abutment cap. Both type Bar holder abutment has Hex, Non-Hex connection. Subject abutments are only intended for multi-unit restorations. It is provided non-sterile, this should be user steam sterilized before use. It is used for overdentures with clip for bar retention. The clip is fixed to the overdenture and used to supplement the retention of the bar and denture. The bar is used to fix the abutment and overdenture. It is held in place with the set screw. The cap is used to cover the bar holder abutment Cap Type. The components-clip, bar, and cap--are included in the device system.
Indication For Use
The UF(II) Bar holder abutment is intended to be used as a retention device in conjunction with the fixture in the maxillary and/or mandibular arch to provide support for overdentures for partially and fully edentulous patients.
Predicate devices
The subject device is substantially equivalent to the following Predicate Device: Primary Predicate Device: ERA® Micro 23° and 30° Female Abutment (K130408)
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Image /page/4/Picture/1 description: The image shows the logo for DIO Implant Solution. The logo consists of the letters "DIO" in a bold, sans-serif font. The "DIO" letters are in gray, except for the dot over the "i", which is pink. Below the letters, the words "Implant Solution" are written in a smaller, sans-serif font, also in gray.
Reference Device: UF(II) Narrow Implant System (K161987) DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEM, Ball abutment (K122519) DIO CAD/CAM Abutment (K181037)
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Image /page/5/Picture/1 description: The image shows the logo for DIO Implant Solution. The logo has the text "DIO" in gray, with the "O" in pink and a pink dot above it. Below the text "DIO" is the text "Implant Solution" in gray. The logo is simple and modern.
Summaries of Technological Characteristics
The subject device is substantially equivalent of the are substantially equivalent in intended use, material and connection interfaces to the implants are identical for each individual diameter and connection demonstrating Substantial Equivalence follows:
| Subject Device | Primary Predicate Device | Reference Device | |||
|---|---|---|---|---|---|
| Applicant | DIO Corporation | Sterngold Dental, LLC | DIO Corporation | DIO Corporation | DIO Corporation |
| Trade Name | Bar holder abutment | ERA® Micro 23° and 30° | |||
| Female Abutment | DIO UF HSA INTERNAL | ||||
| SUB-MERGED | |||||
| IMPLANT SYSTEM, Ball | |||||
| abutment | UF(II) Narrow Implant | ||||
| System | DIO CAD/CAM Abutment | ||||
| 510(K) No. | Not yet assigned | K130408 | K122519 | K161987 | K181037 |
| Classification | |||||
| Name | Endosseous Dental Implant | ||||
| Abutments (872.3630) | Endosseous Dental Implant | ||||
| Abutments (872.3630) | Endosseous Dental Implant | ||||
| Abutments (872.3630) | Endosseous Dental Implant | ||||
| Abutments (872.3630) | Endosseous Dental Implant | ||||
| Abutments (872.3630) | |||||
| Product Code | NHA | NHA | NHA | NHA | NHA |
| Class | II | II | II | II | II |
| Material | Ti-6Al-4V ELI | ||||
| (ASTM F136) | Ti-6Al-4V ELI | ||||
| (ASTM F136) | Ti CP-4 (ASTM F67) | Ti-6Al-4V ELI | |||
| (ASTM F136) | Ti-6Al-4V ELI | ||||
| (ASTM F136) | |||||
| Surface | |||||
| treatment | Machined | TiN Coated | Machined | Machined | Machined |
| Design | Image: Bar holder abutment | Image: ERA® Micro 23° and 30° Female Abutment | Image: DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEM, Ball abutment | Image: UF(II) Narrow Implant System | N/A |
| Diameters | |||||
| (mm) | 4.5 | not defined | 3.5 | 3.5 | 3.0/3.3/3.8/4.0/4.5/5.0/5.5/6.0/6.5/7.0 |
| Height (mm) | 6.5/7.0/8.0/9.0/ | not defined | 4.5/5.5/6.5/7.5/8.5/9.5 | 4.5/5.5/6.5/7.5/8.5/9.5/10.5 | 3.1~14.9 |
| Angulation | 0° | 23°, 30° | 0° | 0° | 0°~15° |
| Sterilization | Steam Sterilization by user | ||||
| (Delivered non-sterile) | Steam Sterilization by user | ||||
| (Delivered non-sterile) | Steam Sterilization by user | ||||
| (Delivered non-sterile) | Steam Sterilization by user | ||||
| (Delivered non-sterile) | Steam Sterilization by user | ||||
| (Delivered non-sterile) | |||||
| Indications | |||||
| For Use/ | |||||
| Intended Use | The UF(II) Bar holder | ||||
| abutment is intended to be | |||||
| used as a retention device | |||||
| in conjunction with the | |||||
| fixture in the maxillary | |||||
| and/or mandibular arch to | |||||
| provide support for | |||||
| overdentures for partially | |||||
| and fully edentulous | |||||
| patients. | The ERA® Micro 230 and | ||||
| 300 Females are intended | |||||
| to be used as a retention | |||||
| device in conjunction with | |||||
| the Sterngold Acid Etch | |||||
| Dental Implant System in | |||||
| the maxillary and/or | |||||
| mandibular arch to provide | |||||
| support for overdentures | |||||
| for partially and fully | |||||
| edentulous patients. | Ball Abutment can be used | ||||
| to prepare fully or partially | |||||
| over denture. Ball | |||||
| Abutment system consists | |||||
| of ball abutment, retainer, | |||||
| ball abutment cap, and ball | |||||
| analog. | Ball Abutment is intended | ||||
| for use in conjunction with | |||||
| the fixture in partially or | |||||
| fully endentulous | |||||
| mandibles and maxillae and | |||||
| used for producing denture. | DIO CAD/CAM Abutment | ||||
| is intended for use with | |||||
| dental implants as a support | |||||
| for single or multiple tooth | |||||
| prostheses in the maxilla or | |||||
| mandible of a partially or | |||||
| fully edentulous patient. | |||||
| Similarities: | |||||
| UF(II) Bar holder abutment is substantially equivalent in indications for use as Primary Predicate device (K130408), while material, sterilization, | |||||
| angulation, packaging, manufacturing process and technological characteristics are same as its reference devices K122519, and K161987. | |||||
| Substantial | |||||
| Equivalence | |||||
| Discussion | Differences: | ||||
| The subject device and reference devices are different in shape and dimension. To support this discrepancy, we performed the fatigue test. | |||||
| The subject device's length is different from reference device (K161987). However, the subject device length is in the range of length of reference | |||||
| device (K161987). The subject device has a difference in the technological characteristic that the device is designed to maintain a denture bar for | |||||
| clipping a removable denture. The identified reference predicates are ball attachment types. | |||||
| The UF(II) Bar holder Abutment is identical in fundamental scientific technology to the predicate and reference devices in that they all have | |||||
| been designed, manufactured and tested in compliance with FDA's Class II special controls guidance document root-food endosseous dental | |||||
| implants and endosseous dental implant abutments. | |||||
| Any differences in technology characteristics are accompanied by information that demonstrated the device is substantially equivalent as the | |||||
| predicate device and do not raise different questions of safety and effectiveness than the predicate. |
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DIO Corporation Traditional 510(k) Submission UF(II) Bar holder abutment(K193404)
Image /page/6/Picture/1 description: The image shows the logo for DIO Implant Solution. The logo consists of the letters "DIO" with "DI" in gray and "O" in pink. Below the letters, the words "Implant Solution" are written in gray.
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Image /page/7/Picture/1 description: The image shows the logo for DIO Implant Solution. The logo consists of the letters "DIO" in a bold, sans-serif font. The "DI" is in gray, while the "O" is in pink with a small pink circle above it. Below the letters, the words "Implant Solution" are written in a smaller, gray font.
Non-clinical Testing
Non-clinical testing was conducted in accordance with FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments", and it consisted of testing finished assembled implant/abutment systems of the worst-case scenario, (smallest diameter with maximum angulation) through fatigue testing. The results of the non-clinical testing demonstrate that the results have met the criteria of the standards, and the subject device is substantially equivalent to the predicate/reference devices.
Fatigue Test
The fatigue test was performed on the subject device in accordance with ISO 14801:2007 Dentistry-Implants-Dynamic fatigue test for Endosseous Dental Implants. The worst-case scenario was chosen based on the FDA guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments".
The subject device was tested to evaluate its substantial equivalence according to the following standards. - Fatigue Test according to ISO 14801:2007
Fatigue Test according to ISO 11601:2007
Sterilization Validation and Shelf Life Testing
User Sterilization Validation Report performed in K181037 was leveraged for the subject device. Sterilization validating testing in K181037 has been performed in accordance with ISO 17665-2 for steam sterilization. Test results have demonstrated that the SAL of 10- was achieved and all testing requirements were met. The subject devices are provided non-sterile status.
Biocompatibility
The Biocompatibility Test are leveraged from own reference device (K161987).
We provided the biocompatibility test report of the Ti-6Al-4V ELI (ASTM F136) in own reference device (K161987) per the FDA Guidance Document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process". Ti-6AI-4V ELI (ASTM F136) used for the subject device and own reference device (K161987) is exactly same from same manufacturer. The reference device (K161987) support substantial equivalences because same manufacturing process and material are used for subject and own predicate device. No new issues of biocompatibility are raised for the subject devices. Therefore, no additional biocompatibility testing was required.
Summary of clinical testing
No clinical testing was performed for this submission.
Conclusions
The UF(II) Bar holder abutment constitutes a substantially equivalent medical device. This system has the same intended use and fundamental scientific technology as its predicate and reference devices. Therefore, UF(II) Bar holder abutment sand its predicates are substantially equivalent.