(184 days)
No
The summary describes a dental abutment made of metal alloy for prosthetic restorations and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is described as an abutment used for prosthetic restoration in dentistry, which provides support for crowns, bridges, or overdentures. Its intended use is mechanical support for dental prostheses rather than treatment or diagnosis of a disease or condition.
No
The device is an abutment for dental implants, providing support for prosthetic restorations. It is not described as being used to diagnose conditions or diseases.
No
The device description clearly states it is a physical abutment made from CCM Alloy, consisting of the abutment and an abutment screw. It is a hardware component used in dental restorations.
Based on the provided information, the UCLA CCM Abutment is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide support for prosthetic restorations (crowns, bridges, overdentures) with a dental implant. This is a structural and mechanical function within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the physical characteristics, materials, and how it's used in a dental procedure. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological samples.
- Detecting or measuring specific substances (analytes) in these samples.
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on sample analysis.
The UCLA CCM Abutment is a medical device used in a surgical and restorative dental procedure.
N/A
Intended Use / Indications for Use
UCLA CCM Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
UCLA CCM Abutment is used for prosthetic restoration. It is used for cases with path and aesthetic and spatial constrainsts. After customization, be sure to use only dental non-precious metal for casting to make the prosthesis. When cast a prosthesis with UCLA CCM Abutment, the post height above the transmucosal collar of UCLA CCM Abutment has to be taller than 4mm.
The subject device is not to be used with any angulation and are straight only.
UCLA CCM Abutment has Hex, Non Hex connection. Hex-type abutment should be used for single unit restorations and is not recommended for multiple tooth restorations. Non Hex-type abutment is for multiunit restorations only. Both abutments types are compatible implant bodies (K182194, K161987, K122519, K170608 and K173975).
UCLA CCM Abutments are made from CCM Alloy. UCLA CCM Abutment consists of UCLA CCM Abutment and abutment screw. It is provided non-sterile, this should be user steam sterilized before use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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. The results of the non-clinical testing demonstrate that the results have met the standards, and the subject device is substantially equivalent to the predicate device.
Since the design does not include any angulation, fatigue testing was not conducted.
Sterilization validating testing has been performed in accordance with ISO 17665-1 and ISO 17665-2 for steam sterilization. Test results have demonstrated that the SAL of 10th was achieved and all testing requirements were met. The subject device is leveraged sterilization from K181037.
For the subject devices provided non-sterile status.
The Biocompatibility Test are leveraged from own predicate device (K182194). We provided the biocompatibility test report of the CoCrMo Alloys in own predicate device (K182194) 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". CoCrMo Alloys used for the subject device and own predicate device (K182194) is exactly same manufacturer. The predicate device (K182194) support substantial equivalences because same manufacturing process and material are used for subject and own reference 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.
K182194, K181037, K161987, K122519, K170608, K173975
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & 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 is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.
February 21, 2020
DIO Corporation % Peter Kang Business, Manager DIO USA 3470 Wilshire Blvd. #620 Los Angeles, California 90010
Re: K192263
Trade/Device Name: UCLA CCM Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: January 21, 2020 Received: January 23, 2020
Dear Peter Kang:
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.
Srinivas Nandkumar, Ph.D. for 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K192263
Device Name UCLA CCM Abutment
Indications for Use (Describe)
UCLA CCM Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
| 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) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Image /page/3/Picture/1 description: The image shows the logo for DIO Implant Solution. The logo has the letters "DIO" in a sans-serif font. The "DI" is in gray, and the "O" is in pink with a small pink circle above and to the right of it. Below the letters is the text "Implant Solution" in a smaller, sans-serif font.
510(k) Summary
K 192263
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 +82-51-745-7781 Fax
Contact / US agent:
Peter Kang DIO USA. 3470 Wilshire Blvd. #620 Los Angeles, CA Phone +1-213-365-2875 +1-213-365-1595 Fax
Device Information:
Trade Name: UCLA CCM abutment Classification Name: Endosseous dental implant abutment Regulation Number: 21 CFR 872.3630 Product Code: NHA Panel: Dental Device Class: Class II Date prepared: 02/21/2020
Indication For Use
UCLA CCM Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
Predicate devices
The subject device is substantially equivalent to the following Predicate Device: Primary predicate : NP-Cast Abutment System (K121843) Reference Devices : UV Active Implant System, CCM Cylinder (K182194) DIO CAD/CAM Abutment (K181037) UF(II) Narrow Implant System (K161987) UF Submerged Implant System (K122519) UF(II) Implant System (K170608) UF(II) Wide Fixture (K173975)
General Description
UCLA CCM Abutment is used for prosthetic restoration. It is used for cases with path and aesthetic and spatial constrainsts. After customization, be sure to use only dental non-precious metal for casting to make the prosthesis. When cast a prosthesis with UCLA CCM Abutment, the post height above the transmucosal collar of UCLA CCM Abutment has to be taller than 4mm.
The subject device is not to be used with any angulation and are straight only.
UCLA CCM Abutment has Hex, Non Hex connection. Hex-type abutment should be used for single unit restorations and is not recommended for multiple tooth restorations. Non Hex-type abutment is for multiunit restorations only. Both abutments types are compatible implant bodies (K182194,
Page 1 of 5
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Image /page/4/Picture/1 description: The image shows the logo for DIO Implant Solution. The logo has 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 and to the right of it. Below the letters is the text "Implant Solution" in a smaller, gray, sans-serif font.
K161987, K122519, K170608 and K173975)
UCLA CCM Abutments are made from CCM Alloy. UCLA CCM Abutment consists of UCLA CCM Abutment and abutment screw. It is provided non-sterile, this should be user steam sterilized before use. The UCLA CCM abutment compatible following own predicate Implant system.
| Proprietary
Name | UV Active
Implant
System | UF(II) Narrow
Implant
System | UF Sub
merged
Implant
System | UF(II)
Implant
System | UF(II) Wide
Fixture |
|--------------------------------------------------|---------------------------------------------|------------------------------------|---------------------------------------|-------------------------------------|-------------------------------------|
| Compatible
Implants
(Knumber) | K182194 | K161987 | K122519 | K170608 | K173975 |
| Implant diameter
size(mm) | 3.0/3.3/3.8/4.0/
4.5/5.0/5.5/6.0/
6.5 | 3.0/3.3 | 3.8/4.0/4.5/5.0/
5.5/6.0/6.5/7.0 | 3.8/4.0/45/5.0/5
.5 | 5.9/6.4/6.9 |
| Implant Interface
Connection
Type/Size(mm) | Internal
connection
type/2.3, 3.35 | Internal
connection
type/2.3 | Internal
connection
type/3.35 | Internal
connection
type/3.35 | Internal
connection
type/3.35 |
| Type of Implant-
Abutment
Connection | Hex/Non Hex | Hex/Non Hex | Hex/Non Hex | Hex/Non Hex | Hex/Non Hex |
5
Image /page/5/Picture/1 description: The image shows the logo for DIO Implant Solution. The logo has the letters DIO in gray, with the O stylized as a pink circle with a smaller circle above it. Below the letters, the words "Implant Solution" are written in gray.
Summaries of Technological Characteristics
The subject device is substantially equivalent to the are substantially equivalent in intended use, material and comection interfaces to the implants are identical for each individual diameter and connection demonstrating Substantial Equivalence follows:
| Subject Devices | Primary Devices | Reference Devices | ||||
|---|---|---|---|---|---|---|
| Applicant | DIO Corporation | OSSTEM Implant Co., Ltd. | DIO Corporation | |||
| Trade Name | UCLA CCM Abutment | NP-Cast Abutment System | UV Active Implant System | |||
| CCM Cylinder | ||||||
| 510(K) No. | K192263 | K121843 | K182194 | |||
| Classification | ||||||
| Name | Endosseous Dental Implant Abutments | |||||
| (872.3630) | Endosseous Dental Implant Abutments | |||||
| (872.3630) | Endosseous Dental Implant Abutments | |||||
| (872.3630) | ||||||
| Product Code | NHA | NHA | NHA | |||
| Class | II | II | II | |||
| Material | CCM Abutment | CoCrMo Alloys | CCM Abutment | CoCrMo Alloys | CCM Abutment | CoCrMo Alloys |
| Plastic Sleeve | POM | Plastic Sleeve | POM | Plastic Sleeve | POM | |
| Design | Hex | Non-Hex | Hex | Non-Hex | Hex | Non-Hex |
| Image: Hex | Image: Non-Hex | Image: Hex | Image: Non-Hex | Image: Hex | Image: Non-Hex | |
| Diameters (mm) | 4.0/4.5 | 4.0/4.5 | 4.0/4.5 | 4.0/4.5 | 5.0 | 5.0 |
| Height (mm) | 1.0/3.0 | 1.0/3.0 | 1.0/3.0 | 1.0/3.0 | 2.4 | 2.4 |
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Image /page/6/Picture/1 description: The image shows the logo for DIO Implant Solution. The logo consists of the letters "DIO" in gray, with the "O" stylized as a pink circle with a smaller pink circle inside. Below the letters, the words "Implant Solution" are written in gray, smaller font.
| Maximum
| angulation | 0° | 30° | 15° |
|---|---|---|---|
| Sterilization | 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 | UCLA CCM Abutment is intended for use | ||
| with a dental implant to provide support for | |||
| prosthetic restorations such as crowns, | |||
| bridges, or overdentures. | The NP-Cast Abutment System is intended | ||
| for use with a dental implant to provide | |||
| support for prosthetic restorations such as | |||
| crowns, bridges, or overdentures. | CCM Cylinder is intended for use in | ||
| conjunction with the fixture in partially or | |||
| fully edentulous mandibles and maxillae, in | |||
| support of single or multiple-unit cement | |||
| retained restorations. And it should be used | |||
| with multi-unit abutment. It has Hex and Non- | |||
| hex connection. | |||
| Substantial | |||
| Equivalence | |||
| Discussion | Similarities : | ||
| UCLA CCM Abutment is substantially equivalent in indications for use, material, dimension, sterilization and similar design, technological | |||
| characteristics as primary predicate device (K121843). | |||
| UCLA CCM Abutment has same material, packaging, manufacturing process as own reference device (K182194). | |||
| Differences : | |||
| The subject device and reference devices are different in detailed shape, Indications for use and dimension. To support this discrepancy, | |||
| primary predicate device(K121843) selected in this submission. | |||
| The subject device's maximum angulation is different from primary predicate device (K121843). However, the subject device's maximum | |||
| angulations are in the range of angulation of primary predicate device (K121843). | |||
| The UCLA CCM Abutment is identical in fundamental scientific technology to the predicate device in that they all have been | |||
| designed, manufactured and tested in compliance with FDA's Class II special controls guidance document root-form 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. |
7
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, with "DI" in gray and "O" in pink with a small pink circle above and to the right of it. Below the letters, in a smaller font, are the words "Implant Solution" in gray.
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. The results of the non-clinical testing demonstrate that the results have met the standards, and the subject device is substantially equivalent to the predicate device.
Fatigue Testing
Since the design does not include any angulation, fatigue testing was not conducted.
Sterilization Validation and Shelf Life Testing
Sterilization validating testing has been performed in accordance with ISO 17665-1 and ISO 17665-2 for steam sterilization. Test results have demonstrated that the SAL of 10th was achieved and all testing requirements were met. The subject device is leveraged sterilization from K181037.
For the subject devices provided non-sterile status.
Biocompatibility
The Biocompatibility Test are leveraged from own predicate device (K182194),
We provided the biocompatibility test report of the CoCrMo Alloys in own predicate device (K182194) 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".
CoCrMo Alloys used for the subject device and own predicate device (K182194) is exactly same manufacturer. The predicate device (K182194) support substantial equivalences because same manufacturing process and material are used for subject and own reference 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 UCLA CCM abutment constitutes a substantially equivalent medical device, meeting all the declared requirements of its intended use. This system has the same intended use and fundamental scientific technology as its predicate device. Therefore, UCLA CCM abutment sand its predicates are substantially equivalent.