(564 days)
No
The device description and performance studies focus on the mechanical properties and biocompatibility of dental abutments, with no mention of AI or ML.
No
The device is a prosthetic component intended for use in dental rehabilitation, not for treating or curing a disease or condition.
No
The device, an abutment, is a prosthetic component used in dental rehabilitation, not for diagnosing medical conditions.
No
The device description clearly states that the device is a premanufactured prosthetic component made from titanium alloy, which is a physical material, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for "prosthetic rehabilitation" by connecting to an endosseous implant. This describes a device used in vivo (within the body) for structural support, not for testing samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a physical component made of titanium alloy designed to be surgically implanted and connected to a dental implant. This is consistent with a medical device used for treatment or restoration, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information. The focus is entirely on the mechanical and structural function of the abutment.
Therefore, the Eco Abutment and Multiunit Abutment are medical devices, but they do not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Eco Abutment is a premanufactured prosthetic component directly connected to an endosseous implant and it is intended for use in prosthetic rehabilitation.
The Multiunit Abutment is a premanufactured prosthetic component directly connected to an endosseous implant and it is intended for use in prosthetic rehabilitation.
Product codes
NHA
Device Description
The Eco Abutment is compatible with following Implant system. The Eco abutments cannot be used with implant diameters less than O3.8mm.
The Multiunit abutment is compatible with following Implant system. The Multiunit abutments cannot be used with implant diameters less than O4.5mm.
Eco Abutment is a two-piece abutment. It consists of a base abutment which is used with temporary post, cemented post, angled post and healing cap. The base abutment is first secured to the dental implant with a base screw and the post is secured to the base abutment with post screw. The Eco Abutment has 4.5, 4.8, 5.5 and 6.5 of diameter and consists of 0, 6, 12 and 18 degree.
The Multiunit Abutment is intended for use in conjunction with the fixture in partially or fully edentulous mandibles and maxillae, in support of single unit loading (i.e., crown) or multi-unit loaded restorations (i.e., bridge, bars, overdentures). It is consists of Multiunit Straight Abutment, Multiunit Angled Abutment and Temporary Cylinder. The Multiunit Abutment has 4.8mm of diameter and consists of two kind of design that has three angles. The Multiunit Straight abutment has 0 degree and the Multiunit Angled abutment has 20 or 30 degree
The Eco Abutment and Multiunit Abutment are made from titanium alloy conforming to ASTM F136. It is provided non-sterile and is steam sterilized before use.
Non-Hex connection abutments are intended for multi-unit restorations only.
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:
- Sterilization Validation: Test results demonstrated that the SAL of 10-6 was achieved and all testing requirements were met.
- Biocompatibility: No new issues of biocompatibility are raised for the subject devices.
- Mechanical Properties: Fatigue testing was performed in accordance with ISO 14801:2016. Comparative fatigue testing was also performed on comparative abutments cleared in K182194. The results of fatigue testing were comparable between the predicate and subject device.
- MR Environment Condition: Non-clinical worst-case MRI review was performed to evaluate the metallic Eco Abutment and Multiunit Abutment in the MRI environment using scientific rationale and published literature.
Clinical Testing:
No clinical studies are submitted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K182194, K173975, K122519, K170608, K080559
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 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.
DIO Corporation % Peter Kang General Manager DIO USA 2729 Bristol St. Costa Mesa, California 92626
Re: K220253
Trade/Device Name: Eco Abutment, Multiunit Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: July 19, 2023 Received: July 19, 2023
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 (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 mediation-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.
Andrew I. Steen -S
Andrew I. 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220253
Device Name Eco Abutment, Multiunit Abutment
Indications for Use (Describe)
Indications for Use for Eco Abutment
The Eco Abutment is a premanufactured prosthetic component directly connected to an endosseous implant and it is intended for use in prosthetic rehabilitation.
Indications for Use for Multiunit Abutment
The Multiunit Abutment is a premanufactured prosthetic component directly connected to an endosseous implant and it is intended for use in prosthetic rehabilitation.
| 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)
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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 bold, sans-serif font, with the "D" and "I" in gray and the "O" in pink. A small pink circle is positioned above and to the right of the "O". Below the letters, the words "Implant Solution" are written in a smaller, sans-serif font.
510(k) Summary - K220253
Submitter
DIO Corporation Han-Seul, Kim 66, Centum Seo-ro, Haeundae-gu Busan, 48058 Republic of Korea Email: khs@dio.co.kr Phone: +82-51-745-7875
Contact/US agent DIO USA Peter Kang 2729 Bristol St., Costa Mesa, California USA Email: peter@dioimplantusa.com Phone: 1-714-8804141
1. Device Information
Trade Name: Eco Abutment, Multiunit Abutment Common Name: Dental Implant Abutment Classification Name: Endosseous dental implant abutment Product Code: NHA Regulation Number: 21 CFR 872.3630 Device Class: Class II Date prepared: August/18/2023
2. Predicate Device
Primary Predicate
K161655 - On1 Concept
Reference Device
K182194 - UV Active Implant System K173975 – UF(II) Wide Fixture K122519 – DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEM K170608 – UF(II) Implant System K080559 – DIO SM IMPLANT SYSTEM
3. Device Description
The Eco Abutment is compatible with following Implant system. The Eco abutments cannot be used with implant diameters less than Ø3.8mm.
| Manufacturer | Compatible Implant System | 510(k) Number | Implant diameter (mm) | Connection type |
|---|---|---|---|---|
| DIO Corporation | UV Active Implant System | K182194 | 3.8/4.0/4.5/5.0/5.5/5.9/6.4 | Internal Hex/Non-hex |
| UF(II) Wide Fixture | K173975 | 5.9/6.4/6.9 | Internal Hex/Non-hex | |
| UF Submerged Implant system | K122519 | 3.8/4.0/4.5/5.0/5.5/5.9/6.4/6.9 | Internal Hex/Non-hex | |
| UF(II) Implant System | K170608 | 3.8/4.0/4.5/5.0/5.5 | Internal Hex/Non-hex |
4
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 "DI" portion of the logo is in gray, while the "O" is in pink with a pink dot above it. Below the letters, the words "Implant Solution" are written in a smaller, sans-serif font, also in gray.
The Multiunit abutment is compatible with following Implant system. The Multiunit abutments cannot be used with implant diameters less than Ø4.5mm.
| Manufacturer | Compatible Implant
System | 510(k)
Number | Implant diameter
(mm) | Connection
type |
|--------------------------------|------------------------------|-----------------------------|--------------------------|-------------------------|
| DIO
Corporation | UV Active Implant
System | K182194 | 4.5/5.0/
5.5/5.9/6.4 | Internal
Hex/Non-hex |
| UF(II) Wide Fixture | K173975 | 5.9/6.4/6.9 | Internal
Hex/Non-hex | |
| UF Submerged
Implant system | K122519 | 4.5/5.0/
5.5/5.9/6.4/6.9 | Internal
Hex/Non-hex | |
| UF(II) Implant System | K170608 | 4.5/5.0/
5.5 | Internal
Hex/Non-hex | |
Eco Abutment is a two-piece abutment. It consists of a base abutment which is used with temporary post, cemented post, angled post and healing cap. The base abutment is first secured to the dental implant with a base screw and the post is secured to the base abutment with post screw. The Eco Abutment has 4.5, 4.8, 5.5 and 6.5 of diameter and consists of 0, 6, 12 and 18 degree.
The Multiunit Abutment is intended for use in conjunction with the fixture in partially or fully edentulous mandibles and maxillae, in support of single unit loading (i.e., crown) or multi-unit loaded restorations (i.e., bridge, bars, overdentures). It is consists of Multiunit Straight Abutment, Multiunit Angled Abutment and Temporary Cylinder. The Multiunit Abutment has 4.8mm of diameter and consists of two kind of design that has three angles. The Multiunit Straight abutment has 0 degree and the Multiunit Angled abutment has 20 or 30 degree
The Eco Abutment and Multiunit Abutment are made from titanium alloy conforming to ASTM F136. It is provided non-sterile and is steam sterilized before use.
Non-Hex connection abutments are intended for multi-unit restorations only.
5
Image /page/5/Picture/1 description: The image shows the logo for DIO Implant Solution. The logo consists of the word "DIO" in a bold, sans-serif font, with the "O" in pink and the rest of the letters in gray. There is a pink circle above and to the right of the "O". Below the word "DIO" are the words "Implant Solution" in a smaller, gray, sans-serif font.
4. Indications for Use
The Eco Abutment is a premanufactured prosthetic component directly connected to an endosseous implant and it is intended for use in prosthetic rehabilitation
The Multiunit Abutment is a premanufactured prosthetic component directly connected to an endosseous implant and it is intended for use in prosthetic rehabilitation
5. Comparison of Technological Characteristics with the Predicate Device.
| Subject Device | Primary Predicate Device | Reference Device | Remark | ||
|---|---|---|---|---|---|
| Applicant | DIO Corporation | Nobel Biocare AB | DIO Corporation | - | |
| Trade Name | Eco Abutment | On1 Concept | UV Active Implant system - | ||
| Multi-unit Abutment | - | ||||
| 510(k) No. | K220253 | K161655 | K182194 | - | |
| Classification | |||||
| Name | Endosseous Dental Implant, | ||||
| Abutment (872.3630) | Endosseous Dental Implant, | ||||
| Abutment (872.3630) | Endosseous Dental Implant | ||||
| (872.3640) | - | ||||
| Product Code | NHA | NHA | DZE, NHA | - | |
| Class | II | II | II | - | |
| Indications | |||||
| For Use | The Eco Abutment is a | ||||
| premanufactured prosthetic | |||||
| component directly connected to | |||||
| an endosseous implant and it is | |||||
| intended for use in prosthetic | |||||
| rehabilitation. | The On1™ device is a | ||||
| premanufactured prosthetic | |||||
| component directly | |||||
| connected to an endosseous | |||||
| implant and it is intended | |||||
| for use in prosthetic | |||||
| rehabilitation. | The UV Active Implant | ||||
| System is indicated for | |||||
| surgical placement in the | |||||
| upper and lower jaw arches, | |||||
| to provide a root form | |||||
| means for single or multiple | |||||
| units' prosthetic attachment | |||||
| to restore a patient's | |||||
| chewing function. |
The narrow (⌀3.0, ⌀3.3)
implant is limited to the
replacement of maxillary
lateral incisors and
mandibular incisors. It is
intended for delayed
loading.
The Regular (⌀3.8 ~ ⌀5.5)
implants can be placed with
a conventional two stage
surgical process with an
option for transmucosal
healing or they can be
placed in a single stage
surgical process for
immediate loading when
good primary stability is
achieved with appropriate
occlusal loading.
The Wide (⌀6.0 ~ ⌀6.4) | Same | |
| | Subject Device | Primary Predicate Device | Reference Device | Remark | |
| | | | a conventional two stage
surgical process with an
option for transmucosal
healing and are indicated
for the molar region with
delayed loading | | |
| Material | Eco Base Abutment, Eco Cemented
post, Eco Angled post, Temporary
Post
: Ti-6Al-4V ELI (ASTM F136) | 0n1 Base, Temporary
Abutment, On1 Healing Cap,
Esthetic Abutment Titanium,
Clinical Screws and Prosthetic
Screws - Titanium vanadium
alloy (ASTM F1472, ASTM
F136)
On1 Esthetic Abutment
Zirconia – Y-TZP zirconium
oxide (ISO 6872, ISO 13356) | Ti-6Al-4V ELI (ASTM F136) | Same | |
| Design | - Post (Eco Cemented post, Eco
Angled post, Eco Temporary post):
Divided into Hex/Non-Hex
connection
-Eco Base Abutment: Divided into
Hex/Non-Hex connection | 2 piece (base placed either
at time of implant
placement or with final
abutment)
Abutment shape fixed | Multiunit Abutment:
Divided into Hex/Non-Hex
Connection | Similar;
Except for its
shape | |
| Diameters
(mm) | 4.5/4.8/5.5/6.5 | At base 4.8/5.3/6.5 | 4.8 | Different but
similar range | |
| Length (mm) | Combined base abutment and post
height
Cemented post -
5.5/6.5/7.0/7.5/8.0/8.5/9.0/9.5/
10.0/10.5/11.0/11.5/12.5
Angled post -
9.5/10.5/11.5/12.5/13.5
Temporary post -
5.5/6.5/7.0/7.5/8.0/8.5/9.0/9.5/
10.0/10.5/11.0/11.5/12.5/13.5/1
4.5 | Combined base and post
height.
Temporary Abut - 8.3 /9.0
Esthetic Abut Ti - 8.2/9.0
Esthetic Abut Zi - 8.2/9.0 | 10.3/11.3/12.3/13.3 | Similar;
Longer range
than
predicate | |
| Gingival
heights (mm) | 1.5/2.5/3.5/4.5/5.5 | 2.0/3.5 | 1.5/2.5/3.5/4.5/5.5 | Same; | |
| Angle | Eco Base abutment & Eco
Cemented post: 0°
Eco Base abutment & Eco Angled
post: 6°/12°/18° | No abutment angulation | 0 °/ 20 ° / 30° | Similar;
Within range
of reference
device. | |
| Sterile | Steam Sterilization by user
(Delivered non sterile) | Steam Sterilization by user
(Delivered non sterile) | Steam Sterilization by user
(Delivered non sterile) | Same | |
| Type of
Retention | Screw-retained or cemented
retained | Screw-retained or cemented
retained | Screw-retained or cemented
retained | Same | |
| Substantial Equivalence Discussion | | | | | |
| | Subject Device | Primary Predicate Device | Reference Device | Remark | |
| Similarities | | | | | |
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Image /page/6/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 letters "DI" are in gray, while the "O" is in pink and has a small pink circle above it. Below the letters, the words "Implant Solution" are written in a smaller, gray font.
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. The "DI" is in gray, while the "O" is in pink and has a small pink circle above and to the right of it. Below the letters, in a smaller font, are the words "Implant Solution".
The subject device is a two-piece abutment. It consists of Eco Base abutment and 3 types of post (Cemented, Angled and Temporary).
The subject device has the same indications for use compared to the predicate device (K161655) and design (except for its shape), identical material composition and manufacturing methods by the same manufacturer compared to the reference device (K182194). The Indications for Use Statement has minor differences; however has the same intended use as being used with Endosseous dental implant to support a single or multiple prosthetic devices.
Differences
The diameter and lengths are different compared to the predicate device; however, the 4.5~6.5mm for the subject device and 4.8, 5.3 and 6.5mm for the predicate devices is comparable.
The total length of 5.5 to 14.5 mm for the subject device is an extended range compared to the predicate devices. To account for these differences, fatigue testing was conducted in accordance with ISO 14801 to verify that subject device is substantially equivalent to the predicate devices. The results of fatigue testing were comparable between the predicate and subject device.
Discussion
The subject device is similar in fundamental scientific technology to the predicate device (K161655) in that they have been designed in compliance with FDA's Class II special controls guidance document root-form Endosseous dental implants and Endosseous dental implant abutment. There are slight mechanical differences between subject devices which was evaluated through comparative performance testing. The documentation submitted in the premarket notification demonstrates that the subject device is substantially equivalent to the predicate devices.
Therefore, we conclude that the Eco Base abutment is substantially equivalent to the predicate device.
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Image /page/8/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.
2) Multiunit Abutment
| Subject Device | Reference Device | Remark | |
|---|---|---|---|
| Applicant | DIO Corporation | DIO Corporation | - |
| Trade Name | Multiunit Abutment | UV Active Implant system – Multi-unit Abutment | - |
| 510(k) No. | K220253 | K182194 | - |
| Classification Name | Endosseous Dental Implant, Abutment (872.3630) | Endosseous Dental Implant (872.3640) | - |
| Product Code | NHA | DZE, NHA | - |
| Class | II | II | - |
| Indications For Use | The Multiunit Abutment is a premanufactured prosthetic component directly connected to an endosseous implant and it is intended for use in prosthetic rehabilitation. | The UV Active Implant System is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic attachment to restore a patient's chewing function. |
The narrow (Ø3.0, Ø3.3) implant is limited to the replacement of maxillary lateral incisors and mandibular incisors. It is intended for delayed loading.
The Regular (Ø3.8 ~ Ø5.5) implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading when good primary stability is achieved with appropriate occlusal loading.
The Wide (Ø6.0 ~ Ø6.4) implants can be placed with a conventional two stage surgical process with an option for transmucosal healing and are indicated for the molar region with delayed loading. | Similar – The reference device include both implant bodies and abutments. |
| Material | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI (ASTM F136) | Same |
| Design | Multiunit Straight
Image: Multiunit Straight
Multiunit Angled
Image: Multiunit Angled Hex
Image: Multiunit Angled Non-Hex | Multiunit Straight
Image: Multiunit Straight
Multiunit Angled
Image: Multiunit Angled Hex
Image: Multiunit Angled Non-Hex | Same |
| Diameters (mm) | 4.8 | 4.8 | Same |
| Cuff size (mm) | 2.5/3.0/3.5/4.5/5.5/6.5/7.5 | 1.5/2.5/3.5/4.5/5.5 | Similar; Subject device has longer range compared to reference device |
| Connected | Regular type | Regular type | Same |
| | Subject Device | Reference Device | Remark |
| fixture type | | | |
| Angle(°) | 0/20/30 | 0/20/30 | Same |
| Sterile | Steam Sterilization by user (Delivered non
sterile) | Steam Sterilization by user (Delivered non
sterile) | Same |
| Type of
Retention | Screw-retained or cement retained | Screw-retained or cement retained | Same |
9
Image /page/9/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" portion of the logo is in gray, while the "O" is in pink and has a small pink circle above and to the right of it. Below the logo, in a smaller font, are the words "Implant Solution".
Substantial Equivalence Discussion
Similarities
The subject device has the same indications for use compared to the predicate device (K161655) and design, and manufacturing methods and by the same manufacturer as the reference device (K182194). The Indications for Use Statement has minor differences; however has the same intended use as being used with Endosseous dental implant to support a single or multiple prosthetic devices.
Differences
The subject device is substantially equivalent to the indication for use, connected fixture type, design and angle as compared to the predicate devices, but includes additional specifications in order to cover different clinical situations. The subject device has additional cuff sizes as compared to the predicate devices. To account for these differences, fatigue testing was conducted in accordance with ISO 14081 to verify substantial equivalence with the predicate device. The results of the fatigue testing were comparable between the predicate and subject device.
Discussion
There are slight mechanical differences between the subject devices. These differences were evaluated through comparative performance testing. The documentation submitted it the premarket notification demonstrates that the subject device is substantially equivalent to the marketed devices.
Therefore, we conclude that the Multiunit abutment is substantially equivalent to the predicate device.
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Image /page/10/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 and to the right of it. Below the letters, in a smaller font, are the words "Implant Solution" in gray.
6. Summary of Non-clinical 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 device.
Sterilization Validation
The subject device is provided non-sterile. Sterilization has been performed in accordance with ISO 17665-1 and ISO 17665-2 for steam sterilization. Test results have demonstrated that the SAL of 10-6 was achieved and all testing requirements were met. Also, Sterilization Validation was conducted according to FDA Guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling".
Biocompatibility
Biocompatibility tests were conducted in accordance with 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" and ISO 10993-10, ISO 10993-10, ISO 10993-23, ISO 10993-11, ISO 10093-3, and ISO 10993-6. The Abutments have the identical nature of body contact, contact duration, material formulation, manufacturing processes, and sterilization methods compared to the reference devices, K182194 and K080559. No new issues of biocompatibility are raised for the subject devices.
Mechanical Properties
Fatigue testing was performed on the subject device including both the eco abutments and multiunit abutments in accordance with ISO 14801:2016 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".
Comparative fatigue testing was also performed on comparative abutments cleared in K182194.
MR Environment Condition
Non-clinical worst-case MRI review was performed to evaluate the metallic. Eco Abutment and Multiunit Abutment in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry 0., Jana G. Delfino, and Sunder Rajan. 'Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices.' Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodied, dental abutments and, fixation screws) and material composition. Rationale addressed parameters per the FDA Guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque.
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7. Summary of Clinical Testing
No clinical studies are submitted.
8. Conclusions
The Eco Abutment and Multiunit Abutment constitute a substantially equivalent medical device, meeting all the declared requirements of its intended use. These abutments have the same intended use and fundamental scientific technology as its predicate device. Therefore, Eco Abutment and Multiunit Abutment and its predicates are substantially equivalent.
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