(263 days)
No
The summary describes a physical dental abutment made of titanium alloy with no mention of software, algorithms, or any AI/ML related terms or concepts.
No
The device is an abutment for dental implants, providing support for prosthetic reconstructions like crowns or bridges, and is not designed to treat a disease or condition.
No
The device is described as an abutment intended to provide support for prosthetic reconstructions like crowns or bridges, which is a therapeutic rather than diagnostic function.
No
The device description clearly states it is a physical abutment made from titanium alloy, intended to be placed into dental implants. It is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the UF(II) Anatomic abutment is a dental implant component intended to be placed into dental implants to support prosthetic reconstructions. It is a physical device used in vivo (within the body) for structural support.
- Lack of Biological Sample Testing: There is no mention of the device being used to test biological samples or provide diagnostic information based on such testing.
The information provided describes a medical device used in dentistry for prosthetic rehabilitation, not a diagnostic test.
N/A
Intended Use / Indications for Use
The UF(II) Anatomic abutment is intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns or bridges. The abutment can be used in single tooth replacements and multiple tooth restorations.
Product codes
NHA
Device Description
The UF(II) Anatomic abutment is intended to be used with the root-form endosseous dental implant to aid in prosthetic rehabilitation. The anatomic abutment has scalloped margins to follow the gingival contour to provide better esthetic results with the final prosthesis. It consist of straight abutment and angled of 5°, 18°, and are made from titanium alloy conforming to ASTM F136. The anatomic abutments are pre-manufactured (stock) abutments 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
Dental implants in the maxilla and/or mandibular arches.
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: Performed in accordance with ISO 17665-1 and ISO 17665-2 for steam sterilization. Test results demonstrated that the SAL of 10-6 was achieved and all testing requirements were met. Sterilization was conducted in accordance with FDA Guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling".
- Fatigue Test: 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".
- Biocompatibility: Leveraged from previous submission (K122519). 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". No new issues of biocompatibility were raised for the subject devices.
Key results: 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.
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
§ 872.3630 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 seal on the left and the FDA acronym and name on the right. The FDA acronym is in a blue square, and the full name "U.S. Food & Drug Administration" is in blue text.
September 30, 2019
DIO Corporation % Peter Kang Business Manager DIO USA 3470 Wilshire Blvd, #620 Los Angeles, California 90010
Re: K190048
Trade/Device Name: UF(II) Anatomic abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: August 28, 2019 Received: August 30, 2019
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.
1
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.
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. Acting Director DHT1B: Division of Dental 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) K190048
Device Name UF(II) Anatomic abutment
Indications for Use (Describe)
The UF(II) Anatomic abutment is intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns or bridges. The abutment can be used in single tooth replacements and multiple tooth restorations.
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 has the letters "DIO" in a 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 is the text "Implant Solution" in a smaller, gray, sans-serif font.
510(k) Summary
K190048
This 510(k) Summary is being submitted in accordance with requirement of 21 CFR part 807.92
Submitter:
DIO Corporation JiAe, Park 66 Centum seo-ro, Haeundae-gu, Busan, 48058 Republic of Korea Phone +82-51-745-7836 Fax +82-51-745-7781
Contact / US agent:
DIO USA. Peter, Kang 3470 Wilshire Blvd. #620 Los Angeles, CA Phone +1-213-365-2875 Fax +1-213-365-1595
Device Information:
Trade Name: UF(II) Anatomic 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: 09/26/2019
General Description
The UF(II) Anatomic abutment is intended to be used with the root-form endosseous dental implant to aid in prosthetic rehabilitation. The anatomic abutment has scalloped margins to follow the gingival contour to provide better esthetic results with the final prosthesis. It consist of straight abutment and angled of 5°, 18°, and are made from titanium alloy conforming to ASTM F136. The anatomic abutments are pre-manufactured (stock) abutments is provided non-sterile, this should be user steam sterilized before use.
Indication For Use
The UF(II) Anatomic abutment is intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns or bridges. The abutment can be used in single tooth replacements and multiple tooth restorations.
Predicate devices
The subject device is substantially equivalent to the following predicate and Reference Device: Primary Predicate Device : P.004 RC Anatomic Abutments (K062129) Reference Device : P.004 NC Anatomic abutment (K071357) Neodent Implant System CM Anatomic Abutment (K150199)
DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEM (K122519)
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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 "D" and "I" are 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".
Summaries of Technological Characteristics
The subject device is substantially equivalent of 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 Device | Primary
Predicate Device | Reference Device | | |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant | DIO Corporation | Institut Straumann AG | Straumann US (on behalf of
Institut Straumann AG) | JJGC Industria E Comercio
De Materiais Dentarios SA | DIO Corporation |
| Trade Name | UF(II) Anatomic
abutment | P.004 RC Anatomic
Abutments | P.004 NC Anatomic
Abutment | Neodent Implant System | DIO UF HSA INTERNAL
SUB-MERGED IMPLANT
SYSTEM |
| 510(K) No. | K190048 | K062129 | K071357 | K150199 | K122519 |
| Classification
Name | Endosseous Dental
Implant, Abutment
(872.3630) | Endosseous Dental
Implant, Abutment
(872.3630) | Endosseous Dental Implant,
Abutment
(872.3630) | Endosseous Dental Implant,
Abutment
(872.3630) | Endosseous Dental Implant,
Abutment
(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-6Al-4V ELI
(ASTM F136) | Ti-6Al-4V ELI
(ASTM F136) |
| Design | Image: UF(II) Anatomic abutment | Image: P.004 RC Anatomic Abutments | Image: P.004 NC Anatomic Abutment | Image: Neodent Implant System | Image: DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEM |
| Abutment
Diameters (mm) | 4.21/4.49/4.84/5.11/6.14 | 6.5 | 4.0 | 4.7/6.0 | 4.5/5.5 |
| | | | | | |
| Gingival heights | 1.5/2.5/3.5/4.5/5.5 | 2.0/3.5 | 2.0/3.5 | 1.5/2.5/3.5 | 1.5/2.0/3.0/4.0/5.0 |
| Angle | 5/18 | 0/15 | 0/15 | 0/17 | 15/25 |
| 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) | Steam Sterilization by user
(Delivered non sterile) |
| Type of
Retention | Screw-retained or cement
retained | Screw-retained or cement
retained | Screw-retained or cement
retained | Screw-retained or cement
retained | Screw-retained or cement
retained |
| Intended Use | The UF(II) Anatomic
abutment is intended to be
placed into dental
implants to provide
support for prosthetic
reconstructions such as
crowns or bridges. The
abutment can be used in
single tooth replacements
and multiple tooth
restorations. | The P.004 Implants are
intended for immediate,
delayed or conventional
placement in the maxilla
and/or mandibular arches
to support crowns, bridges
or overdentures in
edentulous or partially
edentulous patients.
They are intended for
immediate function on
single-tooth and/or
multiple tooth
applications when good
primary stability is
achieved and with
appropriate occlusal
loading, to restore
chewing function.
Multiple tooth
applications may be
rigidly splinted. In the
case of edentulous | Abutments are intended to be
placed into dental implants
to provide support for
prosthetic reconstructions
such as crowns, bridges and
overdentures. Abutments can
be used in single tooth
replacements and multiple
tooth restorations. | CM Alvim Acqua Implant
The Neodent Implant System
is intended to be surgically
placed in the bone of the
upper or lower jaw to
provide support for
prosthetic devices such as
artificial teeth, to restore
chewing function. It may be
used with single-stage or
two-stage procedures, for
single or multiple unit
restorations, and may be
loaded immediately when
good primary stability is
achieved and with
appropriate occlusal loading.
Multiple tooth applications
may be rigidly splinted.
Facility Acqua Implant
The Neodent Implant System
is intended to be surgically
placed in the bone of the | The DIO UF HSA Internal
Sub-Merged Implant System
is indicated for surgical
placement in the upper and
lower jaw arches, to provide
a root form means for single
or multiple unit's prosthetic
attachment to restore a
patient's chewing function.
The smaller(Ø3.8~5.5)
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 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 |
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Image /page/5/Picture/1 description: The image shows the logo for DIO Implant Solution. The logo has the letters DIO in a sans-serif font, with the DI in gray and the O in pink. There is a small pink circle above the O. Below the letters is the text "Implant Solution" in a smaller, gray font.
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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 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, the words "Implant Solution" are written in a smaller, gray font.
| | implants must be used.
Abutments are intended
to be placed into dental
implants to provide
support for prosthetic
reconstructions such as
crowns or bridges. Meso
abutments are indicated
for cemented restorations
particularly in esthetic
areas of the mouth. The
abutment can be used in
single tooth replacements
and multiple tooth
restorations. | upper or lower jaw to
provide support for
prosthetic devices such as
artificial teeth, to restore
chewing function. It may be
used with single-stage or
two-stage procedures, for
single or multiple unit
restorations, and may be
loaded immediately when
good primary stability is
achieved and with
appropriate occlusal loading.
The Facility implant is
indicated for replacement of
maxillary lateral incisors,
mandibular incisors or
retention of overdentures. | larger(Ø6.0~7.0) 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. |
|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | CM Anatomic Abutment,
Exact Anatomic, Lateral
Anatomic, and Lateral
Anatomic Abutments
The Neodent Implant System
is intended to be surgically
placed in the bone of the
upper or lower jaw to
provide support for
prosthetic devices such as
artificial teeth, to restore
chewing function. It may be
used with single-stage or
two-stage procedures, for | |
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Image /page/7/Picture/1 description: The image shows the logo for DIO Implant Solution. The letters "DIO" are in a bold, sans-serif font, with the "O" in pink and the rest in gray. Above the "O" is a small pink circle. Below the logo is the text "Implant Solution" in a smaller, gray, sans-serif font.
| | | | | single or multiple unit
restorations, and may be
loaded immediately when
good primary stability is
achieved and with
appropriate occlusal loading. | |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Substantial
Equivalence
Comparison | The UF(II) Anatomic abutment is substantially equivalent in designs, dimensions, material, indications, and technological characteristics with the
identified primary predicate device. The UF(II) Anatomic abutment is similar 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-food
endosseous dental implants and endosseous dental implant abutments.
The diameters and angulation of the subject device are slightly different from the predicate devices. However, the subject diameters and angulations are
in the range of diameters and angulation of predicates.
The Indications for Use of the subject and primary predicate device are identical other than lack of the first sentence and middle sentence for fixture. It
is acceptable since the subject device is anatomic abutment only. Therefore, the indication related to fixture was excluded. Thus, the proposed
indications do not increase risk nor change the intended use of the device and are found to be substantially equivalent.
Any differences in technology characteristics are accompanied by information that demonstrated the device is substantially equivalent as the
predicate and do not raise different questions of safety and effectiveness than the predicate. | | | | |
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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. 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 gray font, are the words "Implant Solution."
Non-clinical Testing
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. This testing included:
Sterilization Validation
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 10-6 was achieved and all testing requirements were met. Sterilization was conducted in accordance with FDA Guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling".
For the subject devices provided non-sterile status.
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
Biocompatibility
The Biocompatibility Test are leveraged from previous submission (K122519). Biocompatibility test 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". Abutments have the identical nature of body contact, contact duration, material formulation, manufacturing processes, and sterilization methods compared to the primary and reference devices. No new issues of biocompatibility are raised for the subject devices. 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".
Therefore, no additional biocompatibility testing was required.
Conclusions
The UF(II) Anatomic 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, UF(II) Anatomic abutment send its predicates are substantially equivalent.