(543 days)
No
The document describes a physical dental abutment system and its components, with no mention of software, algorithms, or any technology related to AI or ML. The performance studies focus on physical properties and compatibility.
No
The device is an SD Abutment made of Ti-6A1-4V ELI alloy and/or Pure Titanium Gr4, intended for use as an aid in single or multiple-unit prosthetic restorations. It consists of various types of abutments and abutment screws. Its stated purpose is to support prosthetic restorations in edentulous maxilla, not to treat a disease or condition or restore structure/function directly in a therapeutic manner.
No
The device description clearly states it is an abutment for prosthetic restorations, and the intended use is for supporting these restorations in edentulous maxilla. Its purpose is mechanical support and connection, not to detect, diagnose, or monitor a disease or condition.
No
The device description explicitly states it is made of Ti-6A1-4V ELI alloy and/or Pure Titanium Gr4 and consists of physical components like Healing Abutment, Solid Abutment, etc., indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the SD Abutment is a physical component (made of titanium alloy) intended for use in dental implant procedures to support prosthetic restorations in the mouth. It is a surgical and prosthetic device, not a device used for testing biological samples.
The information provided focuses on the physical properties, intended surgical use, and mechanical performance of the abutment, which are characteristic of a non-IVD medical device.
N/A
Intended Use / Indications for Use
SD Abutment is intended for use in partially or fully edentulous maxilla, in support of single or multiple-unit prosthetic restorations. SD Abutment is for single stage and two stage surgical procedures. This system is intended for delayed loading.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
SD Abutment made of Ti-6A1-4V ELI alloy (ASTM F136) and/or Pure Titanium Gr4 (ASTM F67) is intended for use as an aid in single or multiple-unit prosthetic restorations. It consists of Healing Abutment, Solid Abutment, Dual Abutment, Dual Long Abutment, Angled Abutment (15° and 25°), Temporary Abutment and Abutment Screws. All abutments are supplied non-sterile and autoclaved by the end user. The abutments are to be used with the as followed fixtures:
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
partially or fully edentulous mandibles and maxilla
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)
Physical Tests:
- 30° Compressive Loads
- Fatigue
- Adaptation Accuracy
- Torsional Breaking Force
- Removal Torque Force
- Adaptation Accuracy
- Torsional Breaking Force
- Removal Torque Force
- 30° Compressive Loads
- Fatigue
- Visual
- Dimension
- Package
Results: Equivalent to predicate devices.
Reverse Engineering tolerance analysis was conducted on the original OEM 3rd party implant body, abutment, and abutment screw to ensure compatibility of the SD Abutment.
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.)
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 17, 2019
Surgident Co., Ltd. % Peter Chung Representative Plus Global 300 Atwood Street Pittsburgh, Pennsylvania 15213
Re: K173570
Trade/Device Name: SD Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: April 17, 2019 Received: April 19, 2019
Dear Peter Chung:
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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 Malvina Eydelman, M.D. Director OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173570
Device Name SD Abutment
Indications for Use (Describe)
SD Abutment is intended for use in partially or fully edentulous maxilla, in support of single or multipleunit prosthetic restorations. SD Abutment is for single stage and two stage surgical procedures. This system is intended for delayed loading.
The SD Abutment is compatible with the following devices:
| No. | Trade Name | Platform
Diameters
(mm) | Body
Diameters
(mm) | Lengths
(mm) |
|-----|------------------------------------------|-------------------------------|---------------------------|---------------------|
| 1 | s-Clean OneQ-SL Narrow
Implant System | 03.0 | 03.0 | 10, 12, |
| | | 03.3 | 03.3 | 14 |
| 2 | OneQ-SL s-Clean Implant
System | 03.7 | 03.5 | |
| | | 03.9 | 03.6 | |
| | | 04.2 | 03.7 | 7, 8, 10,
12, 14 |
| | | 04.7 | 04.2 | |
| | | 05.2 | 04.7 | |
| | | 06.0 | 04.8 | 7, 8, 10, |
| | | 07.0 | 05.8 | 12 |
| | | 08.0 | 06.8 | |
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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3
K173570 - 510(k) Summary [as required by 807.92(c)]
1. Applicant
- a) Company: Surgident Co., Ltd.
- Address: #209~210, Woolim Lion's Valley, 27, Dunchon-daero 457beon-gil, b) Jungwon-gu, Seongnam-si, Gyeonggi-do, 13219, Korea
- +82-31-737-2875 c) Tel :
- d) Fax : +82-31-737-2876
- e) President of Company: Mr. Duck Su Hur
- f) Contact Person : Peter Chung
- Contact Person Telephone: 412-687-3976 g)
- Contact Person Address: 300, Atwood Street, Pittsburgh, PA, 15213, USA h)
- i) Preparation Date: May 17, 2019
2. Device Information
- Trade Name : SD Abutment a)
- Common Name : Endosseous Dental Implant Abutment b)
- Classification Name : c) abutment, implant, dental, endosseous
- d) Product Code : NHA
- e) Regulation Number : 872.3630
- f) Class of device : Class II
- g) Panel : Dental
3. Primary Predicate
K131682, UD Implant System / MEDIMECCA Co., Ltd.
Reference Device
K161244, s-Clean OneQ-SL Narrow Implant System, Dentis Co., Ltd. K153639, OneQ-SL s-Clean Implant System, Dentis Co., Ltd.
4. Device Description and Technological Characteristics
SD Abutment made of Ti-6A1-4V ELI alloy (ASTM F136) and/or Pure Titanium Gr4 (ASTM F67) is intended for use as an aid in single or multiple-unit prosthetic restorations. It consists of Healing Abutment, Solid Abutment, Dual Abutment, Dual Long Abutment, Angled Abutment (15° and 25°), Temporary Abutment and Abutment Screws. All abutments are supplied non-sterile and autoclaved by the end user. The abutments are to be used with the as followed fixtures:
| No. | 510k No. | Trade Name | Platform
Diameters
(mm) | Body
Diameters
(mm) | Lengths
(mm) | Manufacturer |
|-----|----------|------------------------------------------|-------------------------------|---------------------------|-----------------|---------------------|
| 1 | K161244 | s-Clean OneQ-SL Narrow
Implant System | 03.0
03.3 | 03.0
03.3 | 10, 12,
14 | Dentis Co.,
Ltd. |
| 2 | K153639 | OneQ-SL s-Clean
Implant System | 03.7
03.9
04.2 | 03.5
03.6
03.7 | 7, 8, 10, | |
4
| 04.7 | 04.2 12, 14 | |
|---|---|---|
| 05.2 | 04.7 | |
| 06.0 | 04.8 7, 8, 10, | |
| 07.0 | 05.8 12 | |
| 08.0 | 06.8 |
5. Indication for Use
SD Abutment is intended for use in partially or fully edentulous mandibles and maxilla, in support of single or multiple-unit prosthetic restorations. SD Abutment is for single stage and two stage surgical procedures. This system is intended for delayed loading.
| No. | Trade Name | Platform
Diameters
(mm) | Body
Diameters
(mm) | Lengths
(mm) |
|-----|------------------------------------------|--------------------------------------------------------------|--------------------------------------------------------------|----------------------------------------|
| 1 | s-Clean OneQ-SL Narrow
Implant System | 03.0
03.3 | 03.0
03.3 | 10, 12,
14 |
| 2 | OneQ-SL s-Clean Implant
System | 03.7
03.9
04.2
04.7
05.2
06.0
07.0
08.0 | 03.5
03.6
03.7
04.2
04.7
04.8
05.8
06.8 | 7, 8, 10,
12, 14
7, 8, 10,
12 |
The SD Abutment is compatible with the following devices:
6. Performance Data
- a) Physical Tests
| No. | Test items | Results |
|---|---|---|
| 1. | 30° Compressive Loads | |
| 2. | Fatigue | |
| 3. | Adaptation Accuracy | |
| 4. | Torsional Breaking Force | |
| 5. | Removal Torque Force | |
| 6. | Adaptation Accuracy | |
| 7. | Torsional Breaking Force | Equivalent to predicate devices |
| 8. | Removal Torque Force | |
| 9. | 30° Compressive Loads | |
| 10. | Fatigue | |
| 11. | Visual | |
| 12. | Dimension | |
| 13. | Package |
Reverse Engineering tolerance analysis was conducted on the original OEM 3rd party implant body, abutment, and abutment screw to ensure compatibility of the SD Abutment.
5
7. Predicate Device Comparison Table
The SD Abutment is substantially equivalent to previously marketed devices. The design features and sizing of the components were compared and the SD Abutment found to be substantially equivalent as the predicate device. The primary predicate includes a list of examples for single and multiple unit restorations whereas the subject device contains this information in the labeling for each specific abutment. Additionally, the primary predicate is dental abutments for the predicates own implant bodies whereas the subject device is a 30 party abutment compatible. The inclusion of the specific compatible implant bodies, while different as compared to the primary predicate's Indications for Use, is necessary to adequately identify the indications for the subject device and the appropriate patient population. There are no significant differences between the SD Abutment and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to other devices in design, function, material and intended use.
| | | SUBJECT Device | Primary PREDICATE Device
K131682 | | | | | | | | | | | | | | | | | | | | | |
|---------------------|------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | | Surgident Co., Ltd. | MEDIMECCA Co., Ltd. | | | | | | | | | | | | | | | | | | | | | |
| Common Name | | Endosseous Dental Implant
Abutment | Endosseous Dental
Implant | | | | | | | | | | | | | | | | | | | | | |
| Trade Name | | SD Abutment | UD Implant System | | | | | | | | | | | | | | | | | | | | | |
| Indications for Use | | SD Abutment is intended for use in
partially or fully edentulous mandibles and
maxilla, in support of single or multiple-
unit prosthetic restorations. SD Abutment
is for single stage and two stage surgical
procedures. This system is intended for
delayed loading. The SD Abutment is
compatible with the following devices:
No. 510k No. Trade Name Platform Diameters
(mm) Body Diameters
(mm) Lengths
(mm) Manufacturer 1 K161244 s-Clean OneQ-SL
Narrow Implant System 03.0
03.3 03.0
03.3 10, 12,
14 Dentis Co.,
Ltd. 2 K153639 OneQ-SL s-Clean
Implant System 03.7
03.9
04.2
04.7
05.2
06.0
07.0
08.0 03.5
03.6
03.7
04.2
04.7
04.8
05.8
06.8 7, 8, 10,
12, 14 | | | | | | | | | | | | | | | | | | | | | | UD Implant System
intended for use in
partially or fully
edentulous mandibles and
maxilla, in support of
single of multiple-unit
restorations
including: cemented
retained, screw retained,
or overdenture
restorations, and
terminal or
intermediate abutment
support for fixed
bridgework. UD
Implant System is for
single stage and two
stage surgical
procedures.
This
system is
intended for delayed
lading. |
| Components | | Abutments | Fixtures and abutments | | | | | | | | | | | | | | | | | | | | | |
| Healing | Type | Internal | Internal | | | | | | | | | | | | | | | | | | | | | |
6
| Abutment | Diameter (mm) | ||||
|---|---|---|---|---|---|
| 4.0 mm, 4.5 mm, 5.0 mm, 5.5 mm, 6.0 mm, 6.5 mm, 7.5 mm, 8.5 mm | 4.0 mm, 4.5 mm, 5.5 mm, 6.5 mm | ||||
| Solid Abutment | Type | Internal | Internal | ||
| Diameter (mm) | 4.0 mm, 4.5 mm, 5.0 mm, 5.5 mm, 6.0 mm, 6.5 mm | 4.0 mm, 4.5 mm, 5.5 mm, 6.5 mm | |||
| Dual Abutment | Type | Internal Hex, Internal Non-Hex | Internal Hex, Internal Non-Hex | ||
| Diameter (mm) | 4.0 mm, 4.5 mm, 5.0 mm, 5.5 mm, 6.0 mm, 6.5 mm | 4.0 mm, 4.5 mm, 5.5 mm, 6.5 mm | |||
| Dual Long Abutment | Type | Internal Hex, Internal Non-Hex | Internal Hex, Internal Non-Hex | ||
| Diameter (mm) | 4.0 mm, 4.5 mm, 5.0 mm, 5.5 mm, 6.0 mm, 6.5 mm | 4.0 mm, 4.5 mm, 5.5 mm, 6.5 mm | |||
| Angled Abutment | Type | Internal Hex, Internal Non-Hex | Internal Hex, Internal Non-Hex | ||
| Diameter (mm) | 4.0 mm, 4.5 mm, 5.0 mm, 5.5 mm, 6.0 mm, 6.5mm | 4.5 mm, 5.5 mm | |||
| Angulation | 15°, 25° | 15°, 25° | |||
| Temporary Abutment | Type | Internal Hex, Internal Non-Hex | Internal Hex, Internal Non-Hex | ||
| Diameter (mm) | 4.0 mm, 4.5 mm, 5.0 mm, 5.5 mm, 6.0 mm, 6.5 mm | 4.0 mm, 4.5 mm | |||
| Material | Ti-6Al-4V ELI (ASTM F136), or Titanium Grade 4 (ASTM F67) | Ti-6Al-4V ELI (ASTM F136), or Titanium Grade 4 (ASTM F67) | |||
| Physical testing performed | Test according to ISO 14801 | Test according to ISO 14801 | |||
| Biocompatibility | Biocompatible according to ISO 10993-1 (evaluated cytotoxicity, sensitization, irritation, acute systemic toxicity, genotoxicity, implantation) | Biocompatible according to ISO 10993-1 | |||
| Single Use | yes | yes | |||
| Sterilization method | The abutment is supplied non-sterile (Steam sterilization prior to use). Validation via ISO 17665-1 & ISO 17665-2 | Gamma radiation |
8. Conclusion
The SD 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-form endosseous dental implants and endosseous dental implant abutments".
The subject device and the predicate device have the same intended use and have the same technological characteristics. The subject and predicate implants are all made of the titanium
7
alloys and have not the surface treatments. The subject and the predicate devices encompass the similar range of physical dimensions, including diameter and length of the implants. and diameter of the abutments.
Overall, the SD Abutment has the following similarities to the predicate device:
- . has the same intended use.
- uses the same operating principle. .
- . incorporates the same basic design.
- . incorporates the same material.
Based on the similarities, we conclude that the SD Abutment is substantially equivalent to the predicate device.