(165 days)
No
The device description and performance studies focus on the physical properties and mechanical testing of dental abutments and cylinders, with no mention of AI or ML.
No
The device is described as a component of a dental implant abutment used in the fabrication process, and not as a device directly providing therapy.
No
The document describes dental prosthetics (burn-out cylinders and angled screw abutments) used in prosthetic rehabilitation, not for diagnosing a condition.
No
The device description clearly details physical components made of PMMA and titanium, which are hardware. The performance studies also focus on mechanical testing of these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as an aid in prosthetic rehabilitation." This describes a device used in the process of restoring dental function and aesthetics, not for diagnosing a condition.
- Device Description: The description details components used in the fabrication of dental abutments and prosthetic restorations. These are physical components used in a dental procedure.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (blood, urine, tissue, etc.) or to provide information for the diagnosis of a disease or condition.
- Performance Studies: The performance studies focus on mechanical properties like fatigue strength and static load failure, which are relevant to the structural integrity of a dental prosthetic component, not diagnostic accuracy.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
Dentium Prosthetics are intended for use as an aid in prosthetic rehabilitation.
Product codes
NHA
Device Description
Burn-out Cylinder is a component of a dental implant abutment used in the process of fabricating the dental abutment and the prosthetic restoration. The Burn-out Cylinders are modified by the dental lab and incorporated into the wax framework pattern which is cast into a final gold alloy form. Burn-out Cylinder is made with PMMA (Poly(Methyl Methacrylate)) and is available in three cylinder diameters (4.5mm, 5.5mm and 6.5mm) with two connection designs (Hex and Non-Hex).
Angled Screw Abutment is a dental abutment intended for multi-unit loaded restorations and combined with the burn-out cylinder for increasing the post height to be 4mm at minimum when used for single-unit loading. Angled Screw Abutment is fabricated from Grade 4 pure titanium and partially TiN coated. Angled Screw Abutments in this submission are available in three connection designs (Hex, Long Hex and Non-Hex), two diameters (4.5mm and 5.5mm) and two angulations (15° and 30°). The Dentium angled screw abutments were originally cleared under 510(k) K141457. All subject device abutments are compatible with Implantium dental implants of Dentium Co., Ltd. Abutments are supplied non-sterile and autoclaved by the end user.
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
Prescription Use
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
Non-clinical testing was performed 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, through Reliability Calculation and Testing, as well as Fatigue Strength Testing and Static Load Failure Testing.
The proposed combination of the Angled Screw Abutment and Burn-out Cylinder was evaluated using the following performance bench testing to confirm the performance characteristics:
-ISO Fatigue: ISO 14801:2007
Static Compressive mean and Fatigue Limit were evaluated per ISO 14801. Fracture or cracks or severe distortion of any parts were not detected at the fatique limit and passed 5,000,000 cycles.
Biocompatibility and sterility of the subject device is demonstrated by testing included in the previously cleared primary predicate K141457.
Key Metrics
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.)
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 5, 2016
Dentium Co., Ltd % Younjung Yuk US Agent Dentium USA 6761 Katella Ave Cypress. California 90630
Re: K160483
Trade/Device Name: Burn-out Cylinder and Angled Screw Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: July 6, 2016 Received: July 7, 2016
Dear Younjung Yuk:
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. 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
Page 2 - Younjung Yuk
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina
Kiang -S
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number: K160483
Device Name: Burn-out Cylinder and Angled screw Abutments
Indications for Use:
Dentium Prosthetics are intended for use as an aid in prosthetic rehabilitation.
Prescription Use 区 (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use □ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
K160483
510(k) Summary
Date: August 5, 2016
1. Company
| Submitter | |
|---|---|
| Name | Dentium Co., Ltd. |
| Address | 150, Eondong-ro, Giheung-gu, Youngin-si, Gyeonggi-do, 446- |
| 914, Korea | |
| Phone / Fax | +82 31 207 2200 / +82 31 207 3883 |
| Contact person | Sangpil Yoon |
| spyoon@dentium.com |
2. Device Name
Trade / Proprietary name: Burn-out Cylinder and Angled Screw Abutments
| Common name: | Abutment, Prosthetic Device, Prosthetic
Accessories to Dental Implant |
|----------------------|--------------------------------------------------------------------------|
| Classification name: | Endosseous dental implant abutment |
| Regulation number: | 21 CFR 872.3630 |
| Class: | II |
| Panel: | Dental |
| Product code: | NHA |
3. Predicate Device
- Primary Predicate for Angled Screw Abutment K141457 - Dentium Implantium® and SuperLine® Abutments
- Reference Device for Burn-out Cylinder K990342 - Staumann SynOcta Prosthetics®
4
4. Description
Burn-out Cylinder is a component of a dental implant abutment used in the process of fabricating the dental abutment and the prosthetic restoration. The Burn-out Cylinders are modified by the dental lab and incorporated into the wax framework pattern which is cast into a final gold alloy form. Burn-out Cylinder is made with PMMA (Poly(Methyl Methacrylate)) and is available in three cylinder diameters (4.5mm, 5.5mm and 6.5mm) with two connection designs (Hex and Non-Hex).
Angled Screw Abutment is a dental abutment intended for multi-unit loaded restorations and combined with the burn-out cylinder for increasing the post height to be 4mm at minimum when used for single-unit loading. Angled Screw Abutment is fabricated from Grade 4 pure titanium and partially TiN coated. Angled Screw Abutments in this submission are available in three connection designs (Hex, Long Hex and Non-Hex), two diameters (4.5mm and 5.5mm) and two angulations (15° and 30°). The Dentium angled screw abutments were originally cleared under 510(k) K141457. All subject device abutments are compatible with Implantium dental implants of Dentium Co., Ltd. Abutments are supplied non-sterile and autoclaved by the end user.
5. Indication for Use
Dentium Prosthetics are intended for use as an aid in prosthetic rehabilitation.
6. Substantial Equivalence
| | Angled Screw Abutment
(Subject Device) | Dentium Implantium® /
SuperLine® Abutments
(Primary Predicate) | Similarities
/
Differences
of Devices |
|------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|------------------------------------------------|
| Company
Name | Dentium Co., Ltd. | Dentium Co., Ltd. | Same |
| 510(k)
Number | New Device | K141457 | - |
| Indications
for use | Dentium Prosthetics are
intended for use as an aid in
prosthetic rehabilitation. | Dentium Prosthetics are
intended for use as an aid in
prosthetic rehabilitation. | Same |
| Materials | Pure Ti-G4 (ASTM F67) | Pure Ti-G4 (ASTM F67) | Same |
| Shape | Image: Angled Screw Abutment | Image: Dentium Implantium® / SuperLine® Abutments | Same |
- Angled Screw Abutment
5
| Angle | 15° to 30° | 15° to 30° | Same |
|---|---|---|---|
| Length | 7.4 to 9.4mm | 6.4 to 7.87mm | Slight difference |
| Length | |||
| Diameter | 4.5 to 5.5mm | 4.5 to 5.5mm | Same |
| Gingiva | |||
| Height | |||
| (G/H) | 2.0 to 3.0mm | 1.0 to 1.5mm | Slight difference |
| Gingiva Height | |||
| Coating | TiN coated | TiN coated | Same |
| Use | Prescription | Prescription | Same |
| - Burn-out Cylinder | |||
|---|---|---|---|
| Burn-out Cylinder | |||
| (Subject Device) | SynOcta Prosthetics® | Similarities / | |
| Differences of Devices | |||
| Company Name | Dentium Co., Ltd. | Staumann | - |
| 510(k) Number | New Device | K990342 | - |
| Indications for use | Burn-out Cylinders are | ||
| intended for use as an aid in | |||
| prosthetic rehabilitation. | The prosthetic accessories to | ||
| dental implants are used | |||
| either in the process of | |||
| fabricating the prosthetic | |||
| restoration for the implant or | |||
| as part of the prosthetic | |||
| restoration. | Same | ||
| Materials | PMMA | PMMA | Same |
| Shape | Image: Burn-out Cylinder | Image: SynOcta Prosthetics | Slight difference |
| Shape | |||
| Length | 12mm | 10mm | Slight difference |
| Length | |||
| Diameter | 4.5~6.5mm | 4.8~6.5mm | Slight difference |
| Diameter | |||
| Use | Prescription | Prescription | Same |
Raw material, mechanical and physical properties, shape, and intended use are similar to the predicated devices. The differences between Dentium Angled screw abutments and Burn-out cylinder (subject device) and predicate devices are different from the slight mechanical and physical characteristics. However, the slight differences do not affect the application
510k Summary
COMPANY CONFIDENTIAL
6
of the device. Therefore, we state that Burn-out Cylinder and Angled Screw Abutment are substantial equivalent with the predicate devices.
7. Identification of the Risk
Risk analysis was performed according to Guidance for Industry and FDA staff - Class II Special Controls Guidance Document:Root-form Endosseous Dental Implants and Endosseous Dental Abutments issued on May 12, 2004 and ISO 14971:2007, "Medical devices - Application of risk management to medical devices". All risks identified have been mitigated based on performance testing results and any residual risk is within acceptable levels.
8. Device Characteristics
Burn-out Cylinder is fabricated from PMMA (Poly(Methyl Methacrylate)) and is available in three cylinder diameters (4.5mm, 5.5mm and 6.5mm) with two connection designs (Hex and Non-Hex).
Angled Screw Abutment is fabricated from Grade 4 pure titanium and partially TiN coated. Angled Screw Abutments in this submission are available in three connection designs (Hex, Long Hex and Non-Hex), two diameters (4.5mm and 5.5mm) and two angulations (15° and 30°). All abutments are made with Dentium's universal conical connection so that they securely mate with any Dentium Implantium® Fixtures.
9. Performance Testing
Non-clinical testing was performed 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, through Reliability Calculation and Testing, as well as Fatigue Strength Testing and Static Load Failure Testing.
The proposed combination of the Angled Screw Abutment and Burn-out Cylinder was evaluated using the following performance bench testing to confirm the performance characteristics:
-ISO Fatigue: ISO 14801:2007
7
Static Compressive mean and Fatigue Limit were evaluated per ISO 14801. Fracture or cracks or severe distortion of any parts were not detected at the fatique limit and passed 5,000,000 cycles.
Biocompatibility and sterility of the subject device is demonstrated by testing included in the previously cleared primary predicate K141457.
10. Conclusions
All of the data consistent with the recommendations in the FDA guidance document Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments demonstrated that the Dentium Angled Screw abutment and Burn-out Cylinder are substantially equivalent to the predicate device.