(163 days)
No
The summary describes standard dental prosthetic components and their performance testing, with no mention of AI or ML.
No.
The device is described as an "aid in prosthetic rehabilitation," which are components for dental prosthetics. While these prosthetics serve a restorative purpose, the device itself (abutments) is not directly used for curing, treating, or preventing a disease or condition in the therapeutic sense.
No
The device is described as an aid in prosthetic rehabilitation, consisting of abutments for dental implants. Its intended use focuses on providing support for prosthetics rather than identifying or assessing a medical condition. Performance studies mentioned are related to biocompatibility and mechanical properties, not diagnostic accuracy.
No
The device description explicitly states that the device consists of physical components (abutments, cover screw, screw abutment cylinders) made of materials that undergo biocompatibility and bench testing. It is not solely software.
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 directly on or in the patient for a therapeutic or restorative purpose, not for testing samples outside the body to diagnose or monitor a condition.
- Device Description: The device is described as "Abutments," which are components used in dental implants to connect the implant to the prosthetic tooth. This is a physical device used in a surgical and restorative procedure.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The performance studies mentioned (biocompatibility and bench testing) are relevant to the safety and mechanical performance of a medical device intended for implantation and prosthetic use, not for diagnostic testing.
N/A
Intended Use / Indications for Use
Dentium Prosthetics are intended for use as an aid in prosthetic rehabilitation.
Product codes
NHA
Device Description
Dentium Implantium and SuperLine Abutments are intended for use an aid in prosthetic rehabilitation. The abutments were originally cleared under 510(k) K041358. The modified designs proposed in this submission consist of the Angled Screw Abutment, Cover Screw, and Screw Abutment Cylinders. 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
Biocompatibility testing:
-ISO Cytotoxicity
-ISO Systemic toxicity
-ISO Pyrogenicity
-ISO Sensitization
-ISO Intracutaneous reactivity
Performance bench testing:
-ISO Static compressive
-ISO Fatigue
-Corrosion Testing
-Adaptation Accuracy
-Modified Surface
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 fatigue limit and passed 5,000,000 cycles.
Key Metrics
Not Found
Predicate Device(s)
K041368, K052823, K052957, K112045
Reference Device(s)
Not Found
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 depiction of a human figure in profile, with three overlapping faces suggesting community and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 12,2014
Dentium Company Limited C/O Ms. Sheryl Higgins US Agent 6761 Katella Avenue Cypress, CA 90630
Re: K141457
Trade/Device Name: Dentium Implantium® and SuperLine® Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: October 14, 2014 Received: October 15, 2014
Dear Ms. Higgins:
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 - Ms. Higgins
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
Susan Runno, DDS, mA
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number: K141457
Dentium Implantium® / SuperLine® Abutments Device Name:
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)
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510(k) Summary
1. Company
| Submitter | |
|---|---|
| Name | Dentium Co., Ltd. |
| Address | 440, Changnyong-daero, lui-dong, Yeongtong-gu, Suwon-si, |
| Gyeonggi-do, Korea, 443-270 | |
| Phone / Fax | +82 31 207 2200 / +82 31 207 3883 |
| Contact person | Sheryl Higgins / US Agent |
| 714-226-0229 x107 | |
| shiggins@dentiumusa.com |
2. Device Name
| Proprietary name: | Dentium Implantium® / SuperLine® Abutments |
|---|---|
| Common name: | Abutment, Prosthetic Device |
| Classification name: | Abutment, Implant, Dental, Endosseous |
| NHA, 21 CFR 872.3630 |
3. Predicated Device
K041368 - Dentium Co. Ltd., Implantium K052823 - Implantium Abutments K052957 - Implantium Prosthetics K112045 - SimpleLine II Abutment System
4. Description
Dentium Implantium and SuperLine Abutments are intended for use an aid in prosthetic rehabilitation. The abutments were originally cleared under 510(k) K041358. The modified designs proposed in this submission consist of the
COMPANY CONFIDENTIAL
4
Angled Screw Abutment, Cover Screw, and Screw Abutment Cylinders. Abutments are supplied non-sterile and autoclaved by the end user.
| Name | Class | Material | Dia
(mm) | G/H
(mm) | Connection | Angle | Figure | Model Number |
|-----------------------------|-------|---------------------------------------------------------------|------------------|------------------|--------------------|------------------|------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Angled
Screw
Abutment | II | Pure Ti-G4
(ASTM F67)
TiN Coated | 4.5
to
5.5 | 1.0
to
1.5 | Hex and
Non-hex | 15°
to
30° | Image: Angled screw abutment | ASA45151018H
ASA45151018N
ASA45301018H
ASA45301018N
ASA55151518H
ASA55151518N
ASA55301518H
ASA55301518N |
| Screw | II | Ti-6Al-4V ELI
alloy
(ASTM F136) | 1.8
to
2.3 | n/a | n/a | n/a | Image: Screw | ASASC2023
SRS18T |
| Cover
Screw | II | Ti-6Al-4V ELI
alloy
(ASTM F136)
Annozided | 3.6 | n/a | n/a | n/a | Image: Cover screw | CS36 |
| Cylinder -
Titanium | II | Pure Titanium,
Grade 2
(ASTM F67-00) | 4.5
to
5.5 | n/a | Hex and
Non-hex | n/a | Image: Titanium cylinder | STC45SG
STC45BG
STC55SG
STC55BG |
| Cylinder -
Gold | II | Gold Alloy | 4.5
to
5.5 | n/a | Hex and
Non-hex | n/a | Image: Gold cylinder | SGC45SL
SGC45BL
SGC55SL
SGC55BL |
| Cylinder -
Metal | II | Cobalt-28
Chromium-6
Molybdenum
Alloy (ASTM
F799) | 4.5
to
5.5 | n/a | Hex and
Non-hex | n/a | Image: Metal cylinder | SGC45CSL
SGC45CBL
SGC55CSL
SGC55CBL |
5
5. Indication for Use
Dentium Prosthetics are intended for use as an aid in prosthetic rehabilitation.
6. Identification of the Risk
Risk analysis was performed according to ISO 14971:2007, "Medical devices - Application of risk management to medical devices". All risks identified have been mitigated and any residual risk is within acceptable levels.
7. Device Characteristics
Dentium Implantium / SuperLine Abutments are supplied in many different shapes and sizes to meet the patient specific needs of our customers. All abutment are made with Dentium's universal conical connection so that thev securely mate with any Dentium Implantium / SuperLine Fixture.
8. Performance Testing
Biocompatibility testing on the proposed Implantium & SuperLine Abutments have been completed. Requirements for biological evaluation of the purposed device were based on the ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." The biocompatibility test results show that the materials used in the design and manufacture of the components of the proposed device are nontoxic and non-sensitizing to biological tissues consistent with its intended use. The following biocompatibility tests were completed:
| -ISO Cytotoxicity | -ISO Systemic toxicity |
|---|---|
| -ISO Pyrogenicity | -ISO Sensitization |
| -ISO Intracutaneous reactivity |
The proposed Implantium & SuperLine Abutments were evaluated using the following performance bench testing to confirm the performance characteristics:
| -ISO Static compressive | -ISO Fatigue |
|---|---|
| -Corrosion Testing | -Adaptation Accuracy |
| -Modified Surface |
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 fatigue limit and passed 5,000,000 cycles.
COMPANY CONFIDENTIAL
6
9. Reliance on Standards
All testing was performed in compliance with Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments.
10. Review
All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Implantium & SuperLine Abutments meet the established specifications necessary for consistent performance according to its intended use.
Implantium & SuperLine Abutments have been subjected to safety, performance, and product validations prior to release. Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations.
11. 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 Implantium & SuperLine Abutments are substantially equivalent to the predicate device.