(263 days)
Not Found
No
The summary describes a physical dental implant and its materials, dimensions, and testing. There is no mention of software, algorithms, or any technology that would suggest AI/ML.
Yes
The device is intended to serve as temporary support for a provisional prosthetic device during the healing phase of permanent endosseous dental implants, indicating a therapeutic purpose.
No
The device is described as a mini implant intended for temporary support of provisional prosthetic devices during the healing phase of permanent endosseous dental implants, indicating a therapeutic or supportive function rather than a diagnostic one.
No
The device description clearly states it is a "mini implant made of Ti-6A1-4V ELI alloy(ASTM F136) and Pure Titanium Gr4(ASTM F67)" and describes its physical characteristics (diameter, length, surface treatment). This indicates a physical hardware device, not software only.
Based on the provided information, 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.
- Device Description and Intended Use: The Slim Onebody System is a physical implant designed to be surgically placed in the jawbone (mandibles and maxillae) to support temporary dental prosthetics. It is a medical device used in vivo (within the body), not a test performed in vitro (outside the body).
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of biomarkers, or diagnostic purposes.
Therefore, the Slim Onebody System is a dental implant, which is a type of medical device, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Slim Onebody System is intended for immediate loading in partially or fully edentulous mandibles and maxillae to serve as temporary support for provisional prosthetic device during the healing phase (maximum six months) of permanent endosseous dental implants.
Product codes
DZE
Device Description
The Slim Onebody System is a mini implant made of Ti-6A1-4V ELI alloy(ASTM F136) and Pure Titanium Gr4(ASTM F67). It serves as a temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implantation. Its surface is S.L.A(Sand-Blasted, Large Grit, Acid-etched). It is comprised of diameter ranging from 2.0 - 3.0mm and lengths ranging from 10mm -14mm. The product consists of a FIX type and a Ball Type implant.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandibles and maxillae
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical test data was used to support the decision of safety and effectiveness. Non-clinical testing consisted of performance of fatigue testing in accordance with the FDA guidance Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments.
Biocompatibility testing on the proposed Slim Onebody System has been completed. Requirements for biological evaluation of the proposed device were based on the ISO7405 (2008), "Dentistry-Evaluation of biocompatibility of medical devices used in dentistry." The biocompatibility test results show that the materials used in the design and manufacture of the components of the proposed device are non-toxic and non-sensitizing to biological tissues consistent with its intended use. The following biocompatibility tests were completed:
-ISO Cytotoxicity
-ISO Pyrogenicity
-ISO Intracutaneous reactivity
-ISO Systemic toxicity
-ISO Sensitization
-ISO Irritation
The proposed Slim Onebody System was evaluated using the following performance bench testing to confirm the performance characteristics:
-ISO Fatigue
-ISO Static compressive
--Torque Force
The testing indicates that the device is strong enough to withstand the anticipated forces.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
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JAN 1 3 2012
510(k) Summary
12/14/2011
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part 807.92.
1. Company
| Submitter | Official Correspondent | |
|---|---|---|
| Name | Dentium Co., Ltd. | Dentium USA |
| Address | 27-5 Iui-dong, Yeongtong-gu, | |
| Suwon-si, Gyeonggi-do, 443-766, | ||
| Korea | 6761 Katella Avenue Cypress, CA | |
| 90630, USA | ||
| Phone | +82-31-207-2200 | 714-226-0229 |
| Fax | +82-31-207-3883 | 714-226-0019 |
| Contact person | Lee, Sungwon / R&D | |
| swlee(@dentium.com) | Eunkyung Son / Doctor | |
| json@dentiumusa.com |
2. Device Name
| Proprietary name: | Slim Onebody System |
|---|---|
| Common name: | Endosseous Dental Implant |
| Classification name: | Implant, Endosseous, Root-Form |
| Product Code: | DZE |
| Regulation Number: | 21CFR872.3640 |
| Device Class: | Class II |
3. Predicated Device
IMTEC, Sendax MDI and MDI Plus K031106
4. Description
The Slim Onebody System is a mini implant made of Ti-6A1-4V ELI alloy(ASTM F136) and Pure Titanium Gr4(ASTM F67). It serves as a temporary support for provisional prosthetic device during the healing phase of permanent endosseous
510(k) Summary.
Page 1 of 4
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dental implantation. Its surface is S.L.A(Sand-Blasted, Large Grit, Acid-etched). It is comprised of diameter ranging from 2.0 - 3.0mm and lengths ranging from 10mm -14mm. The product consists of a FIX type and a Ball Type implant.
5. Substantial Equivalence
| Trade name | Slim Onebody System | Sendax MDI |
|---|---|---|
| Manufacturer | Dentium Co., Ltd. | IMTEC(SENDAX) |
| 510(k) | New device | K031106 |
| Materials | Titanium Alloy | Titanium, Titanium Alloy |
| Form | Root-Form, Threaded | Root-Form, Threaded |
| Sterilization | Sterile | Sterile |
| Length | 10mm~14mm | 10mm~18mm |
| Diameter | 2.0~ 3.0 | 1.8 ~ 2.4 |
| Indications | ||
| for use | The Slim Onebody System is | |
| intended for immediate loading in | ||
| partially or fully edentulous | ||
| mandibles and maxillae to serve | ||
| as temporary support for | ||
| provisional prosthetic device | ||
| during the healing phase | ||
| (maximum six months) of | ||
| permanent endosseous dental | ||
| implants. | The MDI and MDI PLUS are | |
| self-tapping titanium thread | ||
| screws indicated for long-term | ||
| intra-bony applications. | ||
| Additionally, the MDI may also | ||
| be used for inter-radicular | ||
| transitional applications. | ||
| These devices will permit | ||
| immediate splinting stability and | ||
| long-term fixation of new or | ||
| existing crown and bridge | ||
| installations, for full partial | ||
| endentulism, and employing | ||
| minimally invasive surgical | ||
| Use | Prescription | intervention. |
| Prescription |
Raw material, mechanical and physical properties, shape, and intended use are similar to the predicated devices. The differences between Slim Onebody and predicate devices are the slight mechanical and physical characteristics. However, the slight differences do not affect the application of the device. Therefore, we state that Slim Onebody is substantial equal with the predicate devices.
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6. Indication for Use
The Slim Onebody System is intended for immediate loading in partially or fully edentulous mandibles and maxillae to serve as temporary support for provisional prosthetic device during the healing phase (maximum six months) of permanent endosseous dental implants.
7. Non-Clinical Testing
Non-clinical test data was used to support the decision of safety and effectiveness. Non-clinical testing consisted of performance of fatigue testing in accordance with the FDA guidance Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments.
Biocompatibility testing on the proposed Slim Onebody System has been completed. Requirements for biological evaluation of the proposed device were based on the ISO7405 (2008), "Dentistry-Evaluation of biocompatibility of medical devices used in dentistry." The biocompatibility test results show that the materials used in the design and manufacture of the components of the proposed device are non-toxic 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 | -ISO Irritation |
stemic toxicity nsitization plantation
The proposed Slim Onebody System was evaluated using the following performance bench testing to confirm the performance characteristics:
-ISO Fatigue -ISO Static compressive - --Torque Force
The testing indicates that the device is strong enough to withstand the anticipated forces
8. Clinical Testing
3
Dentir
Non-clinical test data was used to support the decision of safety and effectiveness.
9. Review
All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Slim Onebody System met the established specifications necessary for consistent performance according to its intended use.
Slim Onebody System has 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.
10. Conclusions
All of the data consistent with the recommendations in the FDA guidance document Root-form Endosseous Dental Implants testing of the implants demonstrated that the Slim Onebody System is substantially equivalent to the predicate device implant.
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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Dentium Company, Limited C/O Dr. Eunkyung Son Dentium USA 6761 Katella Avenue Cypress Cypress, California 90630
JAN 1 3 2012
Re: K11162
Trade/Device Name: Slim Onebody System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: DZE Dated: December 20, 2011 Received: December 21, 2011
Dear Dr. Son:
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 Eederal Register.
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Page 2 - Dr. Son
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 ( very and suitements 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,
Wh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
k11162 510(k) Number:
Slim Onebody System Device Name:
Indications for Use:
The Slim Onebody System is intended for immediate loading in partially or fully edentulous mandibles and maxillae to serve as temporary support for provisional prosthetic device during the healing phase (maximum six months) of permanent endosseous dental implants.
V Prescription Use (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)
Susan Penner
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K111162
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