(112 days)
No
The summary describes a dental implant made of titanium with different surface treatments and shapes. There is no mention of AI or ML technology in the intended use, device description, or any of the other sections.
Yes
The device is intended to restore the patient's chewing function, which is a therapeutic purpose.
No
The device is a dental implant used for supporting prosthetic devices and restoring chewing function, not for diagnosing conditions.
No
The device description clearly states it is a dental fixture made of pure titanium metal intended for surgical placement, indicating it is a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The Implantium II is a dental implant, a physical device surgically placed in the bone. It does not analyze biological specimens.
- Intended Use: The intended use is to provide structural support for prosthetics and restore chewing function, which is a mechanical and functional purpose, not a diagnostic one.
Therefore, based on the provided information, the Implantium II is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Implantium II is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetics devices, such as artificial teeth, and to restore the patient's chewing function. Implantium II are for single stage or two stage surgery.
Product codes
DZE
Device Description
The Implantium II is a dental fixture made of pure titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches.
The Implantium II is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The differences between them are shape and surface. The Implantium II has one-stage and two-stage surgery. The Implantium II has S.L.A. or Anodizing surface while Implantium has S.L.A (Sand-blasted Large grit Acid-etched).
The Implantium II is substantially equivalent in design, function and intended use to the fixtures of Dentium Co., Ltd. Implantium.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone of the upper or lower jaw 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)
Not Found
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.
0
27-5 Leui-Dong, Yeongtong-Gu, Suwon-Si, Gyeonggi-Do, Korea 442-270 | Demtitul m
Tel 82 31 207-2200 Fax 82 31 207-3933 Tel 82 31 207-2200 Fax 82 31 207-3933
Dentium
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
JUN 16 2006
Date: February 10, 2006
- Company and Correspondent making the submission: 1.
| Company | |
|---|---|
| Name | Dentium Co., Ltd. |
| Address | 27-5 Leui-Dong, Yeongtong-Gu, |
| Suwon-Si, Gyeonggi-Do, Korea 442-270 | |
| Phone | |
| Fax | |
| Contact | +82 31 207-2200 |
| +82 31 207-3933 | |
| K. Y. Yoon |
-
- Device: Proprietary Name - Implantium II Common Name - Dental Implant Classification Name - Endosseous dental implant
-
- Predicate Device: Implantium, Dentium Co., Ltd., K041368
- Classifications Names & Citations: 4. 21CFR 872.3640, DZE, Endosseous dental implant, Class2
- న్. Description:
The Implantium II is a dental fixture made of pure titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches.
The Implantium II is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The differences between them are shape and surface. The Implantium II has one-stage and two-stage surgery. The Implantium II has S.L.A. or Anodizing surface while Implantium has S.L.A (Sand-blasted Large grit Acid-etched).
The Implantium II is substantially equivalent in design, function and intended use to
Page I of 2
0000 10
1
27-5 Leui-Dong, Yeongtong-Gu, Suwon-Si, Gyeonggi-Do, Korea 442-270 Tel 82 31 207-2200 Fax 82 31 207-3933
| Dentium
the fixtures of Dentium Co., Ltd. Implantium.
-
- Indication for use:
Implantium II is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetics devices, such as artificial teeth, and to restore the patient's chewing function.
- Indication for use:
-
- Review:
Implantium II has the same device characteristics as the predicate device. Material, design and use concept is similar.
- Review:
-
- Conclusions:
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification Dentium Co., Ltd. concludes that Implantium II is safe and effective and substantially equivalent to predicate devices as described herein.
- Conclusions:
2
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract image of an eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
JUN 16 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dentium Company, Limited C/O Ms. Cathryn N. Cambria President Arkin Consulting Group 5536 Trowbridge Drive Dunwoody, Georgia 30338
Re: K060501
Trade/Device Name: Implantium II Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: June 13, 2006 Received: June 14, 2006
Dear Ms. Cambria:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2 - Ms. Cambria
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address . http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Clues
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number K206050
Implantium II Device Name:
Indication for use: Implantium II is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetics devices, such as artificial teeth, and to restore the patient's chewing function. Implantium II are for single stage or two stage surgery.
Prescription Use______________________________________________________________________________________________________________________________________________________________ OR (Per 21CFR801 Subpart D)
Over-The-Counter Use (Per 21CFR807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suen Kuan
າ ວ່າ Anesthesiology, General Hospital, on Control, Dental Devices
Number K6(050)
0000003