(279 days)
Not Found
No
The device description focuses solely on the materials and components of the prosthetic device, with no mention of software, algorithms, or any technology that would suggest AI/ML. The performance studies section mentions safety and performance validations but does not describe any studies related to AI/ML model performance.
No
The device is used as an "aid" in prosthetic rehabilitation, suggesting a supportive rather than primary therapeutic role. Therapeutic devices typically directly treat or cure a condition, whereas this device facilitates a rehabilitation process.
No
Explanation: The "Intended Use" states that Implantium Prosthetics is an "aid in prosthetic rehabilitation." This indicates a therapeutic or restorative purpose, not a diagnostic one. Diagnostic devices are used to identify or detect medical conditions, diseases, or abnormalities.
No
The device description explicitly states it is made of titanium alloy and lists various physical components (Healing Abutment, Combi Abutment, etc.), indicating it is a hardware device, not software-only.
No, 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, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description: The description clearly states that Implantium Prosthetics is a device made of titanium alloy intended for use as an aid in prosthetic rehabilitation. It lists components like abutments and screws, which are physical implants used in dental procedures.
- Intended Use: The intended use is "as an aid in prosthetic rehabilitation," which involves the physical restoration of missing teeth. This is a clinical procedure performed on the patient, not a laboratory test performed on a sample.
The device is a medical device, but it falls under the category of implantable devices used in dental surgery, not IVDs.
N/A
Intended Use / Indications for Use
Implantium Prosthetics is intended for use as an aid in prosthetic rehabilitation.
Product codes
NHA
Device Description
Implantium Prosthetics is a device made of titanium alloy intended for use as an aid in prosthetic rehabilitation. It consists of Healing Abutment, Combi Abutment, Screw Abutment, Dual Abutment, Angled Abutment, Ball Abutment, Temporary Abutment and Cover screw. Material is of Pure Titanium Grade 4 of ASTM F 67-00 or of Titanium alloy 6A1-4V of ASTM F 136-98. Its surface is partially TiN coated. It is supplied non-sterile.
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
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
§ 872.3630 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
052957
27-5 Leui-Dong, Yeongtong-Gu, Suwon-Si, Gyeonggi-Do, Korea 442-270 | Dentitum
Tel 82 31 207-2200 Fax 82 31 207-3933
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.
Date: ________________________________________________________________________________________________________________________________________________________________________
- Company and Correspondent making the submission:
| Name | Dentium Co., Ltd. |
|---|---|
| Address | 27-5 Leui-Dong, Yeongtong-Gu, |
| Suwon-Si, Gyeonggi-Do, Republic of Korea 442-270 | |
| Phone | +82 31 207-2200 |
| Fax | +82 31 207-3933 |
| Contact | Koo Yeol, Yoon |
2. Device:
Proprietary Name - Implantium Prosthetics Common Name - Abutment Classification Name - Endosseous dental implant abutment
3. Predicate Device:
Implantium, Dentium Co., Ltd. K041368 Astra Tech Implants, Astra Tech Inc., K931767
4. Classifications Names & Citations:
21CFR 872.3630, NHA, Endosseous dental implant abutment, Class II
-
- Description:
Implantium Prosthetics is a device made of titanium alloy intended for use as an aid in prosthetic rehabilitation. It consists of Healing Abutment, Combi Abutment, Screw Abutment, Dual Abutment, Angled Abutment, Ball Abutment, Temporary Abutment and Cover screw. Material is of Pure Titanium Grade 4 of ASTM F 67-00 or of Titanium alloy 6A1-4V of ASTM F 136-98. Its surface is partially TiN coated. It is supplied non-sterile.
- Description:
6. Indication for use:
Implantium Prosthetics is intended for use as an aid in prosthetic rehabilitation.
003919
1
27-5 Leui-Dong, Yeongtong-Gu, Suwon-Si, Gyeonggi-Do, Korea 442-270 | Demtiium
Tel 82 31 207-2200 Fax 82 31 207-3933
Image /page/1/Picture/1 description: The image contains the word "Dentium" in a bold, sans-serif font. The text is black against a white background. The letters are evenly spaced and the word is horizontally oriented.
7. Review:
Implantium Prosthetics has the same device characteristics as the predicate device. Its materials, dimensions, and intended use are similar to devices currently marketed worldwide.
Implantium Prosthetics has been subjected to extensive safety, performance, and product validations prior to release. Safety tests have been performed to ensure the devices comply to applicable industry and US regulations.
8. 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 Prosthetics is safe and effective and substantially equivalent to predicate devices as described herein.
END
000311
2
Image /page/2/Picture/1 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" written around the perimeter of the circle. Inside the circle is a symbol that resembles a stylized eagle or bird with three wing-like shapes. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 27 2006
Dentium Company, Limited C/O Ms. Cathryn N. Cambria Consultant Arkin Consulting Group 5536 Trowbridge Drive Dunwoody, Georgia 30338
Re: K052957
.
Trade/Device Name: Implantium Prosthetics Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: July 12, 2006 Received: July 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 usc 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 mcan 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 fimited 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,
Chris Liu, Ph.D.
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
Indications for Use
510(k) Number (if known): KoSZ957
Device Name: Implantium Prosthetics
Indications for Use: I Implantium Prosthetics is intended for use as an aid in prosthetic rehabilitation.
Prescription Use X (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)
Knut S. Betz DDS for Dr. Susan Renner
Page 1 of 1
cian of Anesthesiology, General Hospital,
cuon Control, Dental Devices
Number: K052957
000009