(140 days)
No
The 510(k) summary describes a purely mechanical dental abutment and makes no mention of AI or ML technology.
No
The device aids in prosthetic rehabilitation and supports fitting prosthetic teeth, but it does not treat or cure a disease or condition.
No
The provided text describes the Implantium abutments as devices used for prosthetic rehabilitation and supporting prosthetic teeth, primarily for overdenture retention. There is no mention of the device being used to diagnose a medical condition or disease.
No
The device description explicitly states the abutments are made of pure titanium, titanium alloys, and plastic, indicating they are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "prosthetic rehabilitation including overdenture retention" and the device is "attached to it [the implant] to aid in prosthetic rehabilitation". This describes a device used in vivo (within the body) for structural support and prosthetic attachment.
- Device Description: The description details the materials (titanium, plastic) and function ("placed in the fixtures as a support for fitting prosthetic teeth"). This aligns with a medical device used for physical support and attachment, not for testing biological samples in vitro.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
Therefore, the Implantium abutments described are a medical device used for dental prosthetic rehabilitation, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Implantium abutments are intended to be used with the Implantium root-form endosseous dental implant to aid in prosthetic rehabilitation including overdenture retention. After the root-form endosseous dental implant is surgically placed, the endosseous dental implant abutment device is attached to it.
Product codes
NHA
Device Description
The Implantium abutments are devices made of pure titanium, titanium alloys, and plastic. The abutments in this 510(k) submission are supplemental to the previously cleared Implantium devices (K041368) and are designed to be used with the Implantium fixtures. These abutments are placed in the fixtures as a support for fitting prosthetic teeth. This submission includes four differently sized ball abutment kits for over-denture retention, and six different temporary abutments for placement of temporary restorations.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Implantium, K041368, Nobel Biocare Brånemark; K042658
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
FEB 2 1 2006
Image /page/0/Picture/1 description: The image shows the word "Dentium" in a bold, sans-serif font. The word is partially enclosed within a square root symbol, with the vertical line of the root extending upwards to the left of the "D". The word is in black, and the background is white.
6761 Katella Avenue Cypress, CA 90630 (714) 890-6666 • (714) 890-6360 fax
2. 510(k) Summary
| Date: | 29 September 2005 |
|---|---|
| Applicant: | Dentium Inc. |
| 6761 Katella Avenue | |
| Cypress, CA 90630 | |
| Owner/Operator #: | 9072183 |
| Contact person: | Klaas Besseling |
| Phone numbers: | |
| (Contact person) | (949) 466-7472 mobile |
| (949) 448-0312 fax | |
| Email address: | kbesseling@spherelink.com |
| Device name: | Implantium abutments |
| Common name: | Endosseous dental implant abutments |
| Classification: | Class II |
| Product Code: | NHA |
| Regulation number: | 21CFR872.3630 |
| Predicate devices: | Implantium, K041368 |
| Nobel Biocare Brånemark; K042658 | |
| Device description: | The Implantium abutments are devices made of pure titanium, titanium |
| alloys, and plastic. The abutments in this 510(k) submission are sup- | |
| plemental to the previously cleared Implantium devices (K041368) and | |
| are designed to be used with the Implantium fixtures. These abutments | |
| are placed in the fixtures as a support for fitting prosthetic teeth. This | |
| submission includes four differently sized ball abutment kits for over- | |
| denture retention, and six different temporary abutments for placement | |
| of temporary restorations. | |
| Intended use: | The Implantium abutments are intended to be used with the Implantium |
| root-form endosseous dental implant to aid in prosthetic rehabilitation | |
| including overdenture retention. After the root-form endosseous dental | |
| implant is surgically placed, the endosseous dental implant abutment | |
| device is attached to it. |
Conclusion
To the best of our knowledge, the devices are substantially equivalent to the predicate devices, and no additional risks are created.
1
4. Indications for use
510(k) number:
Device name: Implantium abutments
Intended use: The Implantium abutments are intended to be used with the Implantium root-form endosseous dental implant to aid in prosthetic rehabilitation including overdenture retention. After the root-form endosseous dental implant is surgically placed, the endosseous dental implant abutment device is attached to it.
Concurrence of CDRH, Office of Device Evaluation
Prescription use (Per 21CFR801.109)
X
or
Over-The-Counter use
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three heads, representing the department's focus on health, human services, and science. The eagle is surrounded by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement. The logo is simple and recognizable, conveying the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 1 2006
Mr. Klaas Besseling Director Dentium, Incorporated 28711 Jaeger Drive Laguna Niguel, California 92677
Re: K052823
Trade/Device Name: Implantium Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous dental implant abutment Regulatory Class: Class II Product Code: NHA Dated: February 13, 2006 Received: February 16, 2006
Dear Mr. Besseling:
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 - Mr. Klaas Besseling
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,
Ove
Shi-Jian, 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
4. Indications for use
510(k) number:
Implantium abutments Device name:
The Implantium abutments are intended to be used with the Im-Intended use: plantium root-form endosseous dental implant to aid in prosthetic rehabilitation including overdenture retention. After the root-form endosseous dental implant is surgically placed, the endosseous dental implant abutment device is attached to it.
Concurrence of CDRH, Office of Device Evaluation
Super Quano
eather
U.S
Prescription use (Per 21CFR801.109)
X
or
Over-The-Counter use