(140 days)
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.
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 overdenture retention, and six different temporary abutments for placement of temporary restorations.
This 510(k) summary is for Dentium Inc.'s Implantium abutments and focuses on demonstrating substantial equivalence to predicate devices rather than presenting a clinical study with specific acceptance criteria and performance metrics typically found in AI/ML device submissions.
Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and ground truth establishment are not applicable or present in this document.
Here's an analysis based on the provided text, indicating "N/A" where information is not available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices (Implantium, K041368 and Nobel Biocare Brånemark; K042658) | The device is substantially equivalent to the predicate devices, and no additional risks are created. |
| Compliance with intended use for prosthetic rehabilitation including overdenture retention. | The intended use is met by the device for prosthetic rehabilitation including overdenture retention. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: N/A (No specific test set or clinical study described for performance evaluation in this 510(k). Substantial equivalence is primarily based on material, design, and intended use comparison.)
- Data Provenance: N/A (No data provenance mentioned as it's not a clinical study.)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: N/A
- Qualifications of Experts: N/A
4. Adjudication method for the test set
- Adjudication Method: N/A
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No, this is not an AI/ML device, and no MRMC study was performed.
- Effect Size: N/A
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No, this is not an AI/ML device.
7. The type of ground truth used
- Ground Truth Type: N/A (The "ground truth" here is the established safety and effectiveness of the predicate devices based on their prior clearance.)
8. The sample size for the training set
- Sample Size for Training Set: N/A (Not an AI/ML device; no training set.)
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: N/A (Not an AI/ML device; no training set.)
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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 AvenueCypress, 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, K041368Nobel Biocare Brånemark; K042658 |
| Device description: | The Implantium abutments are devices made of pure titanium, titaniumalloys, and plastic. The abutments in this 510(k) submission are sup-plemental to the previously cleared Implantium devices (K041368) andare designed to be used with the Implantium fixtures. These abutmentsare placed in the fixtures as a support for fitting prosthetic teeth. Thissubmission includes four differently sized ball abutment kits for over-denture retention, and six different temporary abutments for placementof temporary restorations. |
| Intended use: | The Implantium abutments are intended to be used with the Implantiumroot-form endosseous dental implant to aid in prosthetic rehabilitationincluding overdenture retention. After the root-form endosseous dentalimplant is surgically placed, the endosseous dental implant abutmentdevice 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.
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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
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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.
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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
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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
§ 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.)