(105 days)
Not Found
Not Found
No
The summary describes a mechanical dental implant attachment system and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No.
The device is described as an "Implant Anchor Abutment" and an "Implant Bar Attachment System" for dental implants, which are components for retaining dentures, not for treating a disease or condition.
No
The text describes the device as an "Implant Anchor Abutment" and an "Implant Bar Attachment System" for dental implants, used to retain overdentures or partial dentures. This indicates a role in treatment or prosthetic support, not diagnosis. The "Intended Use" section clearly outlines its function in retaining dentures with implants, which is a therapeutic or prosthetic purpose rather than identifying a disease or condition.
No
The device is described as an "Implant Anchor Abutment" and "Implant Bar Attachment System," which are physical components used with dental implants. The description does not mention any software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used in vivo (within the body) for retaining dentures on dental implants. IVDs are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: While the description is "Not Found," the intended use clearly places the device in a surgical/dental context, not a laboratory testing context.
- Other Sections: The absence of information related to image processing, AI/ML, imaging modalities, training/test sets, performance studies, and key metrics further supports that this is not an IVD. These elements are often associated with IVDs, especially those involving digital analysis of biological samples.
In summary, the function of this device is to physically connect dentures to dental implants within a patient's mouth, which is a clinical procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Locator Implant Anchor Abutment for Endosseous Dental Implants is appropriate for use with overdentures or partial dentures retained in whole or in part by endosseous implants in the mandible or maxilla.
The Locator Implant Bar Attachment System for Endosseous Dental Implants is appropriate for use with overdentures or partial dentures retained in whole or in part by bar splinted endosseous implants in the mandible or maxilla.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandible or maxilla
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. The text is arranged to follow the curve of the circle, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the left side and "USA" on the right.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 5 2009
Mr. Richard A. Overton, P.E. Zest Anchors, Incorporated 2061 Wineridge Place Escondido, California 92029
Re: K083324
Trade/Device Name: Locator Implant Anchor Attachment System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: January 23, 2009 Received: January 26, 2009
Dear Mr. Overton:
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.
1
Page 2 - Mr. Overton
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Siser Kumer
Cista V. Michael, MD
Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE
510(k) Number:
Device Name:
Locator Implant Anchor Abutment for Endosseous Dental Implant Locator Implant Bar Attachment System for Endosseous Dental Implant
Indications for Use:
The Locator Implant Anchor Abutment for Endosseous Dental Implants is appropriate for use with overdentures or partial dentures retained in whole or in part by endosseous implants in the mandible or maxilla.
The Locator Implant Bar Attachment System for Endosseous Dental Implants is appropriate for use with overdentures or partial dentures retained in whole or in part by bar splinted endosseous implants in the mandible or maxilla.
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Turner
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K083304