(154 days)
NHA
Not Found
No
The summary describes a dental implant system and CAD/CAM abutments, focusing on mechanical components and manufacturing processes. There is no mention of AI, ML, image processing for analysis, or any data-driven decision-making components. The use of "CAD/CAM techniques" refers to computer-aided design and manufacturing, which is a standard digital workflow but does not inherently involve AI/ML for analysis or prediction.
No
The device, a dental implant system, is used to support prosthetic devices and restore chewing function, not for treating or diagnosing diseases or conditions.
No
The provided text describes the Faico Dental Implant System, CAD/CAM Abutments, and their intended use in restorative dentistry, specifically for supporting prosthetic devices and restoring chewing function. It does not mention any diagnostic capabilities or functions.
No
The device description and intended use clearly describe physical dental implants and abutments, which are hardware components. While CAD/CAM techniques are mentioned for designing abutments, the core device is a physical implant system.
Based on the provided information, the Faico Dental Implant System and FAICO CAD/CAM Abutments are not In Vitro Diagnostic (IVD) devices.
Here's why:
- Intended Use: The intended use clearly describes devices used for surgical placement in the bone and providing support for prosthetic devices to restore chewing function. This is a direct interaction with the patient's body for a therapeutic purpose.
- Anatomical Site: The devices are placed in the bone of the upper or lower jaw, which is an in-vivo application.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a physiological or pathological state.
- Being used for diagnosis, monitoring, or screening.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. The Faico Dental Implant System and Abutments are medical devices used for surgical and restorative procedures directly on the patient.
N/A
Intended Use / Indications for Use
Faico Dental Implant System is indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading for use in surgical (single-stage or two-stage procedures) and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic device such as artificial teeth and to restore the patient's chewing function. The System is intended to be used in either single tooth or multiple teeth applications.
FAICO CAD/CAM Abutments are dental abutments placed onto a dental implant to provide support for dental prosthetic restorations. The abutments include: 1) Titanium abutment blanks with a pre-machined implant connection where the upper portion may be custom- milled in accordance with a patient- specific design using CAD/CAM techniques; and 2) Titanium bases with a pre-machined implant connection upon which a CAD/ CAM designed superstructure may be fitted to complete a two-piece dental abutments include an abutment screw for fixation to the underlying implant. The abutments may be used for single-unit (singletooth) or multiple-unit (bridges and bars) restorations and are compatible for use with FAICO Dental Implants with internal hex- connection mating platform and conical connection platform diameters.
All digitally designed abutments and/or copings for use with FAICO CAD/CAM Abutments are intended to be sent to a FAICO-validated milling center for manufacture. FAICO abutments designed using CAD/CAM techniques must fulfill the FAICO allowable range of design parameters."
Product codes
NHA
Device Description
Not Found
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
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)
Not Found
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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "U.S. Food & Drug Administration" in blue.
FAICO Medical LLC % Raymond Kelly Consultant Arazy Group 3422 Leonardo Lane New Smyrna Beach, Florida 32168
Re: K211871
Trade/Device Name: Faico Dental Implant System and CAD/CAM Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: October 27, 2021 Received: October 29, 2021
Dear Raymond Kelly:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211871
Device Name
Faico Dental Implant System and CAD/CAM Abutments
Indications for Use (Describe)
Faico Dental Implant System is indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading for use in surgical (single-stage or two-stage procedures) and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic device such as artificial teeth and to restore the patient's chewing function. The System is intended to be used in either single tooth or multiple teeth applications.
FAICO CAD/CAM Abutments are dental abutments placed onto a dental implant to provide support for dental prosthetic restorations. The abutments include: 1) Titanium abutment blanks with a pre-machined implant connection where the upper portion may be custom- milled in accordance with a patient- specific design using CAD/CAM techniques; and 2) Titanium bases with a pre-machined implant connection upon which a CAD/ CAM designed superstructure may be fitted to complete a two-piece dental abutments include an abutment screw for fixation to the underlying implant. The abutments may be used for single-unit (singletooth) or multiple-unit (bridges and bars) restorations and are compatible for use with FAICO Dental Implants with internal hex- connection mating platform and conical connection platform diameters.
All digitally designed abutments and/or copings for use with FAICO CAD/CAM Abutments are intended to be sent to a FAICO-validated milling center for manufacture. FAICO abutments designed using CAD/CAM techniques must fulfill the FAICO allowable range of design parameters."
| Type of Use ( Select one or both, as applicable ) | ||
|---|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) □ Over-The-Counter Use (21 CFR 801 Subpart C) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
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