(83 days)
Not Found
Not Found
No
The summary describes a dental implant system and does not mention any AI or ML capabilities.
No
Explanation: The device is an implant system providing support for dental prosthetics, which is a structural and supportive function, not directly therapeutic (i.e., treating or curing a disease or condition). It aids in rehabilitation but doesn't have a direct therapeutic effect on a medical condition.
No
Explanation: The device is an implant system used to provide support for crowns, bridges, or overdentures. Its intended use is to provide physical support, not to diagnose a condition or disease.
No
The intended use describes a physical dental implant system, which is a hardware device. There is no mention of software in the provided text.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an implant system used in the body (maxillary and/or mandibular arches) to support dental prosthetics. IVDs are used outside the body to examine specimens (like blood, urine, or tissue) to provide information about a person's health.
- Device Description (though not found): While the description is missing, the intended use strongly suggests a physical implant, not a reagent, instrument, or software used for testing biological samples.
- Anatomical Site: The device is used in the maxillary and/or mandibular arches, which are parts of the human body. IVDs analyze samples from the body.
Therefore, the American Dental Implant System, as described, is a medical device intended for surgical implantation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The American Dental Implant System is intended to be used in the maxillary and/or mandibular arches to provide support for crowns, bridges, or overdentures for edentulous or partially edentulous patients. As per Part 21, CFR 801 Subpart D, this item is for Prescription Use and as such is only sold on or by the order of a licensed dentist.
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
maxillary and/or mandibular arches
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed dentist / Not Found
Description of the training set, sample size, data source, and annotation protocol
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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/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular pattern around the eagle. The eagle is depicted in a simple, black and white design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 6 2008
Ms. Gina Hennon Chief Executive Officer American Dental Implant Corporation 2415 Wilmington Road New Castle, Pennsylvania 16105
Re: K080397
Trade/Device Name: American Dental Implant Abutment System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: April 21, 2008 Received: April 28, 2008
Dear Ms. Hennon:
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 - Ms. Hennon
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,
Sayite H. Micheal m.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
2
Indications for Use
510(k) Number (if known): K080397
Device Name: American Dental Implant Abutment System
Indications For Use:
The American Dental Implant System is intended to be used in the maxillary and/or mandibular arches to provide support for crowns, bridges, or overdentures for edentulous or partially edentulous patients. As per Part 21, CFR 801 Subpart D, this item is for Prescription Use and as such is only sold on or by the order of a licensed dentist.
Prescription Use J (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kira Mulvey for MSR
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
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510(k) Number: K080397