(14 days)
The Ace HA Screw Dental Implant System is intended to be used in totally edentulous mandibles or maxillae or as a terminal or intermediary abutment for fixed or removable bridgework. The system can also be used for single tooth restorations.
Not Found
I am sorry, but based on the provided text, I cannot answer your request. The document is a 510(k) premarket notification acceptance letter for a dental implant system. It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain the following information that would allow me to answer your questions:
- Acceptance criteria and reported device performance: There are no specific performance metrics, benchmarks, or test results mentioned for the Ace HA Screw Dental Implant System.
- Details of any studies: There is no description of any clinical or non-clinical studies conducted for this device, including information on sample sizes, data provenance, ground truth establishment, expert involvement, or adjudication methods.
- Information regarding AI or algorithm performance: The device described is a physical dental implant system, not a software device or an AI-powered system. Therefore, questions related to standalone algorithm performance, AI assistance, or MRMC studies are not applicable.
The document is purely an administrative confirmation of market clearance based on substantial equivalence, not a detailed report of device testing or performance.
{0}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. J. Edward Carchidi ACE Surgical Supply Company Limited 1034 Pearl Street Brockton, Massachusetts 02301
Re: K021244
Trade/Device Name: Ace HA Screw Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: April 15, 2002 Received: April 19, 2002
Dear Dr. Carchidi:
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.
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.
Image /page/0/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle are three stylized human profiles facing to the right, with flowing lines representing hair or movement. The logo is black and white and appears to be a scanned image.
{1}------------------------------------------------
Page 2 - Dr. Carchidi
You must comply with all the Act's requirements, including, but not limited to: registration r ou must config17 with and 807); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 OF RT Far 807), Modity systems (QS) regulation (21 CFR Part 820); and if requirence as betwents 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 1110 letter vill and in your of your of substantial equivalence of your device to 310(t) promiser nounce 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the and additionally 21 Cl (301) 594-4613. Additionally, for questions on the promotion and Office of Comphance wice, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Ace Surgical Supply Co., Inc ..
Special 510(k) Notification: HA Screw Dental Implant System
Attachment 4 - Indications for Use Enclosure
510(k) Number: _ KO21244
Device Name: Ace HA Screw Dental Implant System
Intended Use / Indications for Use:
The Ace HA Screw Dental Implant System is intended to be used in totally edentulous mandibles or maxillae or as a terminal or intermediary abutment for fixed or removable bridgework. The system can also be used for single tooth restorations.
(PLEASE DO NOT WRITE BELOW THIS LINE/CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Punr
(Division Sign-Off) (Division of Dental, Infection Control, and General Hospital C 510(k) Number -
Prescription Use (per 21 CFR 801.109)
OR
Over the Counter Use _ Optional Format 1-2-96
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.