(23 days)
No
The description focuses on the physical characteristics, materials, and intended use of a dental implant system, with no mention of AI or ML capabilities.
No
The device is a dental implant system used to anchor a fixed dental prosthesis, which is typically considered a restorative or prosthetic device, not a therapeutic device meant to treat or cure a disease or condition.
No
The device is a dental implant system designed to replace missing teeth, not to diagnose medical conditions or diseases. Its purpose is structural and restorative.
No
The device description clearly states it is a machined commercially pure titanium screw form implant, which is a physical hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The provided text describes a dental implant system. This system is a physical device implanted into the jawbone to support dental prostheses. It is used in vivo (within the living body), not in vitro (in a test tube or laboratory setting).
- Intended Use: The intended use clearly states it's for use in the mouth to support dental restorations. This is a surgical and prosthetic application, not a diagnostic test performed on a sample.
The device is a surgical implant used for reconstructive purposes in dentistry.
N/A
Intended Use / Indications for Use
The ACE Surgical Internal Connection 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. The indication/intended use of the modified device, the ACE Surgical Internal Connection Screw Dental Implant System, as described in its labeling has not changed from that of the predicates.
Product codes
DZE
Device Description
The ACE Surgical Internal Connection Screw Dental Implant System is a machined commercially pure titanium screw form implant intended to be implanted into the upper or lower jaw to serve as an anchor for a fixed dental prosthesis or single tooth restorations, constructed with an internal hexagon feature for inserting the implant into its surgical site, and to stabilize the prosthesis for rotational load, used to reconstruct the dentition of a patient who is wholly edentulous, supplied in diameters of 3.75. 4.0. 4.75, and 5.75 mm, and in lengths of 8, 10, 11.5, 13, and 15 mm. The implant raw materially pure titanium CP-4 as specified in ASTM F67-95 - Standard Specification for Unalloyed Titanium for Surgical Implant Applications. The implant surface is roughened by means of a blast media process to aid in implant adhesion. The candidate devices are identical in materials and characteristics to that cleared under K954513. The ACE Surgical Internal Connection Screw Dental Implant System is a comprehensive system retaining prosthetic components, auxiliary components, and surgical tools as does the predicate ACE Surgical Screw Dental implant to assist with the implant's insertion and final prosthetic fabrication.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
bench test results, bench testing demonstrated there was no difference in the performance, safety, or effectiveness between the ACE Surgical Internal Connection Screw Dental Implant System and the specified predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ACE Screw Dental implant System, K954513
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Ace Surgical Supply Co., Inc.
Special 510(k) Notification: Internal Connection Screw Dental Implant System
JUL 22 2004
Attachment 1 - 510(k) Summary
| Submitter Name: | ACE Surgical Supply Co., Inc. |
|---|---|
| Submitter Address : | 1034 Pearl St., Brockton, MA 02301 |
| Contact Person: | J. Edward Carchidi, DDS |
| Phone Number: | (508) 588-3100 |
| Fax Number: | (508) 523-3140 |
| Date Prepared: | June 2004 |
| Device Trade Name: | ACE CONNECT™ Internal Connection Screw Dental Implant System |
| Device Common Name: | Screw Dental Implant |
| Classification Name: | Endosseous Dental Implant, product code DZE |
| Predicate device: | ACE Screw Dental implant System, K954513 |
| Reason for submission: | Not previously marketed in the USA |
Device Description and Materials:
The ACE Surgical Internal Connection Screw Dental Implant System is a machined commercially pure titanium screw form implant intended to be implanted into the upper or lower jaw to serve as an anchor for a fixed dental prosthesis or single tooth restorations, constructed with an internal hexagon feature for inserting the implant into its surgical site, and to stabilize the prosthesis for rotational load, used to reconstruct the dentition of a patient who is wholly edentulous, supplied in diameters of 3.75. 4.0. 4.75, and 5.75 mm, and in lengths of 8, 10, 11.5, 13, and 15 mm. The implant raw materially pure titanium CP-4 as specified in ASTM F67-95 - Standard Specification for Unalloyed Titanium for Surgical Implant Applications. The implant surface is roughened by means of a blast media process to aid in implant adhesion. The candidate devices are identical in materials and characteristics to that cleared under K954513.
The ACE Surgical Internal Connection Screw Dental Implant System is a comprehensive system retaining prosthetic components, auxiliary components, and surgical tools as does the predicate ACE Surgical Screw Dental implant to assist with the implant's insertion and final prosthetic fabrication.
Intended Use:
The ACE Surgical Internal Connection 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. The indication/intended use of the modified device, the ACE Surgical Internal Connection Screw Dental Implant System, as described in its labeling has not changed from that of the predicates.
Substantial Equivalence/ Device Technological Characteristics
and Comparison to Predicate Device(s):
The ACE Surgical Internal Connection Screw Dental Implant System is substantially equivalent to the ACE Surgical Screw Dental Implant System, K954513.
Among the information and data presented in the 510(k) submission to support the substantial equivalency of the ACE Surgical Internal Connection Screw Dental Implant System to the specified predicate devices are: 1) device description, 2) indications for use, 3) bench test results, 4) materials, and 5) labeling. In particular, the bench testing demonstrated there was no difference in the performance, safety, or effectiveness between the ACE Surgical Internal Connection Screw Dental Implant System and the specified predicate devices.
A1-1
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human figures or birds in flight, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 2 2004
Dr. J. Edward Carchidi President Ace Surgical Supply Company Limited 1034 Pearl Street Brockton, Massachusetts 02301
Re: K041759
Trade/Device Name: ACE CONNECT™ Internal Connection Screw Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: June 28, 2004 Received: June 29, 2004
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.
2
Page 2 - Dr. Carchidi
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 (301) 594-4613. 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/dsma/dsmamain.html
Sincerely yours,
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
3
ACE Surgical Supply Co., Inc. Additional Requested Information, K041759 Special 510(k) Notification, Amended Submission Special 510(K) Notineation, Connection Screw Dental Implant System
1034 Pearl Street 02301 ATTACH 4A
Indications for Use
510(k) Number (if known): _K041759 _________________________________________________________________________________________________________________________________________
ACE CONNECT™ Internal Connection Screw Dental Device Name: Implant System
Indications for Use:
The ACE CONNECT™ Internal Connection Screw Dental Implant System is The ACE CONNEOT - - Internal Schinestion of maxillae or as a terminal intention to be used in totally ouch and our removable bridgework. The system can also be used for single tooth restorations.
AND/OR Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Quaser
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Division Sign-Off) Division of Anesthesiology General Hospital, Infection Control. Dental Devices
510(k) Number ..