(27 days)
No
The summary describes a dental implant with a modified connection, not a software or imaging device that would typically incorporate AI/ML. There are no mentions of AI, ML, image processing, or performance studies related to algorithmic analysis.
Yes
This device is a dental implant used to support prosthetic devices, which is a therapeutic function.
No
The device is described as an "endosseous dental implant" used to provide support for prosthetic devices, which is a therapeutic rather than diagnostic function.
No
The device description clearly states it is an "endosseous dental implant," which is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For use as an endosseous dental implant in the upper or lower jaw arches to provide support for prosthetic devices." This describes a device that is surgically implanted into the body to provide structural support.
- Device Description: The description confirms it's a dental implant system.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze biological samples. This device is used inside the body as a structural component.
N/A
Intended Use / Indications for Use
The Endopore Implant is indicated for use in the upper or lower jaw arches to provide support for a dental prosthesis.
For use as an endosseous dental implant in the upper or lower jaw arches to provide support for prosthetic devices.
Product codes
DZE, NHA
Device Description
The principles of operation of the modified device are identical to the previously cleared Endopore Implant System except for the attachment of abutments via an internal connection.
The technological characteristics of the modified Scalloped Endopore Implant also are identical to the predicates, except for the addition of a 1.5 mm lightly-acid etched region immediately apical to the smooth coronal region, and a scalloped coronal margin. The dimensions of the modified Scalloped Endopore Implant, 10.5 mm in length x 4.8 mm diameter, are within the range of the dimensions of previously cleared Endopore implants.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper or lower jaw arches
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)
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.)
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510(K) SUMMARY FOR THE INNOVA CORPORATION SCALLOPED ENDOPORE IMPLANT
DEC 1 4 2004
Submitter's Name, Address, Telephone Number, And Contact Person
Innova LifeSciences Corporation 525 University Avenue, Suite 777 Toronto, Ontario M5G 2L3 Canada
Contact: Michael A. Kehoe, President Telephone: (416) 340-8818 Facsimile: (416) 340-0415
Date Prepared
November 12, 2004
Name of the Device
Scalloped Endopore® Endosseous Dental Implant System
Common or Usual Name
Endosseous Implant and Abutment
Classification Name
Endosseous Implant (DZE) ; Endosseous Dental Implant Abutment (NHA)
Predicate Devices
Endopore® Endosseous Dental Implant System in 4.1 mm diameter
(K926354) and 5.0 mm diameter (K971196); 5 mm long x 5.0 mm diameter
Endopore Endosseous Dental Implant System (K032140).
Intended Use
The Endopore Implant is indicated for use in the upper or lower jaw arches to provide support for a dental prosthesis.
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The principles of operation of the modified device are identical to the previously cleared Endopore Implant System except for the attachment of abutments via an internal connection.
Technological Characteristics
The technological characteristics of the modified Scalloped Endopore Implant also are identical to the predicates, except for the addition of a 1.5 mm lightly-acid etched region immediately apical to the smooth coronal region, and a scalloped coronal margin. The dimensions of the modified Scalloped Endopore Implant, 10.5 mm in length x 4.8 mm diameter, are within the range of the dimensions of previously cleared Endopore implants.
Summary Basis for the Finding of Substantial Equivalence
The minor modification to the surface of the Endopore Implant does not alter its indications for use or its fundamental scientific technology. Therefore, the modified device is substantially equivalent to the predicates.
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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized symbol that resembles three abstract shapes stacked on top of each other, possibly representing human figures or abstract forms.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 4 2004
Mr. Howard M. Holstein Innova LifeSciences Corporation 555 Thirteenth Street, NW Washington, DC 20004-1109
Re: K043190
Trade/Device Name: Scalloped Endopore Endosseous Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: NHA Dated: December 10, 2004 Received: December 10, 2004
Dear Mr. Holstein:
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.
3
Page 2 - Mr. Holstein
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 (OS) 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/dsma/dsmamain.html
Sincerely yours,
Chiu Lin, Ph.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
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Indications for Use
510(k) Number (if known): K (H3190
Device Name: Scalloped Endopore® Endosseous Dental Implant System
Indications For Use:
For use as an endosseous dental implant in the upper or lower jaw arches to provide support for prosthetic devices.
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
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)
Suoer Rumm
(Division Sign-Off)
Division of Anesthesiology, General Hospital.
Division of Anesthesiology, Gental Devices Division of Anesthesion of Anesther Devices
510(k) Number:__
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