(15 days)
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Not Found
No
The summary describes a dental implant, a purely mechanical device, and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
Yes
The device is an endosseous implant intended to restore the patient's chewing function, which addresses a medical condition or ailment.
No
The device description states it is an "Endosseous Implant" that is "surgically placed in the bone of the upper or lower jaw" to restore chewing function, indicating it is a prosthetic device, not one used for diagnosis.
No
The device description clearly states it is a "Dental Implant," which is a physical hardware device intended for surgical placement. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is "surgically placed in the bone of the upper or lower jaw" to restore chewing function. This describes a surgical implant, which is a medical device used in vivo (within the body).
- Device Description: The description "OCO Dental Implant" further confirms it's a physical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health.
IVD devices are used to diagnose, monitor, or screen for diseases or conditions by analyzing samples taken from the body. This device is a therapeutic device used to replace missing teeth.
N/A
Intended Use / Indications for Use
"0" Company's OCO Endosseous Implant is intended to be surgically placed in the bone of the upper or lower jaw surgically praced in the bone of the or still devices resulting arches providing bart the patient's chewing function.
Product codes
NHA
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, bold font. The background is plain and white.
Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850
Mr. David D. Dalise President "O" Company Incorporated 600 Paisano, N.E., Suite A Albuquerque. New Mexico 87123
Re: K021460
Trade/Device Name: OCO Dental Implant Regulation Number: 872.3640 Regulation Name: Dental Implant Regulatory Class: III Product Code: NHA Dated: May 2, 2002 Received: Mav 7, 2002
Dear Mr. Dalise:
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.
1
Page 2 – Mr. Dalise
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, 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
510(k) Number (if known):
Device Name: OCO Dental Implant (3.25mm diameter)
Indications For Use:
"0" Company's OCO Endosseous Implant is intended to be surgically placed in the bone of the upper or lower jaw surgically praced in the bone of the or still devices resulting arches providing bart the patient's chewing function.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
Shoser Runner
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number . CON 141