(438 days)
Not Found
No
The summary describes a standard dental implant system made of titanium with various sizes and surface finishes. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities.
Yes.
The device is intended for surgical implantation to provide prosthetic support for dental restorations, which is a therapeutic purpose.
No
The device is a dental implant system used for prosthetic support, not for diagnosing medical conditions.
No
The device description explicitly states it is a "CP titanium implant" and describes its physical characteristics (self-tapping or standard screw-type design, surface finish, lengths, and diameters), indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The description clearly states that the 3A Dental Implant System is a surgical implant intended for placement within the body (in the maxillary and/or mandibular arches) to support dental restorations. It is a physical device implanted into the patient.
The information provided describes a surgical implant, not a device used for testing biological samples.
N/A
Intended Use / Indications for Use
The 3A Dental Implant System is intended for single or multiple surgical implantation (with or without tissue integration) in the maxillary and or mandibular arches for the purpose of providing prosthetic support for dental restorations in partially or totally edentulous individuals. May be used for single tooth restoration.
Product codes
DZE
Device Description
The 3A Dental Implant System is a CP titanium implant that are self-tapping or standard screw-type design. The implant body has a surface finish for either smooth (bright) or The implants are available in various insertion lengths and textured (abrasive blasted). diameters
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Mandible and Maxilla
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)
Testing of a "typical" or representative, standard system configuration utilizing an "angled abutment" was conducted on samples of titanium. The testing demonstrated performance sufficient to assure both safe and efficacious use of the implant system.
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
§ 872.3640 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
12.0 SUMMARY OF SAFETY AND EFFECTIVENESS
| Distributor: | Osseco Biosource, Ltd.
64 Old Orchard, Suite 320
Skokie, Illinois 60077 |
|------------------------|-------------------------------------------------------------------------------|
| Regulatory Contact: | Michele H. Vovolka
Vantage Consulting International, Ltd |
| Telephone Number: | 847-856-0355 |
| Fax Number: | 847-856-0357 |
| Date Summary Prepared: | May 29, 2001 |
| Product Trade Name: | 3A Dental Implant System |
| Common Name: | Endosseous Implant |
| Classification: | Endosseous Implant
Class III per 21 CFR 872.3640 |
| Predicate Devices: | Brånemark Nobel Biocare
ITI Dental Implant System |
Description:
The 3A Dental Implant System is a CP titanium implant that are self-tapping or standard screw-type design. The implant body has a surface finish for either smooth (bright) or The implants are available in various insertion lengths and textured (abrasive blasted). diameters
Intended Uses/Indications:
The 3A Dental Implant System is intended for single or multiple surgical implantation (with or without tissue integration) in the maxillary and or mandibular arches for the purpose of providing prosthetic support for dental restorations in partially or totally edentulous individuals. May be used for single tooth restoration.
1
Substantial Equivalence:
| Characteristic | 3A Dental
Implant Systems | Brånemark
Nobel Biocare
K993595 | ITI Dental
Implant System
K002374 |
|---------------------|-------------------------------------|---------------------------------------|-----------------------------------------|
| Indications for Use | Mandible and
Maxilla | Same | Same |
| Design: | External Hex and
Morse Taper | Same | Same |
| Material | Titanium and
Titanium Alloy | Same | Same |
| Implant Sterile | Yes | Same | Same |
| Implant Diameters | 3.75 – 5.5 mm | Equivalent | Equivalent |
| Implant Lengths | 7 – 18 mm | Equivalent | Equivalent |
| Attachments | Various abutments
and components | Equivalent | Equivalent |
| Product Code | DZE | Same | Same |
COMPARISON TABLE
Summary of Testing:
Testing of a "typical" or representative, standard system configuration utilizing an "angled abutment" was conducted on samples of titanium. The testing demonstrated performance sufficient to assure both safe and efficacious use of the implant system.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines above them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 7 2002
Osseco Biosource, Limited C/O Ms. Michele H. Vovolka Vantage Consulting International, Litimed P.O. Box 848 Grayslake, Illinois 60030
Re: K011879
Trade/Device Name: 3A Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: May 27, 2002 Received: May 29, 2002
Dear Ms. Vovolka:
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.
3
Page 2 - Ms. Vovolka
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 Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
KO11879 510(k) Number (if known):
3A Dental Implant System Device Name:
Indications For Use:
The 3A Dental Implant System is intended for single or multiple surgical implantation (with or without tissue integration) in the maxillary and or mandibular arches for the purpose of providing prosthetic support for dental restorations in partially or totally edentulous individuals. May be used for single tooth restoration.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR (Per 21 CFR 801.109)
Over -The-Counter Use
Susan Runner
Division Sign Off
(Division Sign-Off) Division of Dental, Infection Control, And General Hospital Devices
510(k) Number K011879
Osseco Biosource, Ltd. 510(k) Notification