(152 days)
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No
The document describes a dental implant system and its physical characteristics, materials, and intended use. There is no mention of AI, ML, image processing, or any data-driven algorithms.
Yes
The device, AIDI Dental Implant Systems®, is intended to restore patient esthetics and chewing function, indicating a therapeutic purpose to improve a patient's health-related quality of life.
No
The device is a dental implant system designed to support prosthetic teeth, restoring esthetics and chewing function. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is a "threaded root-form dental implant" and includes details about its physical characteristics, material composition (Titanium), and surgical placement. This indicates it is a physical hardware device, not software only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a dental implant system surgically placed in the bone to support prosthetic devices. This is a surgical implant, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details the physical characteristics, materials, and design of a dental implant and abutments. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. The device's function is purely mechanical and structural within the body.
Therefore, the AIDI Dental Implant System is a medical device, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
AIDI Dental Implant Systems® (AIDI Fixtures and AIDI Abutments with Screws) are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Straight abutments indicated for both screw and cemented retention options are included. The implants are indicated for single or multiple unit restorations and can be used in splinted and non splinted applications. The device is intended for immediate placement and immediate loading when good primary stability has been achieved and with appropriate occlusal loading.
Product codes
DZE
Device Description
AID! Dental Implant System (AIDI) is a threaded root-form dental implant intended for use (function) in the upper and lower jaw arches to support prosthetic devices, such as an artificial tooth, in order to restore esthetics and chewing function to partially or fully edentulous patients. Also included are straight abutments which provide cemented and screw retained restorative options.
AIDI is an improved version of the predicated IDI Implant System (IDI). AIDI has the same scientific concepts as predicated IDI which include same internal connection design, same internal thread at apical end, same thread design at external surfaces and same surface treatment which is Soluable Blast Media (SBM).
The physical and performance characteristic of AIDI, predicated IDI and predicated NobelActive Dental Implant (NA) includes gradually expanding tapered implant body allowing for alveolar bone expanding and condensing capabilities. The material composition of AIDI and predicated IDI are Titanium ASTM F67 Grade 4 or ASTM F-136 6AL4V ELI. AIDI is also similar to predicated NA Implants in tapered coronal design and hex-cavity internal connection design.
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
upper or lower jaw arches
Indicated Patient Age Range
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Intended User / Care Setting
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Test Summary: The nonclinical test data of AIDI Dental Implant System Torque Test Report revealed a high torque strength for AIDI Dental Implants. The predicated IDI™ implant and predicated NobelActive™ dental implant resembled the same torque strength.
Clinical Test Summary: No clinical studies are submitted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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510 (K) Summary of Safety and Effectiveness (Revised on 10/7/2010)
NOV 2 2 2 2010
| Submitted by: | William Yuen-Siang hung, D.D.S., J.D. |
|---|---|
| Address: | AIDI Biomedical, LLC |
| 34859 Frederick St #105 | |
| Wildomar CA 92595 | |
| Telephone: | (951)678-9626 |
| Direct: | (951)288-8819 |
| Fax: | (951)678-6786 |
| Date of Submission: | May 18th, 2010 |
| Classification Name | Endosseous dental implant 21 CFR 872.3640 and endosseous dental |
| implant abutment 21 CFR 872.3630 | |
| Trade Name: | AIDI Dental Implant System |
| Legally Marketed Device | NobelActive™ Internal Connection Implant (K071370) |
| IDI™ Implant System (K081860) |
1. Device Description:
AID! Dental Implant System (AIDI) is a threaded root-form dental implant intended for use (function) in the upper and lower jaw arches to support prosthetic devices, such as an artificial tooth, in order to restore esthetics and chewing function to partially or fully edentulous patients. Also included are straight abutments which provide cemented and screw retained restorative options.
AIDI is an improved version of the predicated IDI Implant System (IDI). AIDI has the same scientific concepts as predicated IDI which include same internal connection design, same internal thread at apical end, same thread design at external surfaces and same surface treatment which is Soluable Blast Media (SBM).
The physical and performance characteristic of AIDI, predicated IDI and predicated NobelActive Dental Implant (NA) includes gradually expanding tapered implant body allowing for alveolar bone expanding and condensing capabilities. The material composition of AIDI and predicated IDI are Titanium ASTM F67 Grade 4 or ASTM F-136 6AL4V ELI. AIDI is also similar to predicated NA Implants in tapered coronal design and hex-cavity internal connection design.
ﺔ ﻧﻴﻮﻳﺎ ﺑ
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4. Nonclinical Test Summary
The nonclinical test data of AIDI Dental Implant System Torque Test Report revealed a high torque strength for AIDI Dental Implants. The predicated IDI™ implant and predicated NobelActive™ dental implant resembled the same torque strength.
5. Clinical Test Summary
No clinical studies are submitted.
6. Conclusion
In Sum, we can conclude that AIDI Dental Implant System (K101755) is safe and effective for its intended use and performs as well as predicated IDI Implant System (K081806) and predicated NobelActive Internal Connection Implant System (K071370) for the following reasons:
- A. The torque strength test data revealed a high torque strength for AIDI Dental Implants. The corque strong IN toolant system and predicated NobelActive™ Internal Connection Implant System resembled the same torque strength.
- B. IDI Implant System (K081806) and NobelActive Internal Connection Implant System (K071370) are substantially equivalent to AIDI dental implant system (K101755) regarding materials, design and technological characteristics.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Dr. William Y.S. Hung Chief Executive Office AIDI BioMedical, LLC 34859 Frederick Street, #105 Wildomar, California 92595
NOV 2 2 2010
Re: K101755
Trade/Device Name: AIDI Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: October 7, 2010 Received: October 14, 2010
Dear Dr. Hung:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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Page 2- Dr. Hung
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Susan Runer
Anthony D. Watson, B.S., M.S., M.B.A. 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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Klo1755
-Indications-for-Use :-
AIDI Dental Implant Systems® (AIDI Fixtures and AIDI Abutments with AIDT Dental implant Systembents intended to be surgically placed in the Sorews) are enabose lower jaw arches to provide support for prosthetic bone of the upper of artificial tooth, in order to restore patient esthetics deviocs, suon ao an arming abutments indicated for both screw and chewing function. Straigrations are included. The implants are indicated for single or multiple unit restorations and can be used in indicator for oingle applications. The device is intended for Splinted and non opinious appress and immediate loading when good primary stability has been achieved and with appropriate occlusal loading.
Over-The-Counter Use Prescription Use x (21 CFR 801 Subpart (Part 21 CFR801 Subpart AND/OR C) D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Susan Rixner
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K101753
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5
K101755
NOV 2 2 2010
2. Indication for Use
AIDI Dental Implant Systems are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetics devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. The device is intended for immediate placement and immediate loading when good primary stability has been achieved and with appropriate occlusal loading.