(363 days)
Not Found
No
The summary describes a physical dental implant system and does not mention any software, algorithms, or data processing that would suggest the use of AI/ML.
No
Explanation: This device is an implant system used to provide support for prosthetic devices (artificial teeth), which restores esthetics and chewing function. It is a structural support device, not a therapeutic one that treats or cures a disease or condition.
No
The device is described as an endosseous implant system used to provide support for prosthetic devices, restoring patient esthetics and chewing function. Its purpose is to physically support a prosthetic, not to diagnose a condition.
No
The device description explicitly states it is a "threaded root-form dental implant" and includes physical components like "straight abutments, cover screws, abutment screws, and healing abutments." This indicates it is a physical medical device, not software-only.
Based on the provided information, 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 designed to be surgically placed in the bone to support prosthetic devices. This is a surgical and restorative procedure performed directly on the patient's body.
- Device Description: The description confirms it's a physical implant system with components like fixtures, abutments, and screws.
- 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 implanted inside the body.
N/A
Intended Use / Indications for Use
The newly improved AIDI Dental Implant System (AID) Fixtures and AIDI Abutments with Screws) is made up of endosseous implants imended to be surgically placed in the bone of the upper or lower jaws to provide support for prositietic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Straight abutments indicated for both screw retained and cemented restorations 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 loading when good primary stability has been achieved with the appropriate occlusal loading.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The improved AIDI Dental Implant System is a threaded root-form dental implant intended for use 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), cover screws, abutment screws, and healing abutments.
The AIDI Dental Implant System (current submission) is an improved version of the previously approved AIDI Dental Implant System (K101755). However, the improved AIDI has the same scientific concepts as the predicates IDI Implant System (K081806) and the previous AIDI Dental Implant System (K101755). For instance, they all have the same internal thread in the apical end, the same thread design on external surfaces, and the same surface treatment - Soluble Blast Media (SBM). The subject device and the predicates are all machined from ASTM F-136 Titanium Ti6AL4V ELI. The abutment screws, cover screws, straight abutments, and healing abutments are also machined from the same alloy.
The physical and performance characteristics of the subject device and the predicate devices include a tapered implant body. AIDI dental implants (current submission) have an octagonal interlocking implant/abutment interface. The improved AIDI also has a similar tapered coronal design as the previous AIDI Dental Implant System (K101755).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper or lower jaws
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)
The nonclinical test data of the currently submitted AIDI Dental Implant System Torque Test Report revealed high torque strength for AIDI Dental Implants. The predicates IDI (K081806) implants and previous AIDI implants (K101755) resembled the same torque strength.
No clinical studies were submitted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K123861 DEC 1 2 2013
Image /page/0/Picture/1 description: The image shows the logo for AIDI Biomedical, LLC. The logo features a stylized figure with outstretched arms above the letters "AIDI" in bold, sans-serif font. Below "AIDI" is the text "BIOMEDICAL, LLC" in a smaller, sans-serif font.
AIDI Biomedical, LLC 34859 Frederick St. #105 Wildomar, CA 92595 Tel: (951) 678-9626 Fax: (951) 471-6147
8. 510(k) Summary (21 CFR 807.92)
510(k) Owner: Dr. William Y.S. Hung Chief Executive Officer
-
Address: AIDI Biomedical, LLC 34859 Frederick St. #105 . Wildomar. CA 92595
Telephone: Fax: -
Contact person: Chen Tian QA Manager
-
Date of Summary Preparation:
November 29, 2012
.
(213) 595-9134
(951) 678-9626 (951) 471-6147
Name of device: Dental Implant System
Classification Name: Endosseous dental implant (21 CFR 872.3640, product code DZE) and Endosseous dental implant abutment (21 CFR 872.3630, product code NHA)
- Trade Name: AIDI Dental Implant System
- Classification: II under 872.3640
Predicate devices(2): AIDI Dental Implant System (K101755) IDI Implant System (K081806)
Materials: Implants are made from ASTM F-67 CO Ti Grade 4. Abutments, healing abutments, cover screws, and abutment screws are made from ASTM F-136 Ti6AI4V.
1
1. Device Description:
The improved AIDI Dental Implant System is a threaded root-form dental implant intended for use 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), cover screws, abutment screws, and healing abutments.
The AIDI Dental Implant System (current submission) is an improved version of the previously approved AIDI Dental Implant System (K101755). However, the improved AIDI has the same scientific concepts as the predicates IDI Implant System (K081806) and the previous AIDI Dental Implant System (K101755). For instance, they all have the same internal thread in the apical end, the same thread design on external surfaces, and the same surface treatment - Soluble Blast Media (SBM). The subject device and the predicates are all machined from ASTM F-136 Titanium Ti6AL4V ELI. The abutment screws, cover screws, straight abutments, and healing abutments are also machined from the same alloy.
The physical and performance characteristics of the subject device and the predicate devices include a tapered implant body. AIDI dental implants (current submission) have an octagonal interlocking implant/abutment interface. The improved AIDI also has a similar tapered coronal design as the previous AIDI Dental Implant System (K101755).
2. Indication for Use
The newly improved AIDI Dental Implant System (AIDI Fixtures and AIDI Abutments with Screws) is made up of endosseous implants intended to be surgically placed in the bone of the upper or lower jaws 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 retained and cemented restorations 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 loading when good primary stability has been achieved with the appropriate occlusal loading.
| Subject Device | Predicate Devices | ||
|---|---|---|---|
| Name | AIDI Dental Implant | ||
| System (Current | |||
| Submission) (AIDI | |||
| Internal Fixture and | |||
| Abutments) | AIDI Dental Implant | ||
| System (Previous) | |||
| (AIDI Internal Fixture and | |||
| Abutments) K101755 | IDI Implant Systems | ||
| (IDI Internal Fixtures | |||
| and Abutments) | |||
| K081806 | |||
| Material | Titanium ASTM F67 | ||
| Grade 4 or ASTM F-136 | |||
| 6AL4V ELI | Titanium ASTM F67 | ||
| Grade 4 or ASTM F-136 | |||
| 6AL4V ELI | Titanium ASTM F67 | ||
| Grade 4 or ASTM F- | |||
| 136 6AL4V ELI | |||
| Coronal Design | Tapered Coronal Design | Tapered Coronal Design | No |
3. Technical Characteristics
2
| Internal Screw
| Thread | Yes | Yes | Yes |
|---|---|---|---|
| Implant Body | |||
| Design | Tapered | Tapered | Tapered |
| Implant Body | |||
| Diameter (mm) | 3.3, 3.7 | 3.2, 3.7, 4.7, 5.4 | 3.7, 4.7, 5.4, 6.4 |
| Length (mm) | 8.8~16.0 | 8.8~16.0 | 8.8~16.0 |
| One-Stage | |||
| Surgical | |||
| Procedures | Yes | Yes | No |
| Two-Stages | |||
| Surgical | |||
| Procedures | Yes | Yes | Yes |
| Implant/ | |||
| Abutment | |||
| Interface | Octagonal Interlocking | Hexagonal Interlocking | Hex-Lobe |
| Interlocking | |||
| Surface | |||
| Treatment | Soluble Blast Media | ||
| (Tricalcium Phosphate/ | |||
| Hydroxyapatite, | |||
| conform to ASTM | |||
| F1185-03) | Soluble Blast Media | ||
| (Tricalcium Phosphate/ | |||
| Hydroxyapatite, conform | |||
| to ASTM F1185-03) | Resorbable media | ||
| Blasting (Tricalcium | |||
| Phosphate/ | |||
| Hydroxyapatite, | |||
| conform to ASTM | |||
| F1185-03) | |||
| Gamma | |||
| Sterilized | Yes | Yes | Yes |
| Attachments | Screw-retained | ||
| restoration system | Screw-retained restoration | ||
| system | Screw-retained | ||
| restoration system |
4. Nonclinical Test Summary
The nonclinical test data of the currently submitted AIDI Dental Implant System Torque Test Report revealed high torque strength for AIDI Dental Implants. The predicates IDI (K081806) implants and previous AIDI implants (K101755) resembled the same torque strength.
5. Clinical Test Summary
No clinical studies were submitted.
6. Conclusion
We conclude that our AIDI Dental Implant System (current submission) is substantially equivalent for its intended use and performs as well as the predicates IDI Implant System (K081806) and AIDI Dental Implant System (K101755):
3
- A. The torque strength test data revealed high torque strength for AIDI Dental Implants (current submission). The predicate IDI implant system (K081806) and predicate AIDI Dental Implant System (K101755) resembled the same torque strength.
- B. The newly improved AIDI dental implant system is substantially equivalent in terms of materials, design, and technical characteristics to the IDI Implant System (K081806) and AIDI Dental Implant System (previous) (K101755)
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo of the Department of Health & Human Services - USA. The logo features a stylized human figure with outstretched arms, representing care and protection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is printed to the right of the logo.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 12, 2013
AIDI Biomedical, LLC Chen Tian Quality Assurance Manager 34859 Frederick Street, #105 Wildomar, CA 92595
Re: K123861
Trade/Device Name: AIDI Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: November 15, 2013 Received: December 2, 2013
Dear Mr. Tian:
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.
5
Page 2 - Mr. Tian
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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/McdicalDevices/Safety/ReportaProblem/dcfault.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/Industrv/default.htm.
Sincerely vours.
Tejashri Purohit-Sheth, M.D.
Clinical Deputy Director
DAGRID
FOR
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Image /page/6/Picture/0 description: The image shows a logo for AIDI Biomedical, LLC. The logo features a stylized emblem above the text "AIDI" in large, bold letters. Below "AIDI" is the text "BIOMEDICAL, LLC" in a smaller font. The emblem appears to be a shield with wings and a flame-like object on top.
AIDI Biomedical. L.C. 34859 Frederick St. #105 Wildomar. CA 92595 Tel: (951) 678-9626 Fax: (951) 471-6147
7. Indications for Use
Device Name: AIDI Dental Implant System
Indications for Use:
The newly improved AIDI Dental Implant System (AID) Fixtures and AIDI Abutments with Screws) is made up of endosseous implants imended to be surgically placed in the bone of the upper or lower jaws to provide support for prositietic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Straight abutments indicated for both screw retained and cemented restorations 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 loading when good primary stability has been achieved with the appropriate occlusal loading.
Prescription use: _ > (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use: (2) CFR 801 Subpart C)
PLEASE DO NOT WRITE BEEOW THIS LINE: CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH. Office of Device Evaluation (ODE)
Mary S. Runner -S
Susan Runner DDS, MA 2013.12.12
08:58:39-05'00'