(431 days)
Not Found
No
The 510(k) summary describes a standard dental implant made of titanium alloy with specific geometric features. There is no mention of AI, ML, image processing, or any data-driven algorithms in the intended use, device description, or any other section.
Yes
The device is described as restoring the patient's chewing function and is used in surgical and restorative applications.
No
The device, ARDS dental implants, is described for surgical and restorative applications to support prosthetic devices and restore chewing function, indicating a therapeutic or restorative purpose, not a diagnostic one.
No
The device description explicitly states that the device is made from Titanium alloy and describes its physical characteristics and packaging, indicating it is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device description and intended use: The description clearly states that the ARDS dental implants are physical devices made of titanium alloy, intended for surgical implantation into the bone of the jaw to support prosthetic devices. This is a surgical and restorative procedure performed directly on the patient's body, not a test performed on a sample outside the body.
Therefore, the ARDS dental implant falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ARDS dental implants are indicated for use in surgical and restorative applications for placement in the bone of the upper and lower jaw to provide support for prosthetic devices in order to restore the patient's chewing function. ARDS dental implants are indicated for two-stage surgery.
Product codes
DZE, NHA
Device Description
ARDS implants are made from Titanium allov. The ARDS implants geometrical shape is characterized by altering drilling profile, with double thread at the upper part that change to one thread at the lower part, which increases its surface, and as a result, increases in the preliminary contact surface with the bone. The ARDS dental implants are : S type: Internal hex implants, length 10/13 mm, diameter 3.75/4.5 mm, with double thread at the upper part that goes over in a single thread at the lower part. S implant types are supplied sterile in a double vial system, inside a plastic box which includes the covering screw and the Instructions For Use. The abutments are for single use only and supplied non-sterile. The tools are reusable and supplied non-sterile, they must be sterilized by autoclave before use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone of the upper and 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
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
§ 872.3640 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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, featuring a stylized human figure. To the right of the HHS logo is the FDA logo, which includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are placed side by side, indicating a connection between the two organizations.
June 10, 2019
Ards, Limited, RAC & CQE George Hattub Senior Staff Consultant Medicsense, USA 291 Hillside Avenue Somerset, Massachusetts 02726
Re: K071803
Trade/Device Name: ARDS Dental Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: Class II Product Code: DZE, NHA Dated: August 12, 2008 Received: August 14, 2008
Dear George Hattub:
This letter corrects our substantially equivalent letter of September 05, 2008.
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 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration. Iisting 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Andrew I. Steen -S
for Srinivas Nandkumar, Ph.D. Acting Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known):
Device Name: ARDS Dental Implants
Indications For Use: ARDS dental implants are indicated for use in surgical and restorative applications for placement in the bone of the upper and lower jaw to provide support for prosthetic devices in order to restore the patient's chewing function. ARDS dental implants are indicated for two-stage surgery.
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)
Suan Suape
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of 1
510(k) Number: K071833
3
510(k) Summary of Safety & Effectiveness
Ko71803
Pursuant to CFR 807.92, the following 510(k) Summary is provided:
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- (a) Submitter George J. Hattub Address: MedicSense, USA 291 Hillside Avenue Somerset, MA 02726 www.medicsense.com SEP - 5 2008 1. (b) ARDS, Ltd. Manufacturer 4 Hasikma St. Address: Rishon Lezion, Israel 75201 Mfa. Phone: 972-3-969-0954 Contact Person: Dr. Uri Arny, CEO Date: March 7, 2008 2. Device & Endosseous Dental Implant, Class 2, Product Code DZE, 21 CFR 872.3640 Classification Name: ARDS Dental Implants 3. Predicate Device: Alpha Bio Dental Implant System (K063364) 4. Description: ARDS implants are made from Titanium allov. The ARDS implants geometrical shape is characterized by altering drilling profile, with double thread at the upper part that change to one thread at the lower part, which increases its surface, and as a result, increases in the preliminary contact surface with the bone. The ARDS dental implants are : S type: Internal hex implants, length 10/13 mm, diameter 3.75/4.5 mm, with double thread at the upper part that goes over in a single thread at the lower part. S implant types are supplied sterile in a double vial system, inside a plastic box which includes the covering screw and the Instructions For Use. The abutments are for single use only and supplied non-sterile. The tools are reusable and supplied non-sterile, they must be sterilized by autoclave before use. 5. Intended Use: ARDS dental implants are indicated for use in surgical and restorative applications for placement in the bone of the upper and lower jaw to provide support for prosthetic devices in order to restore the patient's chewing function. ARDS dental implants are indicated for two-stage surgery. 6. Comparison of With respect to technology and intended use, the ARDS dental implants are Technological substantially equivalent to its predicate device which is the Alpha Bio Dental Characteristics: Implant System. The primary differences are propriety in nature. Based upon its testing results, ARDS believes these differences do not raise additional safety of efficacy concerns.
Revised March 9, 2008
- (a) Submitter George J. Hattub Address: MedicSense, USA 291 Hillside Avenue Somerset, MA 02726 www.medicsense.com SEP - 5 2008 1. (b) ARDS, Ltd. Manufacturer 4 Hasikma St. Address: Rishon Lezion, Israel 75201 Mfa. Phone: 972-3-969-0954 Contact Person: Dr. Uri Arny, CEO Date: March 7, 2008 2. Device & Endosseous Dental Implant, Class 2, Product Code DZE, 21 CFR 872.3640 Classification Name: ARDS Dental Implants 3. Predicate Device: Alpha Bio Dental Implant System (K063364) 4. Description: ARDS implants are made from Titanium allov. The ARDS implants geometrical shape is characterized by altering drilling profile, with double thread at the upper part that change to one thread at the lower part, which increases its surface, and as a result, increases in the preliminary contact surface with the bone. The ARDS dental implants are : S type: Internal hex implants, length 10/13 mm, diameter 3.75/4.5 mm, with double thread at the upper part that goes over in a single thread at the lower part. S implant types are supplied sterile in a double vial system, inside a plastic box which includes the covering screw and the Instructions For Use. The abutments are for single use only and supplied non-sterile. The tools are reusable and supplied non-sterile, they must be sterilized by autoclave before use. 5. Intended Use: ARDS dental implants are indicated for use in surgical and restorative applications for placement in the bone of the upper and lower jaw to provide support for prosthetic devices in order to restore the patient's chewing function. ARDS dental implants are indicated for two-stage surgery. 6. Comparison of With respect to technology and intended use, the ARDS dental implants are Technological substantially equivalent to its predicate device which is the Alpha Bio Dental Characteristics: Implant System. The primary differences are propriety in nature. Based upon its testing results, ARDS believes these differences do not raise additional safety of efficacy concerns.