(340 days)
Not Found
No
The document describes a dental implant system and its intended use, device description, and performance testing. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on mechanical properties (torque and fatigue) and clinical history of a predicate device, not on algorithmic performance.
Yes
The device is described as an implant system that provides chewing function to a patient with missing teeth, which directly addresses a health condition (missing teeth) and restores a physiological function (chewing).
No
The device is an implant system used to provide support for prosthetic devices, not to diagnose a condition or disease.
No
The device description clearly states it is a "threaded, endosseous dental implant," which is a physical hardware component, not software.
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 for surgical and restorative applications for placing implants in the mandible and maxilla to support prosthetic devices for chewing function. This is a direct intervention on the patient's body.
- Device Description: The device is described as a threaded, endosseous dental implant. This is a physical implant placed within the bone.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The description of the SIMPLI Simpler Implant System does not involve any such testing of bodily specimens.
Therefore, the SIMPLI Simpler Implant System is a medical device used for surgical implantation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SIMPLI Simpler Implant System is indicated for use in surgical and restorative applications for placement of implants in the mandible and maxilla to provide support for prosthetic devices such as artificial teeth to provide chewing function to a patient with missing teeth. It is indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Product codes
DZE
Device Description
The SIMPLI™ Simpler implant system is a threaded, endosseous dental implant designed to be one piece immediate load as well as delayed load to replace one, several or all missing teeth.
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
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
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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)
Bench Testing: We have bench tested prototypes of the SIMPLI Simpler implants to determine the amount of torque that can be placed on the implants during insertion. Tests indicate that up to 100NCm of torque can be applied without damage to the implant. No other testing has been performed except for the Fatigue tests performed on the predicate Simpler implants that verified the safety of the Implants and abutments.
Clinical Testing: No clinical testing has been performed on the SIMPLI Simpler system. The predicate device, the Simpler System, has been sold and used world wide for over 20 years without any recalls, law suits or non compliance issues. The SIMPLI Simpler Implant System is substantially equivalent to other commercially available Dental Implant Systems and is as safe and effective as the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K083886, K081653, K032351, K080115
Reference Device(s)
Not Found
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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510K Summary
5 2013 APR
Summary: K121281
Submitter: Company Address
Simpler Implant Solutions Inc. 2930 Arbutus St. Vancouver, BC vel 3ya
Contact Person:
Dr. Harold Bergman haroldbergman1@gmail.com 604 736 9890 Telephone 604 736 9747 Fax
Date of Preparation: Trade Name: Common Name: Classification: Product Code:
2013, April 4 SIMPLI™ Simpler Implant System Endosseous Dental Implant Class II (Special Controls) DZE
The SIMPLI™ Simpler implant system is a threaded, endosseous dental implant designed to be one piece immediate load as well as delayed load to replace one, several or all missing teeth. It is equivalent (21 CFR 307.92 (a) (3) to a number of already legally marketed immediate load and devices.
The following Implants are predicates to the SIMPLI Simpler Dental Implant System One Piece O Ring Abutment Implants:
| Simpler Narrow Diameter | K083886 |
|---|---|
| One Piece Crown and Bridge Abutment Implants: | |
| IMTEC Sendax MDI | K081653 |
| Bio Horizons Maestro | K032351 |
| OCO Biomedical Mini | K080115 |
Overall, SIMPLI Simpler has the following similarities to the predicate devices:
- . Same intended use
- . Incorporates the same basic designs and materials
- . Incorporates the same basic surface procedures
- . Uses the same basic surgical protocols
- . Has similar packaging materials and principles
- Sterilized requiring the same intended outcomes.
The difference lies in two areas:
- The design of this implant system incorporates threads which are narrower than the 1. predicates and increases available surface area.
-
- The abutment portion has a slope on one side of the abutment at 25 degrees. This allows any two implants to be placed at a maximum of 50 degrees divergence from each
1
other and still be parallel thereby making it easier for impression taking when restoring the implants.
Indications for Use: The SIMPLI Simpler Implant System is indicated for use in surgical and restorative applications for placement of implants in the mandible and maxilla to provide support for prosthetic devices such as artificial teeth to provide chewing function to a patient with missing teeth. It is indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Bench Testing: We have bench tested prototypes of the SIMPLI Simpler implants to determine the amount of torque that can be placed on the implants during insertion. Tests indicate that up to 100NCm of torque can be applied without damage to the implant. No other testing has been performed except for the Fatigue tests performed on the predicate Simpler implants that verified the safety of the Implants and abutments.
Clinical Testing: No clinical testing has been performed on the SIMPLI Simpler system. The predicate device, the Simpler System, has been sold and used world wide for over 20 years without any recalls, law suits or non compliance issues. The SIMPLI Simpler Implant System is substantially equivalent to other commercially available Dental Implant Systems and is as safe and effective as the predicate devices.
Conclusions: I, Dr Harold Bergman, have personally placed over 10,000 predicate device Simpler implants in clinical practice and have found the system to be reliable and consistently successful when placed within accepted and recommended protocols. After carefully reviewing the literature, testing and examining the other predicate devices, I have every reason to believe the SIMPLI Simpler System will perform as well or better than any of the predicate devices.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 5, 2013
Dr. Harold Bergman Simpler Implant Solutions, Incorporated #404 1023 Wolfe Avenue Vancouver, British Columbia V6H 1V6
Re: K121281
Trade/Device Name: SIMPLI Simpler Dental Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: January 21, 2013 Received: March 20, 2013
Dear Dr. Bergman:
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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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 devicerelated 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 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/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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Kwame O. Ulmer-S for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number: (if known): K12128)
Device Name: SIMPLI Simpler Dental Implants
Indications for Use : The SIMPLI Simpler Implant System is indicated for use in surgical and restorative applications for placement of implants in the mandible and maxilla to provide support for prosthetic devices such as artificial teeth to provide chewing function to a patient with missing teeth. It is also indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Prescription Use _ X (Part 21 CFR 801 Subpart D and/or
Over-The-Counter Use (21 CFR 801 Subpart C)
(PEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Mary S. Runner -S |
|---|
| Susan Runner, DDS, MA |
| 2013.04.05 |
| 11:11:17 -04'00' |
theslology, General Hospital
510(k) Number: K1212
510k Submission SIMPU 2012, April 16