(84 days)
No
The 510(k) summary describes a physical dental implant device and its intended use, with no mention of software, algorithms, or any technology related to AI or ML.
No
The device is described as an implant for long-term intra-bony applications, designed to provide support for dental restorations. While it aids in the restoration of function, it does not directly treat or cure a disease or condition in the way a therapeutic device typically would.
No
Explanation: The device, Simpler Mini Implants, is described as a long-term intra-bony application intended for dental restorations (implants), not for diagnosing medical conditions.
No
The device description clearly describes physical implants made of materials and with specific dimensions, indicating it is a hardware device, 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 Simpler Mini Implants and Simpler HA Mini Implants are described as devices intended for long-term intra-bony applications in the mandible and maxilla. They are used to provide support for dental restorations in patients with partial or full edentulism. This involves surgical implantation into the bone.
- Lack of Biological Sample Analysis: The description does not mention any analysis of biological samples from the patient. The device is a physical implant placed within the body.
Therefore, the function and application of this device fall outside the scope of in vitro diagnostics. It is a medical device used for surgical and prosthetic purposes.
N/A
Intended Use / Indications for Use
The Simpler Mini Implants (ID SM3002-4) and the Simpler HA Mini Implants (ID SM5002-4) are intended to provide long term intra-bony applications. They are designed for immediate loading when there is good primary stability and an appropriate occlusal load. They may also be used for temporary support for partial and fully edentulous restoration in the mandible and maxilla. They may be used for full or partial edentulism and are used as an option to provide a minimally invasive surgical intervention.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
The HA coated Simpler Mini Implants (K 083886) are identical to the Simpler Mini Implants (K073645) except for the addition of the HA coating to the threaded area of the implants. Natural dentition is composed of a subgingival root and a supragingival crown. For both coated and uncoated mini implant designs tend to minic this structure and transitional implants are no exception. The implant base and the abutment are all in one piece. They are 2.5mm in diameter with a choice of 10, 13 or 15 mm in length for both the Simpler HA mini implants.
For partial and complete edentulism, a retaining a rubber ring acts like a socket to receive the ball on the top of the implant. A soft liner is placed into the patient's denture to adapt around the ball portion of the implant to provide retention to the denture. When seated, the denture rests on the gum tissue.
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
Used in a clinical setting by a qualified dentist.
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): 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.
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
510k:K083886 SUMMARY: THE MINI IMPLANT SYSTEM
Traditional 510(k): Device Summary Submitter: Dr. Harold Bergman, President 659543 BC Ltd. Simpler One Stop #404 1023 Wolfe Ave., Vancouver, BC, V6H 1V6, CANADA 604 736 9747 Fax: Phone 604 736 9890 Dr. Harold Bergman Contact:
Simpler HA Mini Implants Trade Name: Simpler Mini Implants Common Name: Mini Implants. Endosseous Dental Implants. Classification Name:
Legally marketed devices to which S.E. is claimed
K073645 Simpler Mini Implants
K974856 Simpler Threaded Implants K031106 Imtec Sendax MDI and MDI Plus
Description:
The HA coated Simpler Mini Implants (K 083886) are identical to the Simpler Mini Implants (K073645) except for the addition of the HA coating to the threaded area of the implants. Natural dentition is composed of a subgingival root and a supragingival crown. For both coated and uncoated mini implant designs tend to minic this structure and transitional implants are no exception. The implant base and the abutment are all in one piece. They are 2.5mm in diameter with a choice of 10, 13 or 15 mm in length for both the Simpler HA mini implants.
For partial and complete edentulism, a retaining a rubber ring acts like a socket to receive the ball on the top of the implant. A soft liner is placed into the patient's denture to adapt around the ball portion of the implant to provide retention to the denture. When seated, the denture rests on the gum tissue.
Indications for Use
The Simpler Mini Implants (ID S3002-4) and the Simpler HA Mini Implants (ID S5002-4) are intended to provide long term intra-bony applications. They are designed for immediate loading. They may also be used for temporary support for partial and fully edentulous restoration in the mandible and maxillae. They may be used for full or partial edentulism and are used as an option for a minimally invasive surgical intervention.
Other implants with similar indications for use are:
Mini Drive-Lock TM Dental Implants ITI Dental Implants K894593 K894595
IMTEC Sendax MDIs K031106
Nobel Biocare Branemark Implants
The Simpler HA Mini Implant and the Simpler Mini Implant is used in a clinical setting by a qualified dentist. It is expected that the dentist be familiar with placing narrow diameter implants. Patients have the advantage of immediate loading of their prostheses.
Contraindications:
Contraindications customary to the placement of any dental implant may be observed. These include, but are not limited to current local infection, vascular impairment, uncontrolled diabetes, chronic high doses of steroids, clotting disorders, current anticoagulant therapy, metabolic bone disease, and other metabolic or systemic disorders which will affect bone or wound healing. Excessive loading or placement of implants in inadequate bone may result in fracture.
Complications: Possible complications with any oral reconstructive surgery include infection, abscess formation, bone loss, pain soft tissue irregularities and additional complications associated with anesthesia and dental surgery.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with outstretched wings, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, emphasizing the organization's name and national affiliation. The overall design is simple and professional, conveying the department's role in public health and human services.
Public Health Service
JUN 222009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Harold Bergman President 659543 BC Limited Simpler One Stop 404 - 1023 Wolfe Avenue Vancouver, BC CANADA V6H 1V6
Re: K083886
Trade/Device Name: Simpler Mini Implant & Simpler HA Mini Implant Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: January 29, 2009 Received: January 29, 2009
Dear Dr. Bergman:
This letter corrects our substantially equivalent letter of March 23, 2009.
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 (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 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.
2
Page 2 - Dr. Bergman
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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
MSusan Ruan
M. Susan Runner, D.D.S., M.A. Acting Director Divison of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS:
THE MINI IMPLANT SYSTEM
510(k) Number (if known): K083886
Device Name: Simpler Mini Implant & Simpler HA Mini Implant
Indications for Use:
The Simpler Mini Implants (ID SM3002-4) and the Simpler HA Mini Implants (ID SM5002-4) are intended to provide long term intra-bony applications. They are designed for immediate loading when there is good primary stability and an appropriate They may also be used for temporary support for partial and fully occlusal load. edentulous restoration in the mandible and maxilla. They may be used for full or partial edentulism and are used as an option to provide a minimally invasive surgical intervention.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kein Mulvey for MSR
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K 083886