(259 days)
No
The summary describes a dental implant and does not mention any AI or ML components or functionalities.
No.
The device is described as a dental implant, which is a prosthetic device for tooth replacement, not a therapeutic device designed to treat a medical condition.
No
The device is described as an implant, which is a therapeutic device, not a diagnostic one. Its intended use is to support dental restorations, not to diagnose a condition.
No
The device description clearly states it is a "one piece endosseous dental implant," which is a physical hardware device.
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 intended to support restorations in the mouth (maxillary and mandibular arches). This is a surgical implant, not a device used to examine specimens from the human body.
- Device Description: The description confirms it's a "one piece endosseous dental implant," which is a physical device implanted into bone.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions through in vitro analysis, or any other activities typically associated with IVD devices.
IVD devices are used outside the body to examine specimens and provide information about a person's health. This device is implanted inside the body for structural support.
N/A
Intended Use / Indications for Use
The Champions Implants MIMI 1-Piece Precision Implant is intended to support single or multi-unit restorations in both long-term and temporary applications throughout the maxillary and mandibular arches. The MIMI 1-Piece Precision Implant is indicated for immediate loading when there is good primary stability and an appropriate occlusal load.
The MIM1 1-Piece Precision Implants have diameters from 4,0 to 4,5mm and are available in length of 10 to 16mm.
Product codes
DZE
Device Description
The MIM® 1-Piece Precision Implant is a one piece endosseous dental implant. The thread lengths are 10mm to 16mm. The diameters are 4,0mm and 4,5mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary and mandibular arches
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
Champions Implants GmbH
Image /page/0/Picture/1 description: The image shows a stylized globe surrounded by a circular border. Four stars are spaced around the lower-left quadrant of the border. The globe depicts the continents of Europe, Africa, and Asia. The image is black and white.
JAN - 7 2010
K 091182
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS IN ACCORDANCE WITH SMDA OF 1990
DATE OF APPLICATION: 2009, April 15
Submitted by:
ﺎﻧﺘﻬﺎ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ
Champions Implants GmbH Bomheimer Landstrasse 8 55237 Flonheim Germany Tel.: +49 (0) 6734 6991 Fax: +49 (0) 6734 1053 E-Mail: info@champions-implants.com Homepage: www.champions-implants.com
1. Device Description
Trade Name: MIMI® 1-Piece Precision Implant Common Name: Dental Implant System
The MIM® 1-Piece Precision Implant is a one piece endosseous dental implant. The thread lengths are 10mm to 16mm. The diameters are 4,0mm and 4,5mm.
2. Classification
| Device: | Dental Implant System | |
|---|---|---|
| Panel: | 872 | |
| Product Code: | DZE | |
| Device Class: | 2 | |
| Regulation Number: | 3640 |
E:\Dr. Nedjat\FDA\05 510k Summary or 510k Statement\510(k) Summary-091007.docx
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Image /page/1/Picture/1 description: The image shows a logo with a stylized globe surrounded by a ring and four stars. The globe depicts a landmass resembling Europe, Africa, and Asia. The stars are evenly spaced around the left side of the ring, adding a decorative element to the design. The logo is rendered in black and white, with the landmass and stars appearing in solid black against a white background.
3. INTENDED USE
ﻣﺮﺗ
The Champions Implants MIMI 1-Piece Precision Implant is intended to support single or multi-unit restorations in both long-term and temporary applications throughout the maxillary and mandibular arches. The MIMI 1-Piece Precision Implant is indicated for immediate loading when there is good primary stability and an appropriate occlusal load.
4. SUBSTANTIAL EQUIVALENCE
- . The MIM® 1-Piece Precision Implant System is substantially equivalent to the Zimmer One-Piece Implant, 3,7mm and 4,7mm, K063523.
5. BIOCOMPATIBILITY
The biocompatibility is guaranteed by fulfilling the requirements of ISO 5832-2:1999, ISO 5832-3-3:1996, ISO 5832-11:1994 and is also used in following 510(k):
- . K063523
Champions Implants GmbH's Dental Implant Screws are only made out of the in ISO 5832-2:1999, ISO 5832-3-3:1996 and ISO 5832-11:1994 mentioned Raw Materials.
6. STERILIZATION
Champions Implants GmbH delivers all MM® 1-Piece Precision Implant Screws in sterile conditions. The sterilization process is validated based on ISO 11137:2006.
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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 the department's name encircling a stylized graphic of an eagle or bird-like figure. The text is arranged in a circular fashion around the graphic. The graphic is a series of three overlapping profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Champions Implants GmbH Mr. Marcus Weinacker CEO MZQ Managementberatung Jahnstrasse 14 Tuningen, Baden-Wuerttemberg GERMANY 78609
JAN - 7 2010
Re: K091182
Trade/Device Name: Champion Implants MIMI 1-Piece Precision Implant Regulation Number: 21CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: December 18, 2009 Received: December 23, 2009
Dear Mr. Weinacker:
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.
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- Mr. Weinacker
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
for
Anthony D. Watson, BS, MS, MBA 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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Indications for Use
510(k) Number (if known): K091182
Device Name: Champions Implants MIMI 1-Piece Precision Implant
Indications For Use:
The Champions Implants MIMI 1-Piece Precision Implant is intended to support single or multi-unit restorations in both long-term and temporary applications throughout the maxillary and mandibular arches. The MIMI 1-Piece Precision Implant is indicated for immediate loading when there is good primary stability and an appropriate occlusal load. The MIM1 1-Piece Precision Implants have diameters from 4,0 to 4,5mm and are available in length of 10 to 16mm.
Prescription Use _X (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 IF NEEDED9
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rei Mchey for MSR
(Division Sign-Off) Division of Anasthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K091182
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