(259 days)
No
The summary describes a dental implant made of titanium with specific surface treatments and geometries. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies focus on mechanical and biological properties, not algorithmic performance.
Yes.
The device is a dental implant intended for surgical placement to provide prosthetic attachment in various dental restorations, thus restoring function and improving the patient's health.
No
Explanation: The device description and intended use indicate that the 3i T3® Short Implants are for surgical placement and prosthetic attachment, functioning as an implant for treatment rather than for diagnosis. There is no mention of the device collecting or analyzing data to identify a condition or disease.
No
The device description clearly states the device is a physical implant made of titanium, 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 the device is for surgical placement in the jaw to provide prosthetic attachment. This is a surgical implant, not a test performed on samples taken from the body.
- Device Description: The description details the physical characteristics of a dental implant made of titanium, not reagents or equipment for analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
The device is a medical device, specifically a dental implant, used for structural support and prosthetic attachment within the body.
N/A
Intended Use / Indications for Use
The 3i T3® Short Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed loading, or with a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
The 3i T3® Short Implants are manufactured from commercially pure titanium and feature a roughened apex and traditional OSSEOTITE® coronal surface. In addition, the implants are offered with or without a nano-scale discrete crystalline deposition (DCD®) calcium phosphate (CaP) surface treatment. The dental implants are basic screw-type designs available in parallel walled body geometries with an external hex connection for mating with associated Biomet 3t" external connection restorative components. The implants are offered in 5.0mm and 6.0 mm diameters and 5.0mm and 6.0mm lengths to accommodate varying patient anatomy. Size appropriate cover screws are provided with each implant.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper or 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)
Non-clinical testing was performed on the worst case subject devices in the form of fatigue testing in accordance with ISO 14807:2007 and FDA guidance. The results were compared to the previously listed predicate devices in K133049. The subject devices met the pre-determined acceptance criteria.
Additional non-clinical testing was performed on the worst case subject devices and the worst case predicate Bicon devices in the form of implant surface area analysis, bone to implant contact analysis and pullout strength analysis. The results of the head testing were compared and it was determined that the subject devices were substantially equivalent to the predicate Bicon devices in all three tests.
Because the subject devices are manufactured out of identical materials and by identical processes, the primary predicate device biocompatibility data was leveraged.
MR compatibility testing was conducted on the worst case cleared Biomet 3i device constructs utilizing multiple material configurations. Testing included RF heating, MR artifacts, displacement force, and torque under static magnetic fields of 1.5 Tesla (1.5T) and 3.0 Tesla (3.0T) in accordance with FDA Guidance Document [Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment], ASTM F2052-06e, ASTM F2213-06, ASTM F2119-07, and ASTM F2182-11a. The results of the testing demonstrated that the Biomet 3i dental implants (inclusive of the subject devices) and restorative devices are considered to be MR Conditional in both 1.5T and 3.0T MR environments.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized representation of a human figure in profile, with three faces overlapping to symbolize the department's focus on people and health. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 20, 2015
Biomet 3i Mr. Chris McKee Regulatory Affairs Manager 4555 Riverside Drive Palm Beach Gardens, Florida 33410
Re: K150571
Trade/Device Name: 3i T3® Short Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: October 15, 2015 Received: October 16, 2015
Dear Mr. McKee:
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.
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 (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 Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Image /page/1/Picture/8 description: The image shows a signature and the name Tina Kiang. The signature is a series of loops and lines, and the name is written in a simple, sans-serif font. Below the name and signature is the letter S with a dash in front of it.
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
к150571 510(k) Number (if known):_
Device Name: 3i T3® Short Implants
Indications for Use:
The 3i T3® Short Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed loading, or with a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.
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 NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
3i T3® Short Dental Implants 510(k) Summary November 20, 2015
| I. | Company: | BIOMET 3i™
4555 Riverside Drive
Palm Beach Gardens, Florida 33410
(561) 776-6923 | |
|----|-------------------------------|--------------------------------------------------------------------------------------------|--|
| | 1 - - 1 - - 1 - - 1 - - 1 - - | 011- 1 / . 17 | |
Contact: Chris McKee Regulatory Affairs/Regulatory Compliance Leader
- Proprietary Trade Name: 3i T3® Short Implants II.
- III. Classification Name: Implant, Endosseous, Root-Form (21 CFR 872.3640)
- IV. Classification: Class II
- V. Product Code(s): DZE
VI. Reason for 510(k)
The purpose of this 510(k) was to expand BIOMET 37's dental implant product offering by adding dental implants with a multi-level surface topography like the existing 3i T3® Ex Hex Dental Implants but with shorter lengths called the 3i T3® Short Implants. In addition, MR compatibility information is being added to the device labeling for Biomet 3i dental implants (inclusive of the subject devices) and restorative devices.
VII. Product Description
The 3i T3® Short Implants are manufactured from commercially pure titanium and feature a roughened apex and traditional OSSEOTITE® coronal surface. In addition, the implants are offered with or without a nano-scale discrete crystalline deposition (DCD®) calcium phosphate (CaP) surface treatment. The dental implants are basic screw-type designs available in parallel walled body geometries with an external hex connection for mating with associated Biomet 3t" external connection restorative components. The implants are offered in 5.0mm and 6.0 mm diameters and 5.0mm and 6.0mm lengths to accommodate varying patient anatomy. Size appropriate cover screws are provided with each implant.
VIII. Indications
The 3i T3" Short Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed loading, or with a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.
IX. Summary of the Technological Characteristics
The subject devices provide additional implant options for connection to existing Biomet 3i™ external hex restorative components. The primary change from the predicate 3i T3" devices in K133049 is the shorter length. The external connection is the same as the other predicate external connection dental implants. The materials, implant body designs, and surface treatments are identical as the listed primary predicate device. The size offerings are also the same as the secondary predicate device.
4
Unlike the primary predicate device, the subject devices are not indicated for immediate loading. The removal of this indication for the subject devices does not alter their intended use described within Section VIII above, as it is only related to the timing in which the implant can be placed into occlusal loading after implantation. The remaining indications for delayed loading are identical to the primary predicate device. Furthermore, the intended use and remaining indications are equivalent to the secondary predicate device which is similar in size. Based on these equivalencies along with those demonstrated through non-clinical testing, the removal of immediate loading from the indications of the subject devices does not raise any new questions of safety or effectiveness.
X. Identification of Legally Marketed Devices The design features, materials, and indications for use of the subject devices are substantially equivalent to Biomet 3i predicate device noted below:
-
3i T3® External Hex Dental Implants (K133049 SE 1/8/2014) ●
The size of the subject devices are substantially equivalent or similar to the secondary predicate device noted below: -
Bicon Short Implant (5.0mm and 6.0mm, K073368 SE 10/10/2008, K062044 SE 11/21/2006 and K042637 SE 11/15/2004)
XI. Discussion of the Non-Clinical Testing
Non-clinical testing was performed on the worst case subject devices in the form of fatigue testing in accordance with ISO 14807:2007 and FDA guidance. The results were compared to the previously listed predicate devices in K133049. The subject devices met the pre-determined acceptance criteria.
Additional non-clinical testing was performed on the worst case subject devices and the worst case predicate Bicon devices in the form of implant surface area analysis, bone to implant contact analysis and pullout strength analysis. The results of the head testing were compared and it was determined that the subject devices were substantially equivalent to the predicate Bicon devices in all three tests.
Because the subject devices are manufactured out of identical materials and by identical processes, the primary predicate device biocompatibility data was leveraged.
MR compatibility testing was conducted on the worst case cleared Biomet 3i device constructs utilizing multiple material configurations. Testing included RF heating, MR artifacts, displacement force, and torque under static magnetic fields of 1.5 Tesla (1.5T) and 3.0 Tesla (3.0T) in accordance with FDA Guidance Document [Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment], ASTM F2052-06e, ASTM F2213-06, ASTM F2119-07, and ASTM F2182-11a. The results of the testing demonstrated that the Biomet 3i dental implants (inclusive of the subject devices) and restorative devices are considered to be MR Conditional in both 1.5T and 3.0T MR environments. This has been reflected in the device labeling.
XII. Conclusions
The subject devices have demonstrated substantial equivalence to the previously listed predicate devices in that they utilize identical materials and fundamental designs, have the same intended use, and performed equivalently in the aforementioned non-clinical testing.