(123 days)
Not Found
No
The summary describes a physical dental implant and its material properties and dimensions. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a dental implant designed for use in the maxilla or mandible to replace missing teeth, which is a therapeutic purpose.
No
Explanation: The device is an endosseous dental implant designed to replace missing teeth, not to diagnose a condition.
No
The device description clearly states it is an "endosseous dental implant composed of titanium alloy and Trabecular Metal (tantalum)," which are physical materials, not software. The performance studies also focus on mechanical properties like fatigue and compression testing, further indicating a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Zimmer Trabecular Metal Implants are designed for use in the maxilla or mandible to replace missing teeth. This is a surgical implant procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as an endosseous dental implant made of titanium alloy and tantalum. This is a physical implant intended to be placed within the bone.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (blood, urine, tissue, etc.) to diagnose a condition, monitor treatment, or screen for diseases.
IVD devices are used in vitro (outside the body) to examine specimens. This device is used in vivo (inside the body) as a replacement for missing teeth.
N/A
Intended Use / Indications for Use
The Zimmer Trabecular Metal Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional or delayed healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
The 3.7mmD Zimmer Trabecular Metal Implants should be splinted to additional implants when used in the pre-molar region and should not be used in the molar region.
The 4.1mmD Zimmer Trabecular Metal Implants should be splinted to additional implants when used in the molar region.
The 4.1mmD x 8mmL Zimmer Trabecular Metal Implant should be splinted to additional implants when used in the pre-molar region and should not be used in the molar region.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
Trabecular Metal Implant is an endosseous dental implant composed of titanium alloy and Trabecular Metal (tantalum). The implant section is designed for ease of implantation and with greater surface area for osseointegration. The implant section surface is treated to facilitate osseointegration. In addition, the implant section is tapered with triple-lead threads.
The Trabecular Metal Implant family is currently offered in 4.1. 4.7, and 6.0mm diameters in lengths of 8. 10. 11.5. 13. and 16mm. They include two different texturing configurations: full texture to the top of the implant and texture to 0.5mm from the top of the implant. In addition, both texturing configurations of the implant have coronal grooves on the collar to within 0.64mm of the top of the implant similar to the predicate #1 : Trabecular Metal Dental Implant. An additional Trabecular Metal implant with a new diameter of 3.7mmD will be offered in lengths of 10, 11.5, 13 and 16mmL. The implant-abutment interface platform diameter will be offered in a size of 3.5mm. The new device will feature MTX surface equivalent to existing Zimmer Dental implants. The MTX surface is used on the titanium body and is exposed on surfaces apical and coronal to the Trabecular Metal.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxilla or mandible
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 test data was used to support the decision of substantial equivalence. Non-clinical testing consisted of performance of fatigue and compression testing in accordance with the FDA guidance Class II Special Controls Guidance Document: Root-form Dental Implants and Endosseous Dental Implant Abutments. The testing indicates that the device is strong enough to withstand the anticipated forces and demonstrated improvements over the predicate device. Additionally, torque testing was conducted in accordance with internal Zimmer Research Protocols to indicate the strength at the apical tip of the implant is greater than the stress that the implant will see in dense cortical bone.
No clinical testing was performed.
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.
K112160, K113753, K013227, K061410
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.
Not Found
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
1900 Aston Avenue Carlsbad, CA 92008 760.929.4300 (ph) 760.431.7811 (fax)
Traditional 510(k) PRE-MARKET NOTIFICATION 510(k)
510(k) SUMMARY (21CFR807.92(a))
Submitter's Information: 1.
-
Zimmer Dental Inc. Name: Address: 1900 Aston Ave. Carlsbad, CA 92008 760-929-4366 Phone: Contact: Julie Lamothe
Date Prepared: June 18, 2013 -
- Device Name: Trade Name: Regulation Number: Classification Code: Device Classification Name:
Trabecular Metal Implant 872.3640 DZE Implant, Endosseous, Root-Form
- Device Name: Trade Name: Regulation Number: Classification Code: Device Classification Name:
-
ని. Predicate Device(s):
Predicate Device No. 1 Trade Name: 510(k): Regulation Number: Classification Code: Device Classification Name:
Predicate Device No. 2 Trade Name: 510(k): Regulation Number: Classification Code: Device Classification Name: Trabecular ScrewVent X Implant K112160, K113753 872.3640 DZE Implant, Endosseous, Root-Form
Screw Vent Dental Implant K013227, K061410 872.3640 DZE Implant, Endosseous, Root-Form
Device Description: 4.
Trabecular Metal Implant is an endosseous dental implant composed of titanium alloy and Trabecular Metal (tantalum). The implant section is designed for ease of implantation and with greater surface area for osseointegration. The implant section surface is treated to facilitate
NOV 1 9 2013
1
osseointegration. In addition, the implant section is tapered with triple-lead threads.
The Trabecular Metal Implant family is currently offered in 4.1. 4.7, and 6.0mm diameters in lengths of 8. 10. 11.5. 13. and 16mm. They include two different texturing configurations: full texture to the top of the implant and texture to 0.5mm from the top of the implant. In addition, both texturing configurations of the implant have coronal grooves on the collar to within 0.64mm of the top of the implant similar to the predicate #1 : Trabecular Metal Dental Implant. An additional Trabecular Metal implant with a new diameter of 3.7mmD will be offered in lengths of 10, 11.5, 13 and 16mmL. The implant-abutment interface platform diameter will be offered in a size of 3.5mm. The new device will feature MTX surface equivalent to existing Zimmer Dental implants. The MTX surface is used on the titanium body and is exposed on surfaces apical and coronal to the Trabecular Metal.
న్. Indications for Use:
The Zimmer Trabecular Metal Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional or delayed healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
The 3.7mmD Zimmer Trabecular Metal Implants should be splinted to additional implants when used in the pre-molar region and should not be used in the molar region.
The 4.1mmD Zimmer Trabecular Metal Implants should be splinted to additional implants when used in the molar region.
The 4.1mmD x 8mmL Zimmer Trabecular Metal Implant should be splinted to additional implants when used in the pre-molar region and should not be used in the molar region.
6. Device Comparison:
The Zimmer Trabecular Metal Implant is similar to predicate device #2 Zimmer Screw Vent Implant (K013227, K061410), relative to mechanical strength and implant/abutment connection. The 3.7mmD Trabecular Metal device includes an assembly of Trabecular Metal (tantalum) to a titanium allov core similar to predicate device #1, Trabecular Metal Implant (K112160). The threaded portion of the implant will have a tapered body with triple lead thread design, and the Trabecular Metal portion of the implant is cylindrical. The Trabecular Metal is a 3D structure similar to cancellous bone that will allow for bone
2
ingrowth. The new implant will be offered in a 3.7mm diameter in lengths of 10, 11.5, 13 and 16mm.
-
- Technological Characteristics
| Feature | New Device
Zimmer Trabecular Metal
Implant | Predicate 1
Zimmer Trabecular Metal
Implant | Predicate 2
Screw-Vent Dental
Implant |
|----------------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|---------------------------------------------|
| Implant
Interface | Internal Hex | Internal, Hex | Internal Hex |
| Implant Lengths | 10mm, 11.5mm, 13mm,
16mm | 8.0mm, 10mm, 11.5mm,
13mm, 16mm | 8.0mm, 10mm, 13mm,
16mm |
| Implant
Diameters | 3.7mm | 4.1mm, 4.7mm, 6.0mm | 3.3mm, 3.7mm, 4.7mm |
| Material | Titanium 6Al-4V
Tantalum | Titanium 6Al-4V
Tantalum | Titanium 6Al-4V |
| Collars | Machined with grooves or
textured to top with grooves | Machined with grooves or
textured to top with grooves | Machined |
| Thread Pattern | Triple lead threads, pattern
tightly spaced & equal;
partial cylinder type body | Triple lead threads, pattern
tightly spaced & equal;
partial cylinder type body | Single Lead |
| Surface
Characteristics | MTX Surface and
Trabecular Metal TM
(tantalum) | MTX Surface and
Trabecular Metal TM
(tantalum) | MTX Surface and MP-1
HA |
8. Non-Clinical Testing:
Non-clinical test data was used to support the decision of substantial equivalence. Non-clinical testing consisted of performance of fatigue and compression testing in accordance with the FDA guidance Class II Special Controls Guidance Document: Root-form Dental Implants and Endosseous Dental Implant Abutments. The testing indicates that the device is strong enough to withstand the anticipated forces and demonstrated improvements over the predicate device. Additionally, torque testing was conducted in accordance with internal Zimmer Research Protocols to indicate the strength at the apical tip of the implant is greater than the stress that the implant will see in dense cortical bone.
- ರ. Clinical Testing:
3
No clinical testing was performed. Non-clinical testing was used to support the decision of substantial equivalence.
-
- Conclusion:
Based on our analysis, the device is substantially equivalent to the predicate.
- Conclusion:
4
Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized caduceus, a symbol of medicine and health.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 19, 2013
Zimmer Dental Incorporated Dr. Julie Lamothe Manager Regulatory Affairs 1900 Aston Avenue CARLSBAD CA 92008
Re: K132258
Trade/Device Name: Zimmer Dental Trabecular Metal Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: October 18, 2013 Received: October 21, 2013
Dear Dr. Lamothe:
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.
5
Page 2 - Dr. Lamothe
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 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/ResourcesforYou/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,
Image /page/5/Picture/6 description: The image shows the text "Kwame O Ulmer for -s FDA". The text is in a simple, sans-serif font. The word "FDA" is stylized with a decorative border.
Erin Keith Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Page 87 of 87
16.9988
: .' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' '
Indications for Use
K132258 510(k) Number (if known):
. •
Device Name: Zimmer Dental Trabecular Metal Implant System
Indications For Use:
The Zimmer Trabecular Metal Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional or delayed healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
- The 3.7mmD Zimmer Trabecular Metal Implants should be splinted to additional implants . when used in the pre-molar region and should not be used in the molar region.
- The 4.1mmD Zimmer Trabecular Metal Implants should be splinted to additional implants . when used in the molar region.
- The 4.1mmD x 8mmL Zimmer Trabecular Metal Implant should be splinted to additional . implants when used in the pre-molar region and should not be used in the molar region.
× Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpert C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Michae 2013.1