(158 days)
No
The document describes a physical dental implant and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device, an endosseous dental implant, is designed to replace missing teeth, which is a therapeutic function aimed at restoring oral health and function.
No
Explanation: The device description states it is an "endosseous dental implant" used to replace missing teeth, and its function involves implantation and osseointegration. This describes a therapeutic device, not one designed for diagnosis (identifying a disease or condition).
No
The device description explicitly states the device is an "endosseous dental implant" composed of "titanium alloy," clearly indicating it is a physical hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The Tapered Screw-Vent® M Implant is an endosseous dental implant. It is a physical device implanted into the bone of the jaw.
- Intended Use: Its intended use is to replace missing teeth and support dental prosthetics. This is a surgical and restorative procedure, not a diagnostic test performed on a specimen.
The information provided clearly describes a medical device used for surgical implantation, not a diagnostic test performed outside the body.
N/A
Intended Use / Indications for Use
The Tapered Screw-Vent® M Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional 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.
Product codes
DZE
Device Description
The Tapered Screw-Vent® M Implant is an endosseous dental implant. The implant is composed of titanium alloy. 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. The implant contains a 1mm machined collar and small grooves to the top of the implant. In addition, the implant section is tapered with triple-lead threads.
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
No clinical testing was performed. Non-clinical testing was used to support the decision of safety and effectiveness.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
Image /page/0/Picture/0 description: The image shows the logo for Zimmer Dental. The logo consists of a circle with a stylized "Z" inside it. Below the circle, the word "zimmer" is written in a bold, sans-serif font, with a line underneath it. Below that, the word "dental" is written in a smaller, sans-serif font.
Zimmer Dental
510k No.: K111889
A5-1 Page No .:
DEC - 6 2011
Traditional 510(k) PRE-MARKET NOTIFICATION 510(k)
510(k) SUMMARY (21CFR807.92(a))
-
- Submitter's Information:
Name: Zimmer Dental Inc.
- Submitter's Information:
1900 Aston Ave. Address: Carlsbad, CA 92008
Phone: 760-929-4300
Contact: Melissa Burbage
Date Prepared: July 11, 2011
-
- Device Name:
Trade Name: Tapered Screw-Vent® M Implant Regulation Number: 872.3640 Classification Code: DZE Device Classification Name: Endosseous Dentai Implant
- Device Name:
2. Predicate Device(s):
Predicate Device No. 1 Trade Name: Tapered Screw-Vent® T Implant 872.3640 Regulation Number: Classification Code: DZE Device Classification Name: Endosseous Dental Implant
| Predicate Device No. 2 | |
|---|---|
| Trade Name: | Tapered Screw-Vent® Implant System |
| Regulation Number: | 872.3640 |
| Classification Code: | DZE |
| Device Classification Name: | Endosseous Dental Implant |
-
- Device Description:
The Tapered Screw-Vent® M Implant is an endosseous dental implant. The implant is composed of titanium alloy. The implant section is designed for ease of implantation and with greater surface area for
- Device Description:
1900 Aston Avenue Carlsbad, CA 92008 760.929.4300 (ph) 760.431.7811 (fax)
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osseointegration. The implant section surface is treated to facilitate osseointegration. The implant contains a 1mm machined collar and small grooves to the top of the implant. In addition, the implant section is tapered with triple-lead threads.
ട്. Indications for Use:
The Tapered Screw-Vent® M Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional 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.
റ. Device Comparison:
The Tapered Screw-Vent® M Implant is the same as the predicate Tapered Screw-Vent® T Implant and Tapered Screw-Vent® Implant in the implant/abutment connection, implant body design, materials, and manufacturing. This device has been modified to add the machined collar to the top of the implant similar to the predicate Tapered Screw-Vent implant (K061410) and add small grooves on the implant collar identical to the predicate Tapered Screw-Vent® T implant. The new device will feature MTX surface equivalent to existing Zimmer Dental implants. The new implant will be offered in 3.7mm, 4.1mm, 4.7mm and 6.0mm diameters.
Technological Characteristics 7.
| Feature | New Device 1
Tapered Screw-Vent® M | Predicate Device 1
Tapered Screw-Vent® T | Predicate Device 2
Tapered Screw-Vent® |
|----------------------------|-----------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------|
| Implant Interface | Internal Hex | Internal Hex | Internal Hex |
| Implant Lengths | 8, 10, 11.5, 13, 16mm | 8, 10, 11.5, 13, 16mm | 8, 10, 11.5, 13, 16mm |
| Implant Diameters | 3.7, 4.1, 4.7, 6.0mm | 3.7, 4.1, 4.7, 6.0mm | 3.7, 4.1, 4.7, 6.0mm |
| Material | Titanium 6Al-4V | Titanium 6Al-4V | Titanium 6Al-4V |
| Collars | Machined surface and
texture, with grooves | Texture to top with
grooves | Machined surface and
texture |
| Thread Pattern | Triple lead threads,
pattern tightly spaced &
equal | Triple lead threads,
pattern tightly spaced &
equal | Triple lead threads,
pattern tightly spaced &
equal |
| Surface
Characteristics | MTX Surface | MTX Surface | MTX Surface |
2
Tapered Screw-Vent® M Implant
| 510(k) No. | K111889 |
|---|---|
| Page No. | A5-2 |
i
8. Non-Clinical Testing:
The Tapered Screw-Vent M is mechanically similar to the predicate Tapered Screw-Vent implant; both implants have the same internal hexagon interface, triple lead threads of the same size and depth, and the same diameter internal thread. Both are fabricated from the same material.
Both the predicate, Tapered Screw-Vent T, and the new device, Tapered Screw-Vent M, utilize the same lower level drawing for the machined component which was submitted in K101977. They are both made of titanium allov with the same mechanical properties. Both implants have the same MTX grit blasted surface, with the exception of the 0.5mm wide machined collar finish on the Tapered Screw-Vent M implant. Therefore, the Tapered Screw-Vent M is mechanically equivalent to the predicate design and mechanical testing is not necessary.
റ്റ. Clinical Testing
No clinical testing was performed. Non-clinical testing was used to support the decision of safety and effectiveness.
-
- Conclusion
Based on our analysis, the device is substantially equivalent to the predicate and considers the new device is as safe and effective for its intended use and performs as well the predicate device.
- Conclusion
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Melissa Burbage Manager, Regulatory Affairs Zimmer Dental, Incorporated 1900 Aston Avenue Carlsbad, California 92008-7308
DEC - 6 2011
Re: K111889 Trade/Device Name: Tapered Screw-Vent® M Implant Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: October 17, 2011 Received: October 1, 2011
Dear Ms. Burbage:
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.
4
Page 2- Ms. Burbage
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 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.
$
Anthony D. Watson, B.S., M.S., M.B.A. 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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Image /page/5/Picture/0 description: The image shows a logo for Zimmer Dental. The logo features a stylized letter "Z" inside a circle, with the word "zimmer" in bold, sans-serif font below it. Underneath "zimmer" is the word "dental" in a smaller, sans-serif font.
Indications for Use
510(k) Number (if known):
Device Name: Tapered Screw-Vent® M Implant
Indications For Use:
The Tapered Screw-Vent® M Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional 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.
X 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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: k-111889