(253 days)
Not Found
No
The 510(k) summary describes a dental implant and its physical characteristics, materials, and clinical studies. There is no mention of AI, ML, image processing, or any software-based analytical capabilities that would suggest the use of AI/ML.
Yes
The device is a dental implant designed to replace missing teeth, which is a therapeutic function aimed at restoring the patient's oral function and aesthetics.
No
The device is an endosseous dental implant designed for replacing missing teeth, not for diagnosing medical conditions.
No
The device description clearly states the device is an endosseous dental implant composed of titanium alloy and Trabecular metal, which are hardware components.
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 designed for use in the maxilla or mandible to replace missing teeth. This is a surgical device implanted directly into the body.
- Device Description: The description details the physical composition and design of a dental implant, which is a physical object used in a surgical procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a prosthetic.
N/A
Intended Use / Indications for Use
The Tapered Screw-Vent® X 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. The 4.1mmD Tapered Screw Vent X Implants should be splinted to additional implants when used in the posterior region.
Product codes
DZE
Device Description
The Tapered Screw-Vent® X Implant is an endosseous dental implant. The implant is composed of titanium alloy and Trabecular metal. 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 Tapered Screw-Vent X implants will be offered in 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 will have coronal grooves on the collar to within 0.64mm of the top of the implant similar to the predicate Tapered Screw-Vent P Dental implant. The implant/abutment interface platform diameter will be offered in sizes of 3.5mm, 4.5mm, or 5.7mm depending on the outside implant thread diameter. 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 Testing: Testing was performed following "Guidance for Industry and FDA Staff -Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments." Performance testing demonstrated that the device performs appropriately for the proposed indications for use.
Clinical Testing: A prospective clinical study was conducted to evaluate the performance of this device within a controlled population that included implantation within the posterior region only and a two week final restoration immediate load protocol with a 6-month end point. A second, longitudinal data collection study was initiated to gather data on the routine placement and functioning within normal clinical conditions. This population included normal patients and subjects with elevated risk factors that were excluded from the controlled study, such as: alcoholics, substance abusers, mentally unstable, smokers, osteoporotics, uncontrolled diabetics, parafunctional habits, dental or oral infections, and bone graft patients. No device related adverse events were reported in either study to date.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K101880, K011028, K953101, K013227, K061410, K072589
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
Image /page/0/Picture/0 description: The image shows the logo for Zimmer Dental. The logo consists of a circle with a stylized letter "Z" inside it. Below the circle, the word "zimmer" is written in a bold, sans-serif font, and below that, the word "dental" is written in a smaller, serif font.
Zimmer Dental
1900 Aston Avenue Carlsbad, CA 92008 760.929.4300 (ph) 760.431.7811 (fax)
510k No.: K113753
Page No .: . A5-1
Traditional 510(k) PRE-MARKET NOTIFICATION 510(k)
AUG 30 2012
510(k) SUMMARY (21CFR807.92(a))
1. Submitter's Information:
Zimmer Dental Inc. Name:
1900 Aston Ave. Address: Carlsbad, CA 92008
760-929-4300 Phone:
Jeremy Markovich Contact:
Date Prepared: December 19, 2011
-
- Device Name: Tapered Screw-Vent®X Implant Trade Name: K112160 510(k) Number: 872.3640 Regulation Number: DZE Classification Code: Device Classification Name: Endosseous Dental Implant
3. Predicate Device(s):
Predicate Device No. 1 Zimmer Dental Tapered Screw-Vent® P Implant Trade Name: 510(k) Number: K101880 872.3640 Requlation Number: Classification Code: DZE Endosseous Dental Implant Device Classification Name:
Predicate Device No. 2 Zimmer Dental Tapered Screw-Vent® Implant Trade Name: System . K011028 / K953101 / K013227 / K061410 / 510(k) Number: K072589 Regulation Number: 872.3640 DZE Classification Code: Endosseous Dental Implant Device Classification Name:
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Page No.
4. Device Description:
The Tapered Screw-Vent® X Implant is an endosseous dental implant. The implant is composed of titanium alloy and Trabecular metal. 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 Tapered Screw-Vent X implants will be offered in 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 will have coronal grooves on the collar to within 0.64mm of the top of the implant similar to the predicate Tapered Screw-Vent P Dental implant. The implant/abutment interface platform diameter will be offered in sizes of 3.5mm, 4.5mm, or 5.7mm depending on the outside implant thread diameter. 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.
5. Indications for Use:
The Tapered Screw-Vent® X 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. The 4.1mmD Tapered Screw Vent X Implants should be splinted to additional implants when used in the posterior region.
Device Comparison: હ.
The Tapered Screw-VentX implant is substantially equivalent to Zimmer's Tapered Screw-Vent implant. Both implants have the same friction fit internal hexagon connection and use the same prosthetic components to restore the implant. Both implants feature triple lead threads that taper inwardly from the coronal to the apical end of the implant (the overall taper for both of the implants are 2 degrees). Both implants have apical flutes that allow the implant to self tap into the osteotomy. Similar to the Tapered Screw-Vent®, the Tapered Screw-Vent® X is offered in diameters from 4.1, 4.7, and 6.0mmD (Tapered Screw-Vent® is also offered in 3.7mmD) and in lengths 8, 10, 11.5, and 13mmL (Tapered Screw-Vent® is also offered in 16mmL) The Tapered
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2
Tapered Screw-Vent® X Implant
Page No.
Screw-Vent® X and Tapered Screw-Vent® all use identical surgical instrumentation and an identical surgical protocol.
7. Technological Characteristics
| Feature | Subject Device | Predicate Device 1 | Predicate Device 2 |
|---|---|---|---|
| Tapered Screw-Vent® X | Tapered Screw-Vent® P | Tapered Screw-Vent® | |
| Implant Interface | Internal Hex | Internal Hex | Internal Hex |
| Implant Lengths | 8, 10, 11.5, 13mm | 10, 11.5, 13, 16mm | 8, 10, 11.5, 13, 16mm |
| Implant Diameters | 4.1, 4.7, 6.0mm | 4.7, 6.0mm | 3.7, 4.1, 4.7, 6.0mm |
| Material | Titanium 6Al-4V | Titanium 6Al-4V | Titanium 6Al-4V |
| Collars | Machined with grooves or | ||
| texture to top with | |||
| grooves | Machined with grooves or | ||
| texture to top with | |||
| grooves | Machined with grooves or | ||
| texture to top with | |||
| grooves | |||
| Thread Pattern | Triple lead threads, | ||
| pattern tightly spaced & | |||
| equal; partial cylinder | |||
| type body | Triple lead threads, | ||
| pattern tightly spaced & | |||
| equal; partial cylinder | |||
| type body | Triple lead threads, | ||
| pattern tightly spaced & | |||
| equal | |||
| Surface | |||
| Characteristics | MTX Surface | ||
| and Trabecular MetalTM | |||
| (tantalum) | MTX Surface | ||
| and CSTiTM coating | MTX Surface, or HA | ||
| Coated, or MP-1® HA | |||
| Coated |
8. Non-clinical Testing
Testing was performed following "Guidance for Industry and FDA Staff -Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments." Performance testing demonstrated that the device performs appropriately for the proposed indications for use.
9. Clinical Testing
A prospective clinical study was conducted to evaluate the performance of this device within a controlled population that included implantation within the posterior region only and a two week final restoration immediate load protocol with a 6-month end point.
A second, longitudinal data collection study was initiated to gather data on the routine placement and functioning within normal clinical conditions. This population included normal patients and subjects with elevated risk factors that were excluded from the controlled study, such as: alcoholics, substance abusers, mentally unstable, smokers,
3
Tapered Screw-Vent®X Implant
510(k) No. K113753 Page No. A5-4
osteoporotics, uncontrolled diabetics, parafunctional habits, dental or oral infections, and bone graft patients.
No device related adverse events were reported in either study to date.
10. Conclusion
Based on our analysis, the device is substantially equivalent to the predicates and it is considered that the new device is as safe and effective for its indications for use.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing-like shapes extending to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG 30 2012
Mr. Jeremv Markovich Seinor Regulatory Affairs Specialist Zimmer Dental, Incorporated 1900 Aston Ave. Carlsbad, California 92008
Re: K113753
Trade/Device Name: Tapered Screw-Vent® X Implant Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: August 24, 2012 Received: August 27, 2012
Dear Mr. Markovich:
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
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 (reporting or increments 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,
Nh for
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/6/Picture/0 description: The image shows a logo with a stylized letter 'Z' inside a circle. Below the circle, the word 'zimmer' is written in a sans-serif font. Underneath 'zimmer', the word 'dental' is written in a smaller, slightly italicized font.
A4-1
Tapered Screw-Vent® X Implant
Indications for Use
KII3753
510(k) Number (if known):
Device Name: Tapered Screw-Vent® X Implant
Indications For Use:
The Tapered Screw-Vent® X 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. The 4.1mmD Tapered Screw Vent X Implants should be splinted to additional implants when used in the posterior region.
× 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)
Super Rese
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
510(k) Number: K113753