(87 days)
Not Found
No
The 510(k) summary describes a physical dental implant and does not mention any software, algorithms, or data processing capabilities that would suggest the use of AI or ML.
Yes.
The device is an implant designed to replace missing teeth, which directly addresses a health issue and aims to restore function, thus serving a therapeutic purpose.
No
The device description indicates it is a dental implant designed to replace missing teeth, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states the implants are composed of titanium alloy and are physical endosseous dental implants, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description: The provided text describes a dental implant, which is a physical device surgically placed into the jawbone to support a dental prosthesis. It is a medical device used in vivo (within the body), not in vitro (in a test tube or laboratory setting).
- Intended Use: The intended use is to replace missing teeth and support dental prostheses, which is a structural and functional purpose within the body. It does not involve analyzing biological samples for diagnostic information.
The description clearly indicates a surgical implant for dental restoration, which falls under the category of medical devices, but not specifically IVDs.
N/A
Intended Use / Indications for Use
The Tapered Screw-Vent®T 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 Tapered Screw-Vent® P Implants are designed for use in the maxilla or mandible for loading after a conventional healing period. Implants may be used to replace one or more missing teeth.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
The Tapered Screw-Vent® T Implant is an endosseous dental implant. The implant is composed of titanium alloy. The implant section is designed for ease if 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® P Implant is an endosseous dental implant. The implant is composed of titanium alloy and Cancellous-Structured Titanium (CSTi) coating. The implant section is designed for ease of implantation and with greater surface area for osseointegration. The CSTi coating is designed to allow for bone ingrowth. The implant section surface is treated to facilitate osseointegration. 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical test summary:
The new devices have been subjected to bench testing to determine conformance to performance specifications and requirements taking account of its intended use as a dental implant system and following all indications set out in FDA Document "Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments".
Functional laboratory testing preformed in foreseeable operating conditions showed correct operation of the device per its intended use.
Clinical test summary:
No clinical studies were conducted to evaluate the performance of this device.
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.
K011028, K953101, K013227, K061410, K072589, K062566, K962576
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
Image /page/0/Picture/0 description: The image shows the logo for Zimmer Dental. The logo features a stylized letter Z inside of a circle. Below the circle is the word "zimmer" in a bold, sans-serif font, with a line underneath it, and the word "dental" in a smaller, sans-serif font below the line.
| Zimmer Dental |
|---|
| --------------- |
1900 Aston Avenue Carlsbad. CA 92008 760.929.4300 (ph) 760.431.7811 (fax)
510k No .:
A5-1 Page No .:
2010
OCT 1
10/880
Traditional 510(k) PRE-MARKET NOTIFICATION 510(k)
510(k) SUMMARY (21CFR807.92(a))
-
- Submitter's Information:
Zimmer Dental Inc. Name:
- Submitter's Information:
1900 Aston Ave.
1900 Aston Ave. Address: Carlsbad, CA 92008
760-929-4300 Phone:
Contact: Melissa Burbage
Date Prepared: June 29, 2010
-
- Device Name:
Tapered Screw-Vent® T Implant and Tapered Screw-Vent® P Implant
- Device Name:
Device Classification Name: Endosseous Dental Implant
2. Predicate Device(s):
- a. Zimmer Dental Tapered Screw-Vent® Implant System
- b. NobelReplace Tapered Conical Connection
- i. 510(k) Number: K062566
- c. Spline X Implant
- i. 510(k). Number: K962576
4. Device Description:
The Tapered Screw-Vent® T Implant is an endosseous dental implant. The implant is composed of titanium alloy. The implant section is designed for ease if 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® P Implant is an endosseous dental implant. The implant is composed of titanium alloy and Cancellous-Structured Titanium (CSTi) coating. The implant section is designed for ease of implantation and
1
| 510(k) No. | K101880 |
|---|---|
| Page No. | A5-2 |
with greater surface area for osseointegration. The CSTi coating is designed to allow for bone ingrowth. The implant section surface is treated to facilitate osseointegration. In addition, the implant section is tapered with triple-lead threads.
5. Indications for Use:
The Tapered Screw-Vent® T 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 Tapered Screw-Vent® P Implants are designed for use in the maxilla or mandible for loading after a conventional healing period. Implants may be used to replace one or more missing teeth.
6. Device Comparison:
The Tapered Screw-Vent® T Implant is the same as the predicate Tapered Screw-Vent Implant in the implant/abutment connection, implant body design, materials, and manufacturing. This device has been modified to add the MTX texture to the top of the implant and add small grooves on the implant collar similar to the predicate NobelReplace Tapered implant. The new device will feature hydroxylapatite coating, hydroxylapatite coating with additional Zimmer Dental MP-1® processing, or MTX surface equivalent to existing Zimmer Dental implants. The new implant will be offered in 4.7mm and 6.0mm diameters.
The Tapered Screw-Vent® P implant is the same as the predicate Tapered Screw-Vent® implant in the implant/abutment connection, general implant body design, materials, and manufacturing. The modifications to this device include addition of MTX texture to the top of the implant and the addition of small grooves to the implant collar similar to the predicate NobelReplace Tapered implant. Another modification includes a porous surface created using Cancellous-Structured Titanium (CSTi). This is the same porous surface on the predicate Spline X implant (K962576). The new implant will be offered in 4.7mm and 6.0mm diameters.
7. Basis for Substantial Equivalence:
The new devices are substantially equivalent to the predicate devices, the indications for Tapered Screw-Vent® T Implant are the same as the Tapered increations for the indications for the Tapered Screw-Vent® P implant have been reduced and only have indications for use in the maxilla or mandible for loading after a conventional healing period. The new devices have the
2
| 510(k) No. | K101880 |
|---|---|
| Page No. | A5-3 |
same technological characteristics as the previously cleared predicated devices, and it can be demonstrated that the devices are as safe and effective as the predicate devices. The new devices do not raise any different questions regarding safety and effectiveness as compared to the predicate devices. The Tapered Screw-Vent® T Implant and Tapered Screw-Vent® P Implant, as designed and manufactured, is as safe and effective as the predicate devices and therefore determined substantially equivalent to the referenced predicate devices.
7.1 Non-clinical test summary:
The new devices have been subjected to bench testing to determine conformance to performance specifications and requirements taking account of its intended use as a dental implant system and following all indications set out in FDA Document "Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments".
Functional laboratory testing preformed in foreseeable operating conditions showed correct operation of the device per its intended use.
7.2 Clinical test summary:
No clinical studies were conducted to evaluate the performance of this device.
8. Conclusion:
We believe that the Tapered Screw-Vent® T Implant and Tapered Screw-Vent® P Implant constitute a safe, reliable and effective dental implant, meeting all the declared requirements of the intended use. The devices present no new adverse health effects or safety risks to patients when used as intended.
We conclude that the new devices are safe and effective for the indications for use, and based on the information included in this submission, we believe that substantial equivalence of the proposed devices with the legally marketed predicate devices may be established.
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Image /page/3/Picture/0 description: The image shows a logo for the Department of Health & Human Services - USA. The logo is circular and contains the department's symbol, which is a stylized representation of a human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle. A dotted line is also present in the image.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DCT 1 2010
Ms. Melissa Burbage Regulatory Affairs Manager Zimmer Dental Incorporated 1900 Aston Avenue Carlsbad, California 92008-7308
Re: K101880
Trade/Device Name: Tapered Screw-Vent® T Implant and Tapered Screw-Vent® P Implant Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: September 3, 2010 Received: September 14, 2010
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.html 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. Below the circle, the word "zimmer" is written in a bold, sans-serif font. Underneath "zimmer", the word "dental" is written in a smaller, less bold font.
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Tapered Screw-Vent® T Implant and Tapered Screw-Vent® P Implant
Indications For Use:
The Tapered Screw-Vent®T 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 Tapered Screw-Vent® P Implants are designed for use in the maxilla or mandible for loading after a conventional healing period. Implants may be used to replace one or more missing teeth.
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)
Susan Runos
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesion Devices Division of Andolinoon - 30.
Infection Control, Dental Devices
510(k) Number: K101880