(20 days)
Not Found
No
The summary describes a physical dental implant and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as an endosseous dental implant designed to replace missing teeth, which is a therapeutic function.
No
The description states the device is an implant used to replace missing teeth, indicating a therapeutic or restorative function, not a diagnostic one.
No
The device description clearly states it is an endosseous dental implant made of titanium alloy, which is a physical hardware component.
Based on the provided information, 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.
- Device Description: The description clearly states that the Tapered Screw-Vent Implant is an "endosseous dental implant." This means it is a device surgically placed within the bone (specifically the maxilla or mandible) to support a dental prosthesis.
- Intended Use: The intended use is for replacing missing teeth and supporting dental loads. This is a therapeutic and restorative function, not a diagnostic one performed on a sample outside the body.
Therefore, this device falls under the category of a medical device (specifically a dental implant), but not an IVD.
N/A
Intended Use / Indications for Use
The Tapered Screw-Vent 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 Implant, 4.1mm 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. In addition, the implant section is tapered with double-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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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. Underneath "zimmer", the word "dental" is written in a smaller, non-bold, sans-serif font.
1900 Aston Avenue Carlsbad, CA 92008 760.929.4300 (ph) 760.431.7811 (fax)
12.8-1
K072589
Special 510(k): Device Modification RE-MARKET NOTIFICATION 510(k)
510(k) SUMMARY (21CFR807.92(a))
-
- Submitter's Information:
2007 007 4
- Submitter's Information:
| Name: | Zimmer Dental Inc. |
|---|---|
| Address: | 1900 Aston Ave. |
| Carlsbad, CA 92008 | |
| Phone: | 760-929-4300 |
| Contact: | William Fisher |
| Date Prepared: | September 13, 2007 |
-
- Device Name: Tapered Screw-Vent Implant, 4.1mm (cat no. TSV4B8, TSV4B10, TSV4B11, TSV4B13, TSV4B16, TSV4H8, TSV4H10, TSV4H11, TSV4H13, TSV4H16)
Device Classification Name: Endosseous Dental Implant
- Device Name: Tapered Screw-Vent Implant, 4.1mm (cat no. TSV4B8, TSV4B10, TSV4B11, TSV4B13, TSV4B16, TSV4H8, TSV4H10, TSV4H11, TSV4H13, TSV4H16)
- Predicate Device(s): Tapered Screw-Vent Implant, 3.7mm (cat. no. TSVB8, TSVB10. TSVB11. TSVB13. TSVB16. TSVH8, TSVH10, TSVH11, TSVH13, TSVH16)
4. Device Description:
The Tapered Screw-Vent Implant, 4.1mm 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. In addition, the implant section is tapered with double-lead threads.
-
- Intended Use:
The Tapered Screw-Vent 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.
- Intended Use:
1
12.8-2
Tapered Screw-Vent Implant, 4.1mm; 510(k) Summary cont'd:
6. Device Comparison:
The new device is equivalent in design with Predicate. The new device is a dimensional modification to the Predicate cleared in K013227, K061410. It differs from the Predicate in that the body portion of the new device is 4.1mmD. The materials, general structure, and function in the endosseous implant system remains the same as the Predicate Device.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular arrangement of the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" surrounding a stylized emblem. The emblem features three parallel lines that curve upwards and to the right, resembling a bird in flight or a stylized representation of human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. William Fisher Regulatory Affairs Associate Zimmer Dental, Incorporated 1900 Aston Avenue Carlsbad, California 92008
OCT 4 * 2007
Re: K072589
Trade/Device Name: Tapered Screw-Vent Implant, 4.1mmD Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: September 13, 2007 Received: September 14, 2007
Dear Mr. Fisher:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2 - Mr. Fisher
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu-Yueh, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K0n2589
12.7
Indications for Use
NO KE 510(k) Number (if known):
Device Name: Tapered Screw-Vent Implant, 4.1mmD
Indications For Use:
The Tapered Screw-Vent 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.
× 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)
Sver Ruaser
Sion Sign-Off) Covision of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K072586