(100 days)
Tapered SwissPlus®, MTX Surface Implant, Tapered Screw-Vent®, MP-1® HA Coated Implant
Not Found
No
The summary describes a dental implant and its physical characteristics, with no mention of software, algorithms, or any terms related to AI/ML.
Yes
The device is designed for use in the maxilla or mandible to replace missing teeth, indicating a therapeutic purpose in restoring oral function.
No
The device description states it is a dental implant designed for placement in the maxilla or mandible to replace missing teeth, not to diagnose a condition.
No
The device description clearly states it is a physical dental implant made of titanium or titanium alloy, which is a 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 medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description clearly states the Tapered SwissPlus® implant is an endosseous dental implant. This means it is a device surgically placed within the bone.
- Intended Use: The intended use is for replacing missing teeth in the maxilla or mandible. This is a surgical procedure, not a diagnostic test performed on a specimen.
The information provided describes a surgically implanted medical device, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Tapered SwissPlus® 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 SwissPlus® implant is an endosseous dental implant designed for single stage placement. The implant is composed of pure titanium or titanium allov. The implant is tapered with double-lead threads. 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.
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)
Tapered SwissPlus®, MTX Surface Implant, Tapered Screw-Vent®, MP-1® HA Coated Implant
Reference Device(s)
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 a logo for Zimmer Dental. The logo features a stylized letter "Z" inside of a circle. Below the circle, the word "zimmer" is written in a bold, sans-serif font, and the word "dental" is written in a smaller, non-bold font.
Zimmer Dental
1900 Aston Avenue Carlsbad, CA 92008 760.929.4300 (ph) 760.431.7811 (fax)
510k No.: K082639
ge No.: A5-1
DEC 1 9 2008
Traditional 510(k) PRE-MARKET NOTIFICATION
510(k) SUMMARY (21CFR807.92(a))
- Submitter's Information: 1.
| Name: | Zimmer Dental Inc. |
|---|---|
| Address: | 1900 Aston Ave. |
| Carlsbad, CA 92008-7308 | |
| Phone: | 760-929-4300 |
| Contact: | William Fisher |
| Date Prepared: | August 21, 2008 |
-
Device Name: Tapered SwissPlus® Implant 2.
Device Classification Name: Endosseous Dental Implant -
Predicate Device: Tapered SwissPlus®, MTX Surface Implant 3. Tapered Screw-Vent®, MP-1® HA Coated Implant
-
- Device Description:
The Tapered SwissPlus® implant is an endosseous dental implant designed for single stage placement. The implant is composed of pure titanium or titanium allov. The implant is tapered with double-lead threads. 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.
-
- Intended Use:
The Tapered SwissPlus® 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:
-
- Device Comparison:
The new device is substantially equivalent to Tapered SwissPlus MTX Implant, in that it is manufactured to the same implant and interface design. The new device is substantially equivalent to the Tapered Screw-Vent Implant in that it is manufactured of, and coated with the same materials utilizing equivalent processes.
- Device Comparison:
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three bars representing its wings. The eagle is facing to the left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 9 2008
Mr. William Fisher Regulatory Affairs Associate Zimmer Dental Incorporated 1900 Aston Avenue Carlsbad, California 92008-7308
Re: K082639
Trade/Device Name: Tapered SwissPlus® Implant Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: August 29, 2008 Received: September 23, 2008
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.
2
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 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); 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.
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 your 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Susan Kuores
Sachiko S. Liem, Ph.D.
Chiu S. Lin, Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
Tapered SwissPlus® Implant Device Name:
Indications For Use:
The Tapered SwissPlus® 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 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 Purve
(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K020
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