(109 days)
The Tapered Screw-Vent®, Screw-Vent®, AdVent®, and Zimmer® One-Piece 3.7 mm Dental 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.
Zimmer One-Piece 3.7 mm implants are limited to restorations (immediately loaded or loaded after a conventional healing period) in the premolar, cuspid, and incisor regions of partially edentulous jaws.
The purpose of this submission is to add an immediate loading single tooth indication to the following implants systems previously cleared by FDA: Tapered Screw-Vent, Screw-Vent (K013227), AdVent (K011245) and Zimmer One-Piece 3.7 mm (K052997). These implants are titanium alloy, self-tapping implants that incorporate either the MTX or MP-1 surface. There is no significant difference in design or materials between the implants in this submission and the previously cleared implants from Zimmer Dental.
The provided document describes the 510(k) premarket notification for the Zimmer Dental Implants - Immediate Loading Indication. It is primarily a declaration of substantial equivalence to previously cleared devices, rather than a detailed study demonstrating performance against specific acceptance criteria for a novel device.
Therefore, many of the requested sections about acceptance criteria, study details, sample sizes, expert involvement, and ground truth cannot be fully extracted from this document, as it focuses on demonstrating equivalence rather than a de novo performance study.
Here's what can be inferred and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. The basis for clearance is substantial equivalence to predicate devices. The "performance" reported is that the "Zimmer Dental Implants - Immediate Loading Indication have the following similarities to the predicate devices":
- Same intended use
- Same operating principle
- Same basic design
- Same materials
- Packaged and sterilized using the same materials and processes.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) for substantial equivalence based on product design and material similarities to previously cleared devices, not a performance study with a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. There is no mention of a test set requiring expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no mention of a test set or adjudication process.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/software device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (dental implants), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices based on their design, materials, and intended use.
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not a learning algorithm or a study requiring data collection for training.
9. How the ground truth for the training set was established
Not applicable. See point 8.
Summary based on the provided document:
The Zimmer Dental Implants - Immediate Loading Indication received 510(k) clearance by demonstrating substantial equivalence to legally marketed predicate devices (Tapered Screw-Vent, Screw-Vent, AdVent, and Zimmer One-Piece 3.7 mm Implants, and Nobel Biocare TiUnite Dental Implants).
The "acceptance criteria" and "performance" described are qualitative similarities in:
- Intended use
- Operating principle
- Basic design
- Materials
- Packaging and sterilization methods
No specific clinical studies with defined quantitative acceptance criteria, test sets, or expert evaluations are detailed in this 510(k) summary for the immediate loading indication, as the submission relies on the established safety and effectiveness of the predicate devices.
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510(k) Premarket Notification
KOGIY 10
510(k) Summary
ADMINISTRATIVE INFORMATION
| Manufacturer Name: | Zimmer Dental, Inc.1900 Aston Ave.Carlsbad, CA 92008Telephone (760) 929-4300FAX (760) 431-7811 | SEP - 8 2006 |
|---|---|---|
| Official Contact: | Kerry Foote | |
| Representative/Consultant: | Floyd G. LarsonPaxMed International, LLC11234 El Camino Real, Suite 200San Diego, CA 92130Telephone (858) 792-1235FAX (858) 792-1236 | |
| DEVICE NAME: |
| Classification Names: | Implant, Endosseous, Root-Form |
|---|---|
| Trade/Proprietary Name: | Zimmer Dental Implants - Immediate LoadingIndication |
| Common Name: | Dental Implant |
ESTABLISHMENT REGISTRATION NUMBER
The Establishment Registration number for Zimmer Dental is 2023141. The owner/operator number is 1822565.
DEVICE CLASSIFICATION
FDA has classified "Implant, Endosseous, Root-Form" as a Class II device (21 CFR 872.3640). This device classification is reviewed by the Dental Devices Branch. The product code is DZE.
INDICATIONS FOR USE
The Tapered Screw-Vent®, Screw-Vent®, AdVent®, and Zimmer® One-Piece 3.7 mm Dental 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
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more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
Zimmer One-Piece 3.7 mm implants are limited to restorations (immediately loaded or loaded after a conventional healing period) in the premolar, cuspid, and incisor regions of partially edentulous jaws.
DEVICE DESCRIPTION
The purpose of this submission is to add an immediate loading single tooth indication to the following implants systems previously cleared by FDA: Tapered Screw-Vent, Screw-Vent (K013227), AdVent (K011245) and Zimmer One-Piece 3.7 mm (K052997). These implants are titanium alloy, self-tapping implants that incorporate either the MTX or MP-1 surface. There is no significant difference in design or materials between the implants in this submission and the previously cleared implants from Zimmer Dental.
EQUIVALENCE TO MARKETED DEVICE
Zimmer Dental has submitted information to demonstrate that, for the purposes of FDA's regulation of medical devices, Zimmer Dental Implants - Immediate Loading Indication are substantially equivalent in indications and design principles to predicate devices previously cleared for marketing by FDA: Zimmer Dental Tapered Screw-Vent Implants and Screw-Vent Implants (K013227, K950577), Zimmer Dental AdVent Implants (K011245, K002614), Zimmer One-Piece 3.7 mm Implant (K052997); and the Nobel Biocare TiUnite Dental Implants (K050705).
Zimmer Dental Implants - Immediate Loading Indication have the following similarities to the predicate devices:
- · have the same intended use (Nobel Biocare Predicate),
- · use the same operating principle,
- · incorporate the same basic design
- · incorporate the same materials, and
- · are packaged and sterilized using the same materials and processes.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 8 2006
Zimmer Dental, Incorporated C/O Mr. Floyd G. Larson PaxMed International, LLC 11234 EL Camino Real, Suite 200 San Diego, California 92130
Re: K061410
Trade/Device Name: Zimmer Dental Implant System Regulation Number: 872.3640 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: DZE Dated: August 29, 2006 Received: August 31, 2006
Dear Mr. Larson:
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.
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Page 2 - Mr. Larson
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 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,
Chris Liu, 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
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Indications for Use
510(k) Number (if known):_____K061410
Device Name: Zimmer Dental Implant System
Indications For Use:
The Tapered Screw-Vent®, AdVent®, AdVent®, and Zimmer® One-Piece 3.7 mm Dental 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.
Zimmer One-Piece 3.7 mm implants are limited to restorations (immediately loaded or loaded after a conventional healing period) in the premolar, cuspid, and incisor regions of partially edentulous jaws.
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)
Susan Quinn
inn Sian-Off) with of Anesthestology, General Hosp i . . . . . . . Dental I Carry Number .
Page 1 of
§ 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.