(95 days)
Not Found
No
The 510(k) summary describes a physical dental implant and its intended use, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is described as "intended to be placed in the upper or lower jaw to support prosthetic devices such as artificial teeth, and to restore a patient's chewing function," which clearly indicates a therapeutic purpose.
No
The device is described as a dental implant intended to support prosthetic devices and restore chewing function, not to diagnose medical conditions.
No
The device description clearly indicates a physical, threaded dental implant made of titanium, which is a hardware component.
No, 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. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text clearly describes a dental implant that is surgically placed directly into the jawbone to support prosthetic teeth and restore chewing function. It is a physical implant, not a device that analyzes biological samples.
The description focuses on the physical characteristics of the implant, its surgical placement, and its function within the body. This aligns with the definition of a medical device but not specifically an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Nobel Biocare's Modified Surface Implant is intended to be placed in the upper or lower iaw to support prosthetic devices such as artificial teeth, and to restore a patient's chewing function. This may be accomplished using either a two stage surgical procedure or a single stage surgical procedure.
If the single stage procedure is used, these implants may be loaded immediately following insertion - PROVIDED - at least four implants are placed, and are splinted with a bar. These implants must be placed predominantly in the anterior mandible (between the mental foramina) where good initial stability of the implants, with or without bi-cortical anchorage, can most often be obtained.
Product codes
DZE
Device Description
Nobel Biocare's Modified Surface Implant is a threaded, hex-lock root-form dental implant. It is 3.75-mm in diameter and is available in lengths ranging from 7-mm to 20mm. The surface of the threaded portion of the implant has a titanium oxide layer that is uniformly thin (mean
§ 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
Section 8 510(k) Summary
Nobel Biocare USA Letterhead
510(k) Summary
A. Manufacturer Information:
| Submitter's Name: | Nobel Biocare USA, Inc. |
|---|---|
| Submitter's Address (U.S. Representative/Distributor): | 22825 Eastpark Drive |
| Yorba Linda, CA 92887 USA | |
| Contact's Name: | Jeff Hausheer, Ph.D., Regulatory Affairs Specialist |
| Contact's Telephone No.: | 714-282-4800, extension 7832 |
| Date Prepared: | October 1999 |
| Address (Manufacturer): | Nobelpharma Production AB |
| Dimbovagen 2 | |
| Karlskoga S-691-51 | |
| SWEDEN | |
| Manufacturer's Registration No. | 9611993 |
B. Device Name:
- Common Name: Dental Implant Trade Name: Nobel Biocare's Modified Surface Implant
C. Classification:
Classification Name: Endosseous Dental Implant Classification Number: DZE Classification Citation: 21 CFR 872.3640
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Nobel Biocare USA - October 1999
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Section 8 510(k) Summary (continued)
D. Device Description:
Nobel Biocare's Modified Surface Implant is a threaded, hex-lock root-form dental implant. It is 3.75-mm in diameter and is available in lengths ranging from 7-mm to 20mm. The surface of the threaded portion of the implant has a titanium oxide layer that is uniformly thin (mean✓ | OR | Over-The-Counter Use |
| (Per 21 CFR 801.109) | | (Optional Format 1-2-96) |
|
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
K993595
510(k) Number | NOBEL BIOCARE USA - | CTOBER 1999 |