(86 days)
No
The document describes a physical implant made of titanium alloy with specific dimensions and coatings. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
No
Explanation: A therapeutic device is designed to treat or alleviate a medical condition. This device is described as a support for prosthetic devices to restore chewing function, indicating a restorative or assistive purpose rather than a direct therapeutic one.
No
The device is described as an implant to support prosthetic devices for restoring chewing function, not for diagnosing medical conditions.
No
The device description clearly states it is a physical implant fabricated from titanium alloy, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "serve as support for prosthetic devices to restore patient chewing function." This describes a device used in vivo (within the body) for a structural and functional purpose.
- Device Description: The description details a titanium implant designed to be surgically placed. This is consistent with an implantable medical device, not a diagnostic test performed on samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
The intended use for this device is to serve as support for prosthetic devices to restore patient chewing function.
Product codes
DZE
Device Description
How The Device Functions:
Steri-Oss 3.25 mm Replace Implant: This device is designed to serve as support for prosthetic devices to restore patient chewing function.
Scientific Concepts:
Natural dentition is composed of a root (subgingival) and a crown (supragingival). Endosseous dental implant designs in existence are intended to mimic this structure to aid the patient in restoring natural masticatory function. The subject implant is designed to serve as the root of the artificial tooth and the abutment/prosthesis is designed to serve as the crown. The healing screw and healing abutment are intermediary devices which serve to permit satisfactory completion of the implant healing/restoration process.
Device Characteristics:
This implant is 3.25 mm in diameter, 10 to 16 mm in length, and is fabricated from titanium alloy. They are threaded and have a superior external hex. The threaded portion of the implant body has a 50 micron thick plasma sprayed titanium powder coating, and the surface of the external hex is anodized magenta in color.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
To Steri-Oss' Replace Implants and to Steri-Oss' (3.25 mm diameter) Titanium Plasma Sprayed Cylindrical Implant.
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
73433
Original 510(k) Ongmal 016(K)
Steri-Oss 3.25 mm Replace (Titanium Plasma Sprayed) Dental Implant
Section 6
510(k) Summary
Manufacturer Information:
| Submitter's Name: | Steri-Oss Inc. | |
|---|---|---|
| Submitter's Address: | 22895 Eastpark Drive | |
| Yorba Linda, CA 92887 | ||
| USA | ||
| Contact's Name: | Jeff Hausheer, Ph.D. | |
| Contact's Telephone: | 714-282-4800, extension 3815 | |
| Date Prepared: | September 1997 |
Device Name:
| Common Name: | Prosthetic Dental Implant |
|---|---|
| Trade Name: | Steri-Oss 3.25 mm Replace (Titanium Plasma Sprayed) |
| Dental Implant | |
| Classification Name: | Endosseous dental implant |
Predicate Device:
Substantial equivalence is claimed to Steri-Oss' Replace Implants and to Steri-Oss' (3.25 mm diameter) Titanium Plasma Sprayed Cylindrical Implant.
Page 1 of 3
1
Original 510(k) Steri-Oss 3.25 mm Replace (Titanium Plasma Sprayed) Dental Implant
Section &
510(k) Summary
Device Description:
How The Device Functions:
Steri-Oss 3.25 mm Replace Implant: This device is designed to serve as support for prosthetic devices to restore patient chewing function.
Scientific Concepts:
Natural dentition is composed of a root (subgingival) and a crown (supragingival). Endosseous dental implant designs in existence are intended to mimic this structure to aid the patient in restoring natural masticatory function. The subject implant is designed to serve as the root of the artificial tooth and the abutment/prosthesis is designed to serve as the crown. The healing screw and healing abutment are intermediary devices which serve to permit satisfactory completion of the implant healing/restoration process.
Device Characteristics:
This implant is 3.25 mm in diameter, 10 to 16 mm in length, and is fabricated from titanium allov. They are threaded and have a superior external hex. The threaded portion of the implant body has a 50 micron thick plasma sprayed titanium powder coating, and the surface of the external hex is anodized magenta in color.
Page 2 of 3
2
Original 510(k) Steri-Oss 3.25 mm Replace (Titanium Plasma Sprayed) Dental Implant
Section 6
510(k) Summary
Intended Use:
The intended use for this device is to serve as support for prosthetic devices to restore patient chewing functions.
Comparison to Predicate:
The following table provides a comparison of the principle technological characteristics of the 3.25mm Replace (Titanium Plasma Sprayed) Implant and the predicate.
| -----------
(
1
140 Children
| 1 | ||
|---|---|---|
| ------ |
| -
-
.
1 | 1400 1
1 |
| Specification/
Characteristic | Predicate:
Steri-Oss Replace
Implant | New Product:
Steri-Oss 3.25 mm
Replace (Titanium
Plasma Sprayed)
Dental Implant |
|----------------------------------|----------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Material | Titanium | Same |
| Surface
Characteristics | Color-coded hex; TPS
coating on threaded
portion of body | Same |
| Sterility | Sterile | Same |
A second predicate, Steri-Oss' 3.25 mm titanium plasma sprayed cylindrical implant, is presented for the 3.25 mm diameter.
Performance Data:
Not applicable.
Page 3 of 3
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 5 1997
Jeff Hausheer, Ph.D. ·Regulatory Affairs Specialist Steri-Oss, Incorporated 22895 East Park Drive Yorba Linda, California 92687
K973433 Re: Steri-Oss 3.25mm Replace (Titanium Plasma Trade Name: Spray Dental Implant) Requlatory Class: ı il Product Code: DZE September 8, 1997 Dated: September 10, 1997 Received:
Dear Dr. Hausheer:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). 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, qood 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 (Premarket Approval), 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 895. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
4
Page 2 - Dr. Hausheer
through 542 of the Act for devices under the Electronic through 542 of the Act 101 devices ander and in the Federal laws or requlations.
This letter will allow you to begin marketing your device as fills feecer will areas) (k) premarket notification. The FDA described in your stority promote of your device to a legally finding of substancial equivalence of policition for your marketed predicate device rebarts in a camber.
device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in regulacion (21 cm rares), please contact the Office of ville diagnoscic devices) / proams of the questions on Compilance at (3017 334 4010. India device, please contact che promocion and adversibling of (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
the regulation entitled, "Misbranding by reference to premation on your responsibilities under the Act may be Information on your responsible of Small Manufacturers Assistance obtained Trom the Division of 638-2041 or (301) 443-6597 or at at its coll-free namber (05) -300f-2007 -050f-110smamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timot A Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Original 510(k) Original 510(K)
Steri-Oss 3.25 mm Replace (Titanium Plasma Sprayed) Dental Implant
Section 9
Indications for Use
Page 1 of 1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
3.25 mm Replace (Titanium Plasma Sprayed) Dental Implant Device Name:
Indications For Use: The intended use for this device is to serve as support for prosthetic devices to restore patient chewing function.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K233433 |
| Prescription Use | ✓ OR Over-The-Counter Use _______ (Per 21 CFR 801.109) |
(Optional Format 1-2-96)