(86 days)
Not Found
No
The description focuses on the physical characteristics and materials of a dental implant, with no mention of AI or ML capabilities.
Yes.
The device is described as an implant that serves as support for prosthetic devices to restore patient chewing function, which is a therapeutic purpose.
No
Explanation: The device is described as an implant used for supporting prosthetic devices to restore chewing function, indicating a therapeutic or supportive role rather than a diagnostic one. No mention of diagnosis or disease detection is found in the text.
No
The device description explicitly states it is an 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 physical implant made of titanium alloy, designed to be surgically placed. This is consistent with a medical device used for treatment or restoration, not for testing samples in vitro.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
Therefore, this device is a medical device intended for surgical implantation, not an In Vitro Diagnostic device.
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 functions.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
This device is designed to serve as support for prosthetic devices to restore patient chewing function. 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. 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 hydroxyapatite 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
. . . . . . .
Original 510(k) Original 510(K)
Steri-Oss 3.25 mm Replace (Hydroxyapatite-Coated) 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 (Hydroxyapatite-Coated) |
| Dental Implant | |
| Classification Name: | Endosseous dental implant |
Predicate Device:
Substantial equivalence is claimed to Steri-Oss' (Hydroxyapatite-coated) Replace Substantial equivalence 13 Claimod To Stort Oct (1) ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Implant (K911592).
Page 1 of 3
1
Original 510(k) Steri-Oss 3.25 mm Replace (Hydroxyapatite-Coated) Dental Implant
Section 6 510(k) Summary
Device Description:
How The Device Functions:
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 hydroxyapatite coating, and the surface of the external hex is anodized magenta in color.
Page 2 of 3
Steri-Oss Inc. - September 1997
2
Original 510(k) Steri-Oss 3.25 mm Replace (Hydroxyapatite-Coated) 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 (Hydroxyapatite-Coated) Implant and the predicate.
Comparison to Predicates:
| Specification/
Characteristic | Predicate:
Steri-Oss Replace Implant | New Product:
Steri-Oss 3.25 mm Replace
(Hydroxyapatite-Coated) Dental Implant |
|----------------------------------|---------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| Material | Titanium | Same |
| Surface
Characteristics | Color-coded hex;
hydroxyapatite 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
Steri-Oss Inc. - September 1997
3
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "HUMAN SERVICES - USA" and "DEPARTMENT OF HEALTH" are arranged in a circular pattern around the caduceus. The logo is black and white.
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 92687 Yorba Linda, California
K973423 Re : Steri-Oss 3.25mm Replace (Hydroxyapatite-Trade Name: Coated) Dental Implant Requlatory Class: III 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, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਰ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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 Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
K. Allstot
A. Ulatowsk: Timo 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) Onginal 310(K)
Steri-Oss 3.25 mm Replace (Hydroxyapatite-Coated) Dental Implant
Section 9
Indications for Use
Page 1 of _1
:
:
.
1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
3.25 mm Replace (Hydroxyapatite-Coated) 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)
| Sund Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off)Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K973423 |
Prescription Use
✓ OR Over-The-Counter Use ____ (Per 21 CFR 801.109)
(Optional Format 1-2-96)
Steri-Oss Inc. - September 1997
30
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