(90 days)
Not Found
No
The 510(k) summary describes a physical dental implant and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a dental implant intended to restore patient chewing function, which is a therapeutic purpose.
No
The device description indicates that the implants are designed to restore chewing function by supporting prosthetic devices, not to diagnose a condition.
No
The device description clearly describes a physical dental implant made of titanium alloy or hydroxyapatite, with specific dimensions and configurations, intended for surgical placement in the jaw bone. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that the Steri-Oss Single Stage Surgical Placement implants are surgically placed into the jaw bone to support prosthetic devices for restoring chewing function. This is a physical implant, not a test performed on a biological sample.
- Intended Use: The intended use is to serve as support for prosthetic devices to restore patient chewing function, which is a mechanical and functional purpose, not a diagnostic one.
Therefore, this device falls under the category of a surgical implant or prosthetic device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
Steri-Oss Single Stage Surgical Placement implants are intended to serve as support for prosthetic devices to restore patient chewing function and are surgically placed using the single stage surgical placement method.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
Steri-Oss Single Stage Surgical Placement dental implants are designed to serve as supports for prosthetic devices intended to restore a patient's chewing function. Natural teeth are anatomically composed of a root - the subgingival portion of the tooth - and a crown - that part of the tooth above the gum. Dental implants are intended to mimic the root portion of this structure to aid in restoration of chewing function in patients who have lost natural dentition through disease, trauma or other cause. Implants integrate into the jaw bone. By providing a stable foundation analogous to the root portion of a natural tooth, and in combination with an abutment structure (i.e., a foundation for an artificial crown), dental implants provide a platform upon which the dentist can build an artificial crown or bridge, thereby restoring the patient's ability to chew. The Steri-Oss Single Stage Surgical Placement implants are slightly tapered and vary in diameter from 3.25 millimeters to 5.0 millimeters (neck dimension) depending upon the specific implant design, and vary from 8 millimeters to 18 millimeters in length. They may have no coating or a coating consisting of titanium alloy or hydroxyapatite. Titanium or hydroxyapatite coatings are applied as a plasma spray. The implants are available in cylindrical or threaded configurations and have either a flat top or a hex lock configuration at the apical surface.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
jaw bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentist
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): 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
Steri-Oss Implants For Single Stage Placement 510(k)/SSP
NOV 1 4 1996
Letterhead
510(k) Summary
SECTION 7: 510(k) SUMMARY
Manufacturer Information:
| Submitter's Name: | Steri-Oss Inc. |
|---|---|
| Address: | 22895 Eastpark Drive |
| Yorba Linda CA 92887, U.S.A. | |
| Contact's Name: | Jeff Hausheer, Ph.D. |
| Regulatory Affairs | |
| Telephone Number: | 714-282-4800, extension 3815 |
| Date Prepared: | August 1996 |
Device Names:
| Common Name: | Endosseous Dental Implant for Single Stage Surgical
Placement |
|----------------------|------------------------------------------------------------------|
| Trade Names: | See appended list (page 4) |
| Classification Name: | Endosseous Implant (all designs) |
Predicate Device:
Substantial equivalence is claimed to
Steri-Oss' Oss' "Titanium Alloy Screw Series Implant For Single Stage Surgical Placement ("SSP")". an uncoated 3.8-mm diameter threaded titanium alloy implant (510(k) number K944158, Steri-Oss catalog numbers 2208, 2210, 2212, 2214, 2216, and 2218).
Device Description:
- How The Device Functions:
Steri-Oss Single Stage Surgical Placement dental implants are designed to serve as supports for prosthetic devices intended to restore a patient's chewing function.
Page 1 of 4
1
SECTION 7: 510(k) SUMMARY (continued)
Device Description (continued):
2) Scientific Principles:
Natural teeth are anatomically composed of a root - the subgingival portion of the tooth - and a crown - that part of the tooth above the gum. Dental implants are intended to mimic the root portion of this structure to aid in restoration of chewing function in patients who have lost natural dentition through disease, trauma or other cause. Implants integrate into the jaw bone. By providing a stable foundation analogous to the root portion of a natural tooth, and in combination with an abutment structure (i.e., a foundation for an artificial crown), dental implants provide a platform upon which the dentist can build an artificial crown or bridge, thereby restoring the patient's ability to chew.
3) Physical Characteristics
The Steri-Oss Single Stage Surgical Placement implants are slightly tapered and vary in diameter from 3.25 millimeters to 5.0 millimeters (neck dimension) depending upon the specific implant design, and vary from 8 millimeters to 18 millimeters in length. They may have no coating or a coating consisting of titanium alloy or hydroxyapatite. Titanium or hydroxyapatite coatings are applied as a plasma spray. The implants are available in cylindrical or threaded configurations and have either a flat top or a hex lock configuration at the apical surface.
Intended Use:
Steri-Oss Single Stage Surgical Placement implants are intended to serve as support for prosthetic devices to restore patient chewing function and are surgically placed using the single stage surgical placement method.
Comparison to the Predicate Device(s):
Steri-Oss implants indicated for single stage surgical placement are identical in all aspects to corresponding implants cleared for marketing for placement using the two stage surgical placement method. including the materials from which they are fabricated, the fabrication methods, the physical dimensions and geometry, the method of sterilization. the type of packaging, and all other respects.
2
SECTION 7: 510(k) SUMMARY (continued)
The following table provides a comparison of the technological characteristics of the Steri-Oss implant and the predicate device
Product Comparison
| Characteristic | Predicate Device | Submission Device |
|---|---|---|
| Body Material | Titanium alloy | Same |
| Coating Materials | None, or | |
| HA or | ||
| TPS | ||
| (depending upon configuration) | Same | |
| Design | Threaded or cylindrical | Same |
| Superior surface | Flat or Hex Lock | Same |
| Length (mm) | 8, 10, 12, 14, 16, 18 mm | Same |
| Diameter (mm) | 3.25, 3.8, 4.1/4.5, 5.0/4.5 mm | Same |
| Packaging | Double vial | Same |
| Sterility | Sterile | Same |
Page 3 of 4
3
SECTION 7: 510(k) SUMMARY (continued)
Trade Names:
-
- Flat-top, threaded, HA-coated, 3.8-mm diameter SSP
- Flat-top, cylinder, HA-coated, 3.25-mm diameter SSP 2)
- Flat-top, cylinder, HA-coated, 3.8-mm diameter SSP 3)
- Flat-top, cylinder, TPS-coated, 3.25-mm diameter SSP 4)
- Flat-top, cylinder, TPS-coated, 3.8-mm diameter SSP 5)
- Hex-lock, threaded, uncoated, 3.25-mm diameter SSP ର)
-
- Hex-lock, threaded, uncoated, 3.8-mm diameter SSP
-
- Hex-lock, threaded, uncoated, 4.1-mm neck / 4.5-mm body diameter SSP
-
- Hex-lock, threaded, uncoated, 5.0-mm neck / 4.5-mm body diameter SSP
-
- Hex-lock, threaded, HA-coated, 3.25-mm diameter SSP
-
- Hex-lock, threaded, HA-coated, 3.8-mm diameter SSP
-
- Hex-lock, threaded, HA-coated, 4.1-mm neck / 4.5-mm body diameter SSP
-
- Hex-lock, threaded, HA-coated, 5.0-mm neck / 4.5-mm body diameter SSP
-
- Hex-lock, threaded. TPS coated, 3.25-mm diameter SSP
-
- Hex-lock, threaded, TPS coated, 3.8-mm diameter SSP
-
- Hex-lock, threaded, TPS coated, 5.0-mm neck/4.5-mm body diameter SSP
-
- Hex-lock, cylinder, HA-coated, 3.25-mm diameter SSP
-
- Hex-lock, cylinder, HA-coated, 3.8-mm diameter SSP
-
- Hex-lock, cylinder, TPS coated, 3.25-mm diameter SSP
-
- Hex-lock, cylinder, TPS coated, 3.8-mm diameter SSP