(33 days)
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Not Found
No
The summary describes a physical cement material and its intended use, with no mention of software, algorithms, or any technology related to AI or ML.
No.
The device is a cement used for retaining an implant prosthesis, which is a structural component rather than a device designed to prevent, treat, or mitigate a disease or condition.
No
The device is a cement used for retaining implant prostheses, not for diagnosing conditions or diseases.
No
The device description clearly states it is a "two part paste" and "polyalkylene material," indicating it is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "cementing (luting) of a implant prosthesis." This is a mechanical function within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a "cement for retention of implant prosthesis." It's a material used to hold a medical device in place.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information about a patient's health condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The cement is indicated for use in the cementing (luting) of a implant prosthesis.
Product codes
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Device Description
How the device functions: The Steri-Oss Temporary Implant Cement serves as a cement for retention of implant prosthesis. The cement is a two part paste which is self cured on mixing and application. The product is provided in two 10 gram containers of polyalkylene material.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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, 510(k) requests a indication.
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.
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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).
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§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.
0
SEP 1 0 1996
Steri-Oss Temporary Implant Cement Orginal 510(k) Submission
Section 6
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: | Don Kennard |
| Regulatory Affairs | |
| Phone: | 714-282-4811 |
| Fax: | 714-988-9236 |
| Date Prepared: | August 1996 |
Devices Names:
Common Name: Dental Cement
Steri-Oss Temporary Implant Cement Trade Name:
Classification Name: Dental Cement
Predicate Device:
Substantial equivalence is claimed to Septodont's Resiment resin cement. 、・・・
Device Description:
How the device functions: The Steri-Oss Temporary Implant Cement serves as a cement for retention of implant prosthesis. The cement is a two part paste which is self cured on mixing and application. The product is provided in two 10 gram containers of polyalkylene material.
1
Steri-Oss Temporary Implant Cement Orginal 510(k) Submission
Intended Use:
The cement is indicated for use in the cementing (luting) of a implant prosthesis.
Comparison to Predicate
The following table provides a comparison of the technological characteristic of the Steri-Oss Temporary Implant Cement to the predicate.
| Item | Predicate | Steri-Oss |
|---|---|---|
| Curing | Self Cured | Self Cured |
| System | Two part system | Two part system |
| Cement base | Resin filled | Resin filled |
Performance Data
..
Not applicable, 510(k) requests a indication.