(33 days)
The cement is indicated for use in the cementing (luting) of a implant prosthesis.
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.
This document is a 510(k) summary for a dental cement. It does not contain any information about acceptance criteria or a study proving device performance against such criteria for AI/ML device.
The document states: "Performance Data... Not applicable, 510(k) requests a indication." This indicates that for this particular type of medical device (a dental cement), the submission requirements at the time did not necessitate extensive performance data beyond demonstrating substantial equivalence to a predicate device for its intended use.
Therefore, I cannot provide the requested information.
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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 DriveYorba Linda, CA 92887U.S.A. |
| Contact's Name: | Don KennardRegulatory 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.
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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.
§ 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.