Who is the manufacturer of STERI-OSS TEMPORARY IMPLANT CEMENT?

Steri-Oss, Inc. filed the 510(k) submission for STERI-OSS TEMPORARY IMPLANT CEMENT (K963078).

What is the FDA product code for STERI-OSS TEMPORARY IMPLANT CEMENT?

EMA. It is classified under 21 CFR 872.3275 as a Class 2 device in the Dental panel.

What is the regulatory pathway for STERI-OSS TEMPORARY IMPLANT CEMENT?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like STERI-OSS TEMPORARY IMPLANT CEMENT?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

STERI-OSS TEMPORARY IMPLANT CEMENT

K963078 · Steri-Oss, Inc. · EMA · Sep 10, 1996 · Dental

Device Facts

Record ID	K963078
Device Name	STERI-OSS TEMPORARY IMPLANT CEMENT
Applicant	Steri-Oss, Inc.
Product Code	EMA · Dental
Decision Date	Sep 10, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3275
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The cement is indicated for use in the cementing (luting) of a implant prosthesis.

Device Story

Steri-Oss Temporary Implant Cement; two-part polyalkylene resin paste; self-curing upon mixing; used by dentists for retention of implant prostheses; provides temporary fixation.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Two-part polyalkylene resin paste; self-curing; dental cement.

Indications for Use

Indicated for cementing (luting) of implant prostheses in dental patients.

Regulatory Classification

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. 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.

Predicate Devices

Septodont’s Resiment resin cement

Related Devices

K972965 — STERI-OSS UNTIL IMPLANT CEMENT · Steri-Oss, Inc. · Nov 7, 1997
K982400 — STERI-OSS' IMPROV TEMPORARY DENTAL CEMENT · Steri-Oss, Inc. · Sep 23, 1998
K134021 — ESTEMP IMPLANT, ESTEMP CLEAR · Spident Co., Ltd. · Jun 10, 2014
K142446 — Fixtemp Cement · Exacta Dental Direct, Inc. · Jun 4, 2015
K040895 — INTEGRITY TEMPORARY CEMENT · Dentsply Intl. · May 21, 2004

Submission Summary (Full Text)

{0} SEP 10 1996 K963078 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 Trade Name: Steri-Oss Temporary Implant Cement 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. 14 {1} 15 # 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.