OSTEOGRAF STAINLESS STEEL SYRING

K962786 · Ceramed Corp. · LYC · Aug 1, 1996 · Dental

Device Facts

• Record ID: K962786
• Device Name: OSTEOGRAF STAINLESS STEEL SYRING
• Applicant: Ceramed Corp.
• Product Code: LYC · Dental
• Decision Date: Aug 1, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2

Intended Use

Delivery of restorative and impression material.

Device Story

Manual delivery device for restorative and impression materials; stainless steel barrel, polypropylene plunger, rubber plunger tip; operated by dental professionals; facilitates precise application of dental materials into oral cavity; replaces glass syringe counterparts; provides durable, reusable delivery mechanism.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: stainless steel barrel, polypropylene plunger, rubber plunger tip. Manual operation; reusable; non-powered.

Indications for Use

Indicated for the delivery of restorative and impression materials in clinical dental settings.

Regulatory Classification

Identification

Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.

Special Controls

*Classification.* (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• OsteoGraf glass syringe
• Bio-Interfaces syringe

Submission Summary (Full Text)

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K962786

AUG - I 1996 510(k) SUMMARY

July 15, 1996

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

1. **Submitter:**
CeraMed Corporation
12860 West Cedar Drive
Lakewood, CO 80228
[phone]

2. **Device Name:**
OsteoGraf stainless steel syringe
Classification Name: Syringe for Restorative and Impression Material

3. **Predicate Device:**
OsteoGraf glass syringe
Bio-Interfaces syringe

4. **Device Description:**
The OsteoGraf stainless steel syringe is a device used for the delivery of restorative and impression material. It is composed of a stainless steel barrel, polypropylene plunger, and rubber plunger tip.

5. **Intended Use:**
Delivery of restorative and impression material.

6. **Comparison of Product Characteristics:**
The OsteoGraf stainless steel syringe consists of a stainless steel barrel, polypropylene plunger, and rubber plunger tip.