← Product Code [LYC](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LYC) · K962786

# OSTEOGRAF STAINLESS STEEL SYRING (K962786)

_Ceramed Corp. · LYC · Aug 1, 1996 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LYC/K962786

## Device Facts

- **Applicant:** Ceramed Corp.
- **Product Code:** [LYC](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LYC.md)
- **Decision Date:** Aug 1, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3930
- **Device Class:** Class 2
- **Review Panel:** Dental

## Indications for 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.

## Regulatory 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)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

{0}

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
(303) 985-0800

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.

---

**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LYC/K962786](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LYC/K962786)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com