← Product Code [LYC](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LYC) · K962838

# PERMARIDGE SYRINGE (K962838)

_Ceramed Corp. · LYC · Aug 20, 1996 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LYC/K962838

## Device Facts

- **Applicant:** Ceramed Corp.
- **Product Code:** [LYC](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LYC.md)
- **Decision Date:** Aug 20, 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; consists of plastic barrel, polypropylene plunger, and rubber tip; operated by clinician to dispense material into target site; facilitates precise application of dental materials.

## Clinical Evidence

Bench testing only.

## Technological Characteristics

Manual syringe; materials: cellulose acetate propionate barrel, polypropylene plunger, rubber plunger tip; non-powered; standalone device.

## 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)

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K962838

AUG 20 1996

# 510(k) SUMMARY

July 20, 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:**
PermaRidge syringe
Classification Name: Syringe for Restorative and Impression Material

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

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

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

6.  **Comparison of Product Characteristics:**
The PermaRidge syringe consists of a plastic (cellulose acetate propionate) barrel, polypropylene plunger, and rubber plunger tip.

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LYC/K962838](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LYC/K962838)

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