PERMARIDGE SYRINGE

K962838 · Ceramed Corp. · LYC · Aug 20, 1996 · Dental

Device Facts

• Record ID: K962838
• Device Name: PERMARIDGE SYRINGE
• Applicant: Ceramed Corp.
• Product Code: LYC · Dental
• Decision Date: Aug 20, 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; 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.

Indications for Use

Indicated for the delivery of restorative and impression materials in dental or clinical 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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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
[phone]

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.