HYBRID RESIN COMPOSITE

K964867 · Parkell, Inc. · KLE · Apr 11, 1997 · Dental

Device Facts

• Record ID: K964867
• Device Name: HYBRID RESIN COMPOSITE
• Applicant: Parkell, Inc.
• Product Code: KLE · Dental
• Decision Date: Apr 11, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

May be described as a radiopaque, light-cured, hybrid composite resin for use as a tooth colored dental restorative in Class I, II, III, IV and V cavities. It is contoured and polished using currently available finishing diamonds, finishing burs, discs, and polishing pastes. When used as indicated, the material is recommended for restoring proper form and function of restored teeth.

Device Story

Radiopaque, light-cured, hybrid composite resin; used as tooth-colored dental restorative for Class I-V cavities. Applied by dental professionals; contoured/polished using standard dental burs, diamonds, discs, and pastes. Polymerized via standard visible light curing devices. Restores tooth form and function.

Clinical Evidence

Bench testing only.

Technological Characteristics

Radiopaque, light-cured hybrid composite resin. Polymerizable via visible light curing units. Formulated with standard dental resin components.

Indications for Use

Indicated for restoration of Class I, II, III, IV, and V dental cavities. Contraindicated in patients with known acrylate allergies or hypersensitivities.

Regulatory Classification

Identification

A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.

Predicate Devices

• PRISMA-FIL
• ESTILUX POSTERIOR XR
• BISFIL-1
• OCCLUSIN
• HERCULITE
• P-50
• PERTAC HYBRID
• Z100
• TETRIC

Submission Summary (Full Text)

{0}

K964867
parkell

# APR 11 1997

## 510(k) SUMMARY

**Submitter:**
Nelson J. Gendusa, DDS
Director of Research
Parkell Products, Inc.
155 Schmitt Blvd.
Farmingdale, NY 11735
TEL: [phone]
FAX: [phone]

**Contact:**
Same as above.

**Date of Submission:**
November 25, 1996

**Trade Name:**
Hybrid Composite Resin

**Common Name:**
Hybrid Composite Material

**Classification Name:**
Tooth Shade Resin Material (21 CFR §872.3690)

**Equivalence:**
PRISMA-FIL; ESTILUX POSTERIOR XR; BISFIL-1; OCCLUSIN; HERCULITE; P-50; PERTAC HYBRID; Z100; TETRIC

**Description and Intended Use:**
May be described as a radiopaque, light-cured, hybrid composite resin for use as a tooth colored dental restorative in Class I, II, III, IV and V cavities. It is contoured and polished using currently available finishing diamonds, finishing burs, discs, and polishing pastes. When used as indicated, the material is recommended for restoring proper form and function of restored teeth.

The above-cited material contains materials that are common in dental resins and pose no health hazard when used according to directions. Use of composite resins may be contra-indicated in persons with known acrylate allergies and/or hypersensitivities. The material is polymerizable with currently available visible light curing devices.

155 Schmitt Blvd. • P.O. Box 376 • Farmingdale, New York 11735 U.S.A.
Phone: [phone] • Fax: [phone]