PERTAC II/PERTAC II APLITIP

K962440 · Espe GmbH & Co. Kg. · EBF · Sep 11, 1996 · Dental

Device Facts

• Record ID: K962440
• Device Name: PERTAC II/PERTAC II APLITIP
• Applicant: Espe GmbH & Co. Kg.
• Product Code: EBF · Dental
• Decision Date: Sep 11, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The modified materials, referred to by the tradenames Pertac® II and Pertac® II Aplitip®, are intended as composite filling materials, and are indicated for the following uses: (1) fillings in Class I, III, IV, V and small Class II cavities; (2) fillings in deciduous teeth; (3) eroded and abraded cervical areas (wedge-shaped defects); (4) fabricating indirect anterior laminate veneers and tooth colored inlays; and (5) repairing facings on crowns and bridges.

Device Story

Pertac® II and Pertac® II Aplitip® are light-cured composite filling materials; used by dentists for restorative dental procedures; applied to tooth cavities or surfaces to restore structure or aesthetics; material hardens to provide durable filling; clinical benefit includes restoration of tooth function and appearance.

Clinical Evidence

Bench testing only. Safety confirmed via biocompatibility studies including skin irritation, eye irritation, Ames test, and acute toxicity. Compliance with DIN and ISO standards for dental composite materials demonstrated.

Technological Characteristics

Dental composite resin material. Meets relevant DIN and ISO standards for dental composites. Supplied as Pertac® II and Pertac® II Aplitip® delivery systems.

Indications for Use

Indicated for patients requiring dental restorations including Class I, III, IV, V, and small Class II cavities; deciduous teeth; cervical wedge-shaped defects; fabrication of indirect anterior laminate veneers and tooth-colored inlays; and repair of crown/bridge facings.

Regulatory Classification

Identification

Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.

Predicate Devices

• Pertac®-Hybrid® (K900510)

Submission Summary (Full Text)

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K962440
SEP 11 1996

## II. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

ESPE is submitting a 510(k) premarket notification for modifications to its 510(k) submission for tooth shade resin material, tradenamed Pertac®-Hybrid® (K900510). The modified materials, referred to by the tradenames Pertac® II and Pertac® II Aplitip®, are intended as composite filling materials, and are indicated for the following uses: (1) fillings in Class I, III, IV, V and small Class II cavities; (2) fillings in deciduous teeth; (3) eroded and abraded cervical areas (wedge-shaped defects); (4) fabricating indirect anterior laminate veneers and tooth colored inlays; and (5) repairing facings on crowns and bridges.

ESPE is claiming substantial equivalence to its previously cleared Pertac®-Hybrid® product. These products have almost identical intended uses and similar ingredient compositions. To support substantial equivalence to predicate products, the physical and technical characteristics of Pertac® II/Pertac® II Aplitip® have been compared to those of Pertac®-Hybrid®. In addition, certain tests have been performed by the manufacturer, Peroxid-Chemie, on the peroxide component added to Pertac®

WAB1A/A48034.1

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II/Pertac® II Aplitip® to confirm safe use of the product, including skin irritation, eye irritation, Ames and acute toxicity.

Pertac® II and Pertac® II Aplitip® meet the requirements of relevant DIN and ISO standards for dental composite material.

ESPE's 510(k) has been submitted on June 19, 1996, by Dr. Barbara Wagner at Am Griesberg 2, D-82229 Seefeld, Germany (011-49-8152-700395).

WADIA/A48034.1