DIMENSION PENTA/DIMENSION GARANT L/POLYVINYL SILOXANE ADHESIVE

K960547 · Espe GmbH & Co. Kg. · ELW · Mar 15, 1996 · Dental

Device Facts

• Record ID: K960547
• Device Name: DIMENSION PENTA/DIMENSION GARANT L/POLYVINYL SILOXANE ADHESIVE
• Applicant: Espe GmbH & Co. Kg.
• Product Code: ELW · Dental
• Decision Date: Mar 15, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Intended Use

Dimension® Penta and Dimension® Garant L are both polyvinyl siloxane impression material, composed of a base paste and catalyst, used to make impressions of inlay, onlay, crown and bridge preparations, and edentulous jaws. Polyvinyl Siloxane Adhesive is intended to assure adhesion of impression material to the impression tray and to avoid deformation during impression taking.

Device Story

Polyvinyl siloxane impression materials (Dimension Penta, Dimension Garant L) and adhesive; used for dental impressions (inlays, onlays, crowns, bridges, edentulous jaws). Dimension Penta utilizes free-standing electronic mixing apparatus (Pentamix); Dimension Garant L utilizes hand-held automatic mixing/dispensing apparatus (Garant Dispenser). Adhesive ensures material-to-tray bonding; prevents deformation. Used in dental clinics by practitioners. Benefits include improved viscosity, mixability, stability, and user convenience compared to previous formulations.

Clinical Evidence

Bench testing only. Performance characteristics compared to predicate devices. Compliance with DIN, ISO, and ADA standards for impression materials demonstrated.

Technological Characteristics

Polyvinyl siloxane impression material (base paste and catalyst). Modified viscosity and mixability for automatic mixing apparatus (Pentamix or Garant Dispenser). Includes pigments and stability-enhancing additives. Adheres to impression trays via Polyvinyl Siloxane Adhesive. Meets DIN, ISO, and ADA standards.

Indications for Use

Indicated for patients requiring dental impressions for inlay, onlay, crown, bridge preparations, or edentulous jaw assessments.

Regulatory Classification

Identification

Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.

Special Controls

*Classification.* Class II (Special Controls).

Predicate Devices

• Permagum® (K812116)
• Permagum® Garant Light (K890720)
• Permagum® Adhesive (K881838)

Submission Summary (Full Text)

{0}

MAR 15 1996
K960547
U

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

ESPE is submitting a 510(k) premarket notification for modifications to its 510(k) submissions for silicone impression material, tradenamed Permagum® (K812116) and Permagum® Garant Light (K890720), to create slightly modified impression material, referred to by the tradenames Dimension® Penta and Dimension® Garant L. For Dimension® Penta, the reason for this modification is solely to improve user convenience by allowing mixing of the impression material through use of a free-standing electronic mixing apparatus (Pentamix) and to enhance the stability of the impression material. For Dimension® Garant L, the reason for this modification is also to enhance user convenience by allowing mixing and dispensing of the impression material through use of a hand-held automatic mixing and dispensing apparatus (Garant Dispenser). Dimension® Penta and Dimension® Garant L are both polyvinyl siloxane impression material, composed of a base paste and catalyst, used to make impressions of inlay, onlay, crown and bridge preparations, and edentulous jaws.

ESPE's 510(k) submission also includes adhesive material, tradenamed Polyvinyl Siloxane Adhesive, which is a modification of ESPE's previously cleared Permagum® Adhesive (K881838). The reason for the modification in adhesive material is to enhance the user's ability to create a uniform layer of the adhesive on the tray, to enhance the product's adhesion power and to

WAD1A/A25345.1
- 2 -

{1}

accommodate workplace preferences. Polyvinyl Siloxane Adhesive is intended to assure adhesion of impression material to the impression tray and to avoid deformation during impression taking.

For Dimension® Penta and Dimension® Garant L, ESPE is claiming substantial equivalence to its previously cleared Permagum® and Permagum® Garant Light products, respectively. Both sets of products have the same intended use and the same principal ingredient composition. The percentage at which certain components are present in the impression material, however, has been changed in order to improve product viscosity and mixability of the impression material to enable use of the products in conjunction with an automatic mixing apparatus. In addition, several new pigments have been added to the base paste and catalyst to allow for varying impression colors. Finally, several ingredients at relatively insignificant amounts have been added to the new material in order to enhance product stability and mixability.

For Polyvinyl Siloxane Adhesive, ESPE is claiming substantial equivalence to its previously cleared Permagum® Adhesive. Both products have the same intended use, and two of the three product ingredients remain the same. The percentage at which two of the three product components are present in the adhesive material, however, has been slightly changed in order to

WADIA/A25345.1
- 3 -

{2}

enhance the user's ability to create a uniform layer of the adhesive on the tray, and also to enhance the product's overall adhesion power. In addition, one ingredient has been substituted for another in order to accommodate workplace preferences.

To support substantial equivalence to predicate products, the physical and performance characteristics of Dimension® Penta have been compared to those of Permagum®, and the physical and performance characteristics of Dimension® Garant L to those of Permagum® Garant Light. The relevant performance characteristic of Polyvinyl Siloxane Adhesive (adhesion power) has been compared to that of Permagum® Adhesive. Dimension® Penta and Dimension® Garant L meet the requirements of relevant DIN, ISO and ADA standards for impression material.

ESPE's 510(k) has been submitted on February 5, 1996, by Dr. Barbara Wagner at Am Griesberg 2, D-82229 Seefeld, Germany (011-49-8152-700395).

WA01A/A25345.1