GENERAL PURPOSE DENTAL TRAY

K962527 · Medcare Medical Group, Inc. · EIA · Aug 1, 1996 · Dental

Device Facts

• Record ID: K962527
• Device Name: GENERAL PURPOSE DENTAL TRAY
• Applicant: Medcare Medical Group, Inc.
• Product Code: EIA · Dental
• Decision Date: Aug 1, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1

Intended Use

The General Purpose Dental Tray is a single patient, single use, disposable device which is intended to conveniently provide general use auxiliary components for the administration of dental procedures.

Device Story

General Purpose Dental Tray; pre-packaged kit containing auxiliary components for dental procedures; single-use, disposable, sterile; used in dental clinics; provides convenience by consolidating commonly used items; facilitates dental procedure administration.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Single-use, disposable, sterile kit; contains various auxiliary dental components; customizable component selection.

Indications for Use

Indicated for use in dental procedures as a convenient, single-use, sterile kit containing auxiliary components for patients undergoing general dental care.

Regulatory Classification

Identification

A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.

Predicate Devices

• Sterile Dental Systems, Inc. Operative Pack

Submission Summary (Full Text)

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K962527

AUG - I 1996

(I) 510(k) Summary:

This summary is submitted in conformance with the format described in the 21 CFR Part 807.92 interim rule dated April 28, 1992.

(1) Submitted By:

MedCare Medical Group, Inc.
234 Old Homestead Highway
E. Swanzey, NH 03446

Contact Person:

Craig J. Bell
Director of Research and Development
[phone]

(2) Name of Device:

General Purpose Dental Tray

Classification Name:

Unknown

(3) Identification of Predicate Devices:

Sterile Dental Systems, Inc.
Operative Pack

Sterile Concepts
Richmond, VA 23234

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(4) **Description of Device Subject to Premarket Notification:**

The General Purpose Dental Tray is intended to conveniently provide the auxiliary components utilized during general dental procedures. The components are items that are commonly used during a variety of dental procedures. The general Purpose Dental Tray provides the convenience of having these commonly used items packaged in a single package, sterile, and ready to use. The kits are provided sterile, disposable, and for single patient use.

(5) **Intended Use of the Device:**

The General Purpose Dental Tray is a single patient, single use, disposable device which is intended to conveniently provide general use auxiliary components for the administration of dental procedures.

(6) **Technological Characteristics**

The MedCare General Purpose Dental Tray is similar to the predicate device in that both of the device provide a variety of auxiliary components for the convenient administration of dental procedures. Both devices provide flexibility in componentry selection for kit customization, which provides the maximum convenience for the customer.