← Product Code [EIA](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EIA) · K962527 # GENERAL PURPOSE DENTAL TRAY (K962527) _Medcare Medical Group, Inc. · EIA · Aug 1, 1996 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EIA/K962527 ## Device Facts - **Applicant:** Medcare Medical Group, Inc. - **Product Code:** [EIA](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EIA.md) - **Decision Date:** Aug 1, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.6640 - **Device Class:** Class 1 - **Review Panel:** Dental ## Indications for 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. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 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 (603)352-3230 (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 Page 9 of 12 {1} Page 10 of 12 (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. --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EIA/K962527](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EIA/K962527) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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