Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart D — Prosthetic Devices](/submissions/DE/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 872.3285](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3285) → EHP — Clasp, Preformed

# EHP · Clasp, Preformed

_Dental · 21 CFR 872.3285 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EHP

## Overview

- **Product Code:** EHP
- **Device Name:** Clasp, Preformed
- **Regulation:** [21 CFR 872.3285](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3285)
- **Device Class:** 1
- **Review Panel:** [Dental](/submissions/DE)

## Identification

A preformed clasp or a preformed wire clasp is a prefabricated device made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended to be incorporated into a dental appliance, such as a partial denture, to help stabilize the appliance in the patient's mouth by fastening the appliance to an adjacent tooth.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

## Recent Cleared Devices (8 of 8)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K022032](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EHP/K022032.md) | ACETAL | Inovativ, LLC | Aug 29, 2002 | SESE |
| [K983558](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EHP/K983558.md) | ACETAL DENTAL/PREFORMED CLASP | Dentamax, Inc. | Jan 7, 1999 | SESE |
| [K974622](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EHP/K974622.md) | DENTAL D | Micro Dental Laboratories | Feb 10, 1998 | SESE |
| [K955946](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EHP/K955946.md) | ACETAL DENTAL/PREFORMED CLASP | Pressing DI Monticelli Rag. Stefano | Dec 11, 1995 | SESE |
| [K954971](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EHP/K954971.md) | ACETAL DENTAL/PREFORMED CLASP | B & H Technical Services , Ltd. | Dec 11, 1995 | SESE |
| [K854765](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EHP/K854765.md) | INSTA-TOOTH SPLINT BAR WITH & WITHOUT TEETH | C&C Systems, Inc. | Jun 13, 1986 | SESE |
| [K800575](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EHP/K800575.md) | VACUDENT LUMIX 70 | Vacudent Sales Corp. | May 20, 1980 | SESE |
| [K800574](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EHP/K800574.md) | VACUDENT LUMIX 65 | Vacudent Sales Corp. | May 20, 1980 | SESE |

## Top Applicants

- Vacudent Sales Corp. — 2 clearances
- Pressing DI Monticelli Rag. Stefano — 1 clearance
- Micro Dental Laboratories — 1 clearance
- Inovativ, LLC — 1 clearance
- Dentamax, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EHP](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EHP)

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