# Dental Devices; Endodontic Dry Heat Sterilizer
> **Food and Drug Administration** · Final rule. · Published 1997-01-21 · Effective 1997-01-21 · 62 FR 2900
## Document
- **Document number:** 97-1336
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 62 FR 2900
- **CFR reference:** 21 CFR 872
- **Publication date:** 1997-01-21
- **Effective date:** 1997-01-21
- **HHS docket:** Docket No. 95N-0033
## Abstract

The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the endodontic dry heat sterilizer, a medical device. Commercial distribution of this device must cease, unless a manufacturer or importer has filed with FDA a PMA or a notice of completion of a PDP for its version of the endodontic dry heat sterilizer within 90 days of the effective date of this regulation. This regulation reflects FDA's exercise of its discretion to require a PMA or notice of completion of a PDP for the preamendments device.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/1997/01/21/97-1336/dental-devices-endodontic-dry-heat-sterilizer)
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