# Medical Devices; Exemption From Premarket Notification; Class II Devices; Optical Impression Systems for Computer Assisted Design and Manufacturing
> **Food and Drug Administration** · Final rule. · Published 2003-04-22 · Effective 2003-04-22 · 68 FR 19736
## Document
- **Document number:** 03-9869
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 68 FR 19736
- **CFR reference:** 21 CFR 872
- **Publication date:** 2003-04-22
- **Effective date:** 2003-04-22
- **HHS docket:** Docket No. 02P-0494
## Abstract

The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from the premarket notification requirements for data acquisition units for ceramic dental restoration systems. This rule exempts from premarket notification data acquisition units for ceramic dental restoration systems and establishes a guidance document as a special control for this device. FDA is publishing this order in accordance with the Food and Drug Administration Modernization Act of 1997 (FDAMA).

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2003/04/22/03-9869/medical-devices-exemption-from-premarket-notification-class-ii-devices-optical-impression-systems)
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