PFL · Intraoral, Dental Foam Protector
Dental · 21 CFR 872.6890 · Class 1
Overview
| Product Code | PFL |
|---|---|
| Device Name | Intraoral, Dental Foam Protector |
| Regulation | 21 CFR 872.6890 |
| Device Class | Class 1 |
| Review Panel | Dental |
Identification
Intraoral dental wax is a device made of wax intended to construct patterns from which custom made metal dental prostheses, such as crowns and bridges, are cast. In orthodontic dentistry, the device is intended to make a pattern of a patient's bite to make study models of the teeth.
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. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K131396 | WIRED MOUTH PROTECTOR (WMP) | Elba Laboratories, Inc. | Sep 30, 2013 | SESE |
Top Applicants
- Elba Laboratories, Inc. — 1 clearance
