EHM · Strip, Polishing Agent
Dental · 21 CFR 872.6010 · Class 1
Overview
| Product Code | EHM |
|---|---|
| Device Name | Strip, Polishing Agent |
| Regulation | 21 CFR 872.6010 |
| Device Class | Class 1 |
| Review Panel | Dental |
| GMP Exempt | Yes |
Identification
An abrasive device and accessories is a device constructed of various abrasives, such as diamond chips, that are glued to shellac-based paper. The device is intended to remove excessive restorative materials, such as gold, and to smooth rough surfaces from oral restorations, such as crowns. The device is attached to a shank that is held by a handpiece. The device includes the abrasive disk, guard for an abrasive disk, abrasive point, polishing agent strip, and polishing wheel.
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 (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K821364 | PROFLEX FLEXIBLE SCALER | Teledyne Densco | May 28, 1982 | SESE |
| K790598 | RUWA FINISHING STRIPS | Howmedica Corp. | May 21, 1979 | SESE |
Top Applicants
- Teledyne Densco — 1 clearance
- Howmedica Corp. — 1 clearance
