SATLEC PROPHY UNIT PU 3055
Device Facts
| Record ID | K852521 |
|---|---|
| Device Name | SATLEC PROPHY UNIT PU 3055 |
| Applicant | Spelna, Inc. |
| Product Code | KOJ · Dental |
| Decision Date | Jul 31, 1985 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.6080 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An airbrush is an AC-powered device intended for use in conjunction with articulation paper. The device uses air-driven particles to roughen the surfaces of dental restorations. Uneven areas of the restorations are then identified by use of articulation paper.
Special Controls
The special control for this device is International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, “Medical Electrical Equipment—Part 1: General Requirements for Safety.”
