21 CFR 872.6080 — Airbrush
Dental (DE) · Subpart G—Miscellaneous Devices · § 872.6080
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.
Classification Rationale
Class II. 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.”
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KOJ | Airbrush | 2 | 48 | 3rd Party |
| PIP | Prophy Powder, Airbrush Accessory | 2 | 2 | 3rd Party |
Special Controls
KOJ — Airbrush
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.”
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