EHK · Cup, Prophylaxis
Dental · 21 CFR 872.6290 · Class 1
Overview
| Product Code | EHK |
|---|---|
| Device Name | Cup, Prophylaxis |
| Regulation | 21 CFR 872.6290 |
| Device Class | Class 1 |
| Review Panel | Dental |
| GMP Exempt | Yes |
Identification
A prophylaxis cup is a device made of rubber intended to be held by a dental handpiece and used to apply polishing agents during prophylaxis (cleaning). The dental handpiece spins the rubber cup holding the polishing agent and the user applies it to the teeth to remove debris.
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 (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K953628 | PROPHY ANGLE | Rolence Enterprise Co. , Ltd. | Sep 29, 1995 | SESE |
| K951016 | DISPOSABLE PROPHYLAXIS ANGLE | Preventive Technologies, Inc. | May 2, 1995 | SESE |
| K900507 | DISPOSABLE SCREW TYPE PROPHY BRUSH | Dentsply Intl. | Apr 10, 1990 | SESE |
| K864059 | DENTAL PROPHY CUPS (VARIOUS TYPES) | Mission White Dental, Inc. | Nov 19, 1986 | SESE |
| K803155 | PROPHYLAXIS CUP. | Teledyne Densco | Jan 8, 1981 | SESE |
| K790723 | PROPHYLAXIS CUPS AND POLISHERS | Young Dental Manufacturing Co. 1, LLC | Jun 15, 1979 | SESE |
| K780198 | PROPHY CUPS, R&R | Ransom and Randolph | Feb 16, 1978 | SESE |
| K770556 | PRO-KUP | Dental Control Products | Mar 24, 1977 | SESE |
Top Applicants
- Dental Control Products — 1 clearance
- Dentsply Intl. — 1 clearance
- Mission White Dental, Inc. — 1 clearance
- Preventive Technologies, Inc. — 1 clearance
- Ransom and Randolph — 1 clearance
