Product code EHK
- Device name
- Cup, Prophylaxis
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.6290
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K953628 | PROPHY ANGLE | Rolence Enterprise Co. , Ltd. | 1995-09-29 |
| K951016 | DISPOSABLE PROPHYLAXIS ANGLE | Preventive Technologies, Inc. | 1995-05-02 |
| K900507 | DISPOSABLE SCREW TYPE PROPHY BRUSH | Dentsply Intl. | 1990-04-10 |
| K864059 | DENTAL PROPHY CUPS (VARIOUS TYPES) | Mission White Dental, Inc. | 1986-11-19 |
| K803155 | PROPHYLAXIS CUP. | Teledyne Densco | 1981-01-08 |
| K790723 | PROPHYLAXIS CUPS AND POLISHERS | Young Dental Manufacturing Co. 1, LLC | 1979-06-15 |
| K780198 | PROPHY CUPS, R&R | Ransom and Randolph | 1978-02-16 |
| K770556 | PRO-KUP | Dental Control Products | 1977-03-24 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00840456220504 | JMU | JMU DENTAL, INC | 2026-07-07 |
| 00840456220498 | JMU | JMU DENTAL, INC | 2026-07-07 |
| 00840456220481 | JMU | JMU DENTAL, INC | 2026-07-07 |
| 00840456220474 | JMU | JMU DENTAL, INC | 2026-07-07 |
| 00840456220122 | JMU | JMU DENTAL, INC | 2026-06-25 |
| 00840456220276 | JMU | JMU DENTAL, INC | 2026-06-25 |
| 00840456220269 | JMU | JMU DENTAL, INC | 2026-06-25 |
| 00840456220252 | JMU | JMU DENTAL, INC | 2026-06-25 |
| 00840456220245 | JMU | JMU DENTAL, INC | 2026-06-25 |
| 00840456220238 | JMU | JMU DENTAL, INC | 2026-06-25 |
| 00840456220221 | JMU | JMU DENTAL, INC | 2026-06-25 |
| 00840456220207 | JMU | JMU DENTAL, INC | 2026-06-25 |
| 00840456220115 | JMU | JMU DENTAL, INC | 2026-06-25 |
| 00840456220139 | JMU | JMU DENTAL, INC | 2026-06-25 |
| 00840456220146 | JMU | JMU DENTAL, INC | 2026-06-25 |
| 00840456220153 | JMU | JMU DENTAL, INC | 2026-06-25 |
| 00840456220160 | JMU | JMU DENTAL, INC | 2026-06-25 |
| 00840456220177 | JMU | JMU DENTAL, INC | 2026-06-25 |
| 00840456220184 | JMU | JMU DENTAL, INC | 2026-06-25 |
| 00840456220191 | JMU | JMU DENTAL, INC | 2026-06-25 |
| 00840456220214 | JMU | JMU DENTAL, INC | 2026-06-25 |
| 07897990300103 | PROPHY BRUSHES | TDV DENTAL LTDA | 2026-05-18 |
| 07897990300110 | PROPHY BRUSHES | TDV DENTAL LTDA | 2026-05-18 |
| 07897990300127 | PROPHY BRUSHES | TDV DENTAL LTDA | 2026-05-18 |
| 07897990300219 | PROPHY BRUSHES | TDV DENTAL LTDA | 2026-05-18 |
| 07897990300233 | PROPHY BRUSHES | TDV DENTAL LTDA | 2026-05-18 |
| 07897990300264 | PROPHY BRUSHES | TDV DENTAL LTDA | 2026-05-18 |
| 07897990300271 | PROPHY BRUSHES | TDV DENTAL LTDA | 2026-05-18 |
| 07897990300288 | PROPHY BRUSHES | TDV DENTAL LTDA | 2026-05-18 |
| EZPF85255020 | HELMUT ZEPF | Helmut Zepf Medizintechnik GmbH | 2022-12-09 |