Perio-Test
FDA 510(k) K872215 · Dr. Bernard Loewenthal
510(k) numberK872215
Submission
- Device name
- Perio-Test
- Applicant
- Dr. Bernard Loewenthal
Portsmouth, NH, US - Received
- June 9, 1987
- Decision date
- July 10, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EIL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K911643 | Abiodent Periotemp(R) SystemEIL · Traditional | Abiomed, Inc. | 07/09/1991SE |
| K890493 | Florida Probe Periodontal ProbeEIL · Traditional | Florida Probe Corp. | 03/13/1989SE |
| K885075 | Abiomed Periotemp(Tm) ProbeEIL · Traditional | Abiomed, Inc. | 02/13/1989SE |
| K884813 | Model 200A Electronic Force-Sensing ProbeEIL · Traditional | Vine Valley Research | 01/05/1989SE |
| K880209 | Periodontal Probe - AutoprobeEIL · Traditional | Dentsply Intl. | 04/27/1988SE |
| K872098 | Cremeen Alveolar Bone CaliperEIL · Traditional | Bowen & Company, Inc. | 07/31/1987SE |
| K822793 | Pio Root Canal IndicatorEIL · Traditional | National Patent Development Corp. | 10/22/1982SE |
Questions and answers
When was Perio-Test cleared by the FDA?
Perio-Test (K872215) received a 510(k) decision of Substantially Equivalent on July 10, 1987, 31 days after the submission was received.
What is the product code of K872215?
The FDA product code is EIL – Gauge, Depth, Instrument, Dental, a Class I (low risk) device regulated under 21 CFR 872.4565.