Abiomed Periotemp(Tm) Probe
FDA 510(k) K885075 · Abiomed, Inc.
510(k) numberK885075
Submission
- Device name
- Abiomed Periotemp(Tm) Probe
- Applicant
- Abiomed, Inc.
Danvers, MA, US - Received
- December 8, 1988
- Decision date
- February 13, 1989
- 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 |
| 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 |
| K872215 | Perio-TestEIL · Traditional | Dr. Bernard Loewenthal | 07/10/1987SE |
| K822793 | Pio Root Canal IndicatorEIL · Traditional | National Patent Development Corp. | 10/22/1982SE |
More from National Patent Development Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K252766 | 14Fr Low Profile Introducer KitDYB · Special | 10/08/2025SE |
| K241708 | Abiomed 14Fr Low Profile Introducer KitDYB · Traditional | 08/06/2024SE |
| K221294 | preCARDIA Occlusion SystemMJN · Traditional | 06/30/2023SESU |
| K223161 | OXY-1 SystemDTZ · Traditional | 02/23/2023SE |
| K222113 | Abiomed 14Fr Low Profile Introducer SetDYB · Traditional | 10/13/2022SE |
| K202330 | Impella XR Sheath SetDYB · Traditional | 12/07/2020SE |
| K200109 | OXY-1 SystemDTZ · Traditional | 10/23/2020SE |
| K201116 | Abiomed 23 Fr SheathDYB · Traditional | 06/15/2020SE |
| K192769 | Impella CP IntroducerDYB · Traditional | 11/18/2019SE |
| K112892 | Impella 2.5 Plus CatheterPBL · Special | 09/06/2012SESU |
Questions and answers
When was Abiomed Periotemp(Tm) Probe cleared by the FDA?
Abiomed Periotemp(Tm) Probe (K885075) received a 510(k) decision of Substantially Equivalent on February 13, 1989, 67 days after the submission was received.
What is the product code of K885075?
The FDA product code is EIL – Gauge, Depth, Instrument, Dental, a Class I (low risk) device regulated under 21 CFR 872.4565.