The Vivacare T.P.S. Probe
FDA 510(k) K944848 · Rms Div.
510(k) numberK944848
Submission
- Device name
- The Vivacare T.P.S. Probe
- Applicant
- Rms Div.
Amherst, NY, US - Received
- September 30, 1994
- Decision date
- December 14, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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|---|---|---|---|
| K960245 | Vip Victor Interactive ProbeEIX · Traditional | Pro-Dentec | 04/04/1996SE |
| K936221 | Probe Tip/Peri Probe/Peri Probe Comp.EIX · Traditional | Pd International AB | 08/01/1994SE |
| K890333 | Albumin ReagentEIX · Traditional | Alpkem Corp. | 02/17/1989SE |
| K880827 | Accutek Periodontal ProbeEIX · Traditional | Sweet Micro Systems, Inc. | 04/12/1988SE |
| K875076 | Florida ProbeEIX · Traditional | Florida Probe Corp. | 03/10/1988SE |
| K870280 | Accudent AccuprobeEIX · Traditional | Accudent, Inc. | 06/08/1987SE |
| K871504 | Disposable Periodontal ProbeEIX · Traditional | Periodontal Health Brush, Inc. | 05/06/1987SE |
| K823324 | Dental Instruments - ProbesEIX · Traditional | Miltex, Inc. | 11/24/1982SE |
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Questions and answers
When was The Vivacare T.P.S. Probe cleared by the FDA?
The Vivacare T.P.S. Probe (K944848) received a 510(k) decision of Substantially Equivalent on December 14, 1994, 75 days after the submission was received.
What is the product code of K944848?
The FDA product code is EIX – Probe, Periodontic, a Class I (low risk) device regulated under 21 CFR 872.4565.