FDA product code EIX: Probe, Periodontic
EIX is the FDA product code for probe, periodontic. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel. FDA has cleared 9 510(k) submissions under EIX, from 9 different applicants. The average 510(k) review took 77 days (median 75).
Classification
| Field | Value |
|---|---|
| Device name | Probe, Periodontic |
| Device class | Class I |
| Regulation | 21 CFR 872.4565 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EIX clearance
Top EIX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pro-Dentec | 1 | 1996-04-04 |
| Rms Div. | 1 | 1994-12-14 |
| Pd International AB | 1 | 1994-08-01 |
| Alpkem Corp. | 1 | 1989-02-17 |
| Sweet Micro Systems, Inc. | 1 | 1988-04-12 |
4 more applicants have EIX clearances. See the full list in Caduvo.
Most recent EIX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K960245 | Pro-Dentec | VIP VICTOR INTERACTIVE PROBE | 1996-04-04 | 79 |
| K944848 | Rms Div. | THE VIVACARE T.P.S. PROBE | 1994-12-14 | 75 |
| K936221 | Pd International AB | PROBE TIP/PERI PROBE/PERI PROBE COMP. | 1994-08-01 | 217 |
| K890333 | Alpkem Corp. | ALBUMIN REAGENT | 1989-02-17 | 25 |
| K880827 | Sweet Micro Systems, Inc. | ACCUTEK PERIODONTAL PROBE | 1988-04-12 | 42 |
Recalls for EIX devices
openFDA lists no recalls for product code EIX.
Frequently asked questions
What is FDA product code EIX?
EIX is the FDA product code for probe, periodontic. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.
What device class is EIX?
Class I, regulation 21 CFR 872.4565. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EIX?
Across 9 cleared submissions the average was 77 days from receipt to decision (median 75).
Which companies have the most EIX clearances?
Pro-Dentec (1); Rms Div. (1); Pd International AB (1); Alpkem Corp. (1); Sweet Micro Systems, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EIX
- Run a recall and safety report across every EIX manufacturer
- Watch product code EIX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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