FDA product code EHZ: Evacuator, Oral Cavity
EHZ is the FDA product code for evacuator, oral cavity. It is a Class I device, regulated under 21 CFR 872.6640 and reviewed by the Dental panel. FDA has cleared 17 510(k) submissions under EHZ, from 15 different applicants. The average 510(k) review took 52 days (median 65). FDA has posted 1 recall for EHZ devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Evacuator, Oral Cavity |
| Device class | Class I |
| Regulation | 21 CFR 872.6640 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EHZ clearance
Top EHZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nieusma R & D, Inc. | 2 | 1989-06-23 |
| Dentsply Intl. | 2 | 1979-01-26 |
| Imtec Corp. | 1 | 1997-11-19 |
| Tap Express, Inc. | 1 | 1994-05-18 |
| A & F Products | 1 | 1991-05-15 |
10 more applicants have EHZ clearances. See the full list in Caduvo.
Most recent EHZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K973248 | Imtec Corp. | IMTEC BONE COLLECTOR SYSTEM | 1997-11-19 | 82 |
| K941164 | Tap Express, Inc. | TAP EXPRESS EJECTOR | 1994-05-18 | 68 |
| K911072 | A & F Products | SUPER EVACRETRACTOR, DISPOSABLE ORAL EVACUATOR | 1991-05-15 | 65 |
| K903718 | Cygnus Instruments, Inc. | OROSCOPE MODEL NUMBER COS-100 | 1990-11-09 | 85 |
| K892882 | Nieusma R & D, Inc. | DENTAL SANI-SLEEVE STERILE 100MM X 2200MM #1102 | 1989-06-23 | 78 |
Recalls for EHZ devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-11-02.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code EHZ?
EHZ is the FDA product code for evacuator, oral cavity. It is a Class I device, regulated under 21 CFR 872.6640 and reviewed by the Dental panel.
What device class is EHZ?
Class I, regulation 21 CFR 872.6640. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EHZ?
Across 17 cleared submissions the average was 52 days from receipt to decision (median 65).
Which companies have the most EHZ clearances?
Nieusma R & D, Inc. (2); Dentsply Intl. (2); Imtec Corp. (1); Tap Express, Inc. (1); A & F Products (1).
Have EHZ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2022-11-02.
Next steps
- Run an FDA pathway report with predicate devices for product code EHZ
- Run a recall and safety report across every EHZ manufacturer
- Watch product code EHZ 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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