FDA product code EJR: Agent, Polishing, Abrasive, Oral Cavity
EJR is the FDA product code for agent, polishing, abrasive, oral cavity. It is a Class I device, regulated under 21 CFR 872.6030 and reviewed by the Dental panel. FDA has cleared 77 510(k) submissions under EJR, from 54 different applicants. The average 510(k) review took 96 days (median 82). FDA has posted 1 recall for EJR devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Agent, Polishing, Abrasive, Oral Cavity |
| Device class | Class I |
| Regulation | 21 CFR 872.6030 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
510(k) clearances per year for EJR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 140 |
Compare with all 510(k) review times · Search every EJR clearance
Top EJR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Scientific Pharmaceuticals, Inc. | 7 | 1987-11-12 |
| Dentsply Intl. | 5 | 2000-03-24 |
| Pulpdent Corp. | 3 | 1991-05-30 |
| Imd, Inc. | 3 | 1987-02-12 |
| GC America, Inc. | 2 | 2007-04-12 |
49 more applicants have EJR clearances. See the full list in Caduvo.
Most recent EJR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K171189 | E.M.S Electro Medical Systems S.A | AIR-FLOW PLUS Prophylaxis powder | 2017-09-11 | 140 |
| K131760 | Whip-Mix Corp. | WHIP MIX PREPPIES PLUS | 2014-03-26 | 282 |
| K121698 | Dentsply International, Inc. | NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN | 2012-08-06 | 59 |
| K103114 | Osspray, Ltd. | OSSPRAY SYLC CR | 2011-03-14 | 144 |
| K102053 | Sunstar Americas, Inc. | BUTLER CALCI-FLOR PROPHYLAXIS PASTE | 2011-02-03 | 196 |
Recalls for EJR devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-05-13.
| Year | Recalls |
|---|---|
| 2024 | 1 |
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- Q9954 — Oral magnetic resonance contrast agent, per 100 ml
Frequently asked questions
What is FDA product code EJR?
EJR is the FDA product code for agent, polishing, abrasive, oral cavity. It is a Class I device, regulated under 21 CFR 872.6030 and reviewed by the Dental panel.
What device class is EJR?
Class I, regulation 21 CFR 872.6030. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EJR?
Across 77 cleared submissions the average was 96 days from receipt to decision (median 82).
Which companies have the most EJR clearances?
Scientific Pharmaceuticals, Inc. (7); Dentsply Intl. (5); Pulpdent Corp. (3); Imd, Inc. (3); GC America, Inc. (2).
Have EJR devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2024-05-13.
Next steps
- Run an FDA pathway report with predicate devices for product code EJR
- Run a recall and safety report across every EJR manufacturer
- Watch product code EJR 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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