FDA product code EIC: Syringe, Periodontic, Endodontic, Irrigating
EIC is the FDA product code for syringe, periodontic, endodontic, irrigating. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel. FDA has cleared 16 510(k) submissions under EIC, from 10 different applicants. The average 510(k) review took 33 days (median 22). FDA has posted 1 recall for EIC devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Syringe, Periodontic, Endodontic, Irrigating |
| 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 EIC clearance
Top EIC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| National Patent Development Corp. | 4 | 1980-07-21 |
| Aus-Tex Dental Mfg. & Design | 3 | 1981-07-15 |
| Dental Development Services, Inc. | 2 | 1980-01-04 |
| Dentsply Intl. | 1 | 1997-06-30 |
| Smith & Nephew, Inc. | 1 | 1986-11-18 |
5 more applicants have EIC clearances. See the full list in Caduvo.
Most recent EIC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K972234 | Dentsply Intl. | RCT GEL ROOT CANAL THERAPY GEL | 1997-06-30 | 14 |
| K864307 | Smith & Nephew, Inc. | MAX-I-PROBE PERIDONTAL/ENDODONTIC PROBE(TM) (MODI) | 1986-11-18 | 15 |
| K861846 | Solar Dental Co., Inc. | HYDRON ROOT CANAL FILLING & MARK IV STARTER KIT | 1986-06-26 | 44 |
| K851944 | Solo Pak Laboratories | MAX-I-PROBE HANDPIECE | 1985-07-01 | 59 |
| K840237 | Smith & Nephew, Mpl Division | MAX-I-PROBE PERIODONTAL ENDODONTIC PROB | 1984-04-05 | 76 |
Recalls for EIC 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 EIC?
EIC is the FDA product code for syringe, periodontic, endodontic, irrigating. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.
What device class is EIC?
Class I, regulation 21 CFR 872.4565. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EIC?
Across 16 cleared submissions the average was 33 days from receipt to decision (median 22).
Which companies have the most EIC clearances?
National Patent Development Corp. (4); Aus-Tex Dental Mfg. & Design (3); Dental Development Services, Inc. (2); Dentsply Intl. (1); Smith & Nephew, Inc. (1).
Have EIC 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 EIC
- Run a recall and safety report across every EIC manufacturer
- Watch product code EIC 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.
All Dental product codes · FDA product code lookup · 510(k) database search · 510(k) review times