EIC
16 FDA 510(k) clearances · Product code
23 daysmedian time to decision
66 days90th percentile
16clearances measured
FDA profile
- Official device name
- Syringe, Periodontic, Endodontic, Irrigating
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.4565
- Medical specialty
- Dental
- Adverse events (MAUDE)
- 2020: 35 · 2021: 76 · 2023: 19 · 2024: 22 · 2025: 37 · 2026: 18
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| RCT GEL ROOT CANAL THERAPY GEL (K972234) | Dentsply Intl. | 1997-06-30 |
| MAX-I-PROBE PERIDONTAL/ENDODONTIC PROBE(TM) (MODI) (K864307) | Smith & Nephew, Inc. | 1986-11-18 |
| HYDRON ROOT CANAL FILLING & MARK IV STARTER KIT (K861846) | Solar Dental Co., Inc. | 1986-06-26 |
| MAX-I-PROBE HANDPIECE (K851944) | Solo Pak Laboratories | 1985-07-01 |
| MAX-I-PROBE PERIODONTAL ENDODONTIC PROB (K840237) | Smith & Nephew, Mpl Division | 1984-04-05 |
| R & S SERIES FITTING TOOLS (K811889) | Suncoast Dental Corp. | 1981-07-24 |
| WATER PISTOL (K811594) | Aus-Tex Dental Mfg. & Design | 1981-07-15 |
| ROOT CANAL FILLING APPLICATOR NEEDLES (K801484) | National Patent Development Corp. | 1980-07-21 |
| MARK IV SYRINGE (K801483) | National Patent Development Corp. | 1980-07-21 |
| EPIC CANNULA (K792578) | Dental Development Services, Inc. | 1980-01-04 |
| ENDOVAGE SYRINGE (K792577) | Dental Development Services, Inc. | 1980-01-04 |
| CENTRIX MKIV ENDODONTIC DELIVERY (K792461) | Centrix, Inc. | 1979-12-19 |
| GUTTA GUN (K771406) | Aus-Tex Dental Mfg. & Design | 1977-08-26 |
| SYRINGE, ENDODONTIC, W/PERFORATED NEEDLE (K770967) | National Patent Development Corp. | 1977-06-20 |
| ENDOGATOR (K770813) | Aus-Tex Dental Mfg. & Design | 1977-05-20 |
| SYRINGE, ENDODONTIC W/NOTCHED TIP NEEDLE (K770642) | National Patent Development Corp. | 1977-04-15 |
Track EIC automatically
Every clearance here is in the API, with alerts when new ones post.