FDA Product Code
FDA Product Code EIC — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.4565
510(k) Clearances — 16 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K972234 | RCT GEL ROOT CANAL THERAPY GEL | Dentsply Intl. | 1997-06-30 | Traditional | PDF ↗ |
| K864307 | MAX-I-PROBE PERIDONTAL/ENDODONTIC PROBE(TM) (MODI) | Smith & Nephew, Inc. | 1986-11-18 | Traditional | PDF ↗ |
| K861846 | HYDRON ROOT CANAL FILLING & MARK IV STARTER KIT | Solar Dental Co., Inc. | 1986-06-26 | Traditional | PDF ↗ |
| K851944 | MAX-I-PROBE HANDPIECE | Solo Pak Laboratories | 1985-07-01 | Traditional | PDF ↗ |
| K840237 | MAX-I-PROBE PERIODONTAL ENDODONTIC PROB | Smith & Nephew, Mpl Division | 1984-04-05 | Traditional | PDF ↗ |
| K811889 | R & S SERIES FITTING TOOLS | Suncoast Dental Corp. | 1981-07-24 | Traditional | PDF ↗ |
| K811594 | WATER PISTOL | Aus-Tex Dental Mfg. & Design | 1981-07-15 | Traditional | PDF ↗ |
| K801483 | MARK IV SYRINGE | National Patent Development Corp. | 1980-07-21 | Traditional | PDF ↗ |
| K801484 | ROOT CANAL FILLING APPLICATOR NEEDLES | National Patent Development Corp. | 1980-07-21 | Traditional | PDF ↗ |
| K792577 | ENDOVAGE SYRINGE | Dental Development Services, Inc. | 1980-01-04 | Traditional | PDF ↗ |
| K792578 | EPIC CANNULA | Dental Development Services, Inc. | 1980-01-04 | Traditional | PDF ↗ |
| K792461 | CENTRIX MKIV ENDODONTIC DELIVERY | Centrix, Inc. | 1979-12-19 | Traditional | PDF ↗ |
| K771406 | GUTTA GUN | Aus-Tex Dental Mfg. & Design | 1977-08-26 | Traditional | PDF ↗ |
| K770967 | SYRINGE, ENDODONTIC, W/PERFORATED NEEDLE | National Patent Development Corp. | 1977-06-20 | Traditional | PDF ↗ |
| K770813 | ENDOGATOR | Aus-Tex Dental Mfg. & Design | 1977-05-20 | Traditional | PDF ↗ |
| K770642 | SYRINGE, ENDODONTIC W/NOTCHED TIP NEEDLE | National Patent Development Corp. | 1977-04-15 | Traditional | PDF ↗ |
Product code EIC · Class I · Dental. Data: openFDA.