Product code EIC
- Device name
- Syringe, Periodontic, Endodontic, Irrigating
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.4565
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K972234 | RCT GEL ROOT CANAL THERAPY GEL | Dentsply Intl. | 1997-06-30 |
| K864307 | MAX-I-PROBE PERIDONTAL/ENDODONTIC PROBE(TM) (MODI) | Smith & Nephew, Inc. | 1986-11-18 |
| K861846 | HYDRON ROOT CANAL FILLING & MARK IV STARTER KIT | Solar Dental Co., Inc. | 1986-06-26 |
| K851944 | MAX-I-PROBE HANDPIECE | Solo Pak Laboratories | 1985-07-01 |
| K840237 | MAX-I-PROBE PERIODONTAL ENDODONTIC PROB | Smith & Nephew, Mpl Division | 1984-04-05 |
| K811889 | R & S SERIES FITTING TOOLS | Suncoast Dental Corp. | 1981-07-24 |
| K811594 | WATER PISTOL | Aus-Tex Dental Mfg. & Design | 1981-07-15 |
| K801483 | MARK IV SYRINGE | National Patent Development Corp. | 1980-07-21 |
| K801484 | ROOT CANAL FILLING APPLICATOR NEEDLES | National Patent Development Corp. | 1980-07-21 |
| K792577 | ENDOVAGE SYRINGE | Dental Development Services, Inc. | 1980-01-04 |
| K792578 | EPIC CANNULA | Dental Development Services, Inc. | 1980-01-04 |
| K792461 | CENTRIX MKIV ENDODONTIC DELIVERY | Centrix, Inc. | 1979-12-19 |
| K771406 | GUTTA GUN | Aus-Tex Dental Mfg. & Design | 1977-08-26 |
| K770967 | SYRINGE, ENDODONTIC, W/PERFORATED NEEDLE | National Patent Development Corp. | 1977-06-20 |
| K770813 | ENDOGATOR | Aus-Tex Dental Mfg. & Design | 1977-05-20 |
| K770642 | SYRINGE, ENDODONTIC W/NOTCHED TIP NEEDLE | National Patent Development Corp. | 1977-04-15 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00371347023466 | Advance Dental Products | The Atlanta Dental Supply Company | 2026-04-14 |
| 16974843120168 | CanalPro Color Syringes | ZOGEAR Medical Co., Ltd. | 2023-04-20 |
| 16974843120175 | CanalPro Color Syringes | ZOGEAR Medical Co., Ltd. | 2023-04-20 |
| 16974843120151 | CanalPro Color Syringes | ZOGEAR Medical Co., Ltd. | 2023-04-20 |
| 16974843120144 | CanalPro Color Syringes | ZOGEAR Medical Co., Ltd. | 2023-04-20 |
| 16974843120137 | CanalPro Color Syringes | ZOGEAR Medical Co., Ltd. | 2023-04-20 |
| 16974843120120 | CanalPro Color Syringes | ZOGEAR Medical Co., Ltd. | 2023-04-20 |
| 16974843120113 | CanalPro Color Syringes | ZOGEAR Medical Co., Ltd. | 2023-04-20 |
| 16974843120106 | CanalPro Color Syringes | ZOGEAR Medical Co., Ltd. | 2023-04-20 |
| 20192253037859 | Monoject | Cardinal Health 200, LLC | 2023-03-10 |
| 00371347005202 | Advance Dental Products | The Atlanta Dental Supply Company | 2023-02-10 |
| 00371347005196 | Advance Dental Products | The Atlanta Dental Supply Company | 2023-02-10 |
| 00371347005141 | Advance Dental Products | The Atlanta Dental Supply Company | 2023-02-10 |
| 00371347005134 | Advance Dental Products | The Atlanta Dental Supply Company | 2023-02-10 |
| 00371347005127 | Advance Dental Products | The Atlanta Dental Supply Company | 2023-02-10 |
| 10304040058876 | Henry Schein | HENRY SCHEIN, INC. | 2020-12-28 |
| 10304040058838 | Henry Schein | HENRY SCHEIN, INC. | 2020-12-28 |
| 08806383500289 | DiaFlex | DiaDent Group International | 2020-05-27 |
| 08806383500272 | DiaFlex | DiaDent Group International | 2020-05-27 |
| 10304040108786 | Henry Schein | HENRY SCHEIN, INC. | 2019-10-28 |
| 10304040108762 | Henry Schein | HENRY SCHEIN, INC. | 2019-10-28 |
| 10304040108755 | Henry Schein | HENRY SCHEIN, INC. | 2019-10-28 |
| 00304040003435 | Henry Schein | HENRY SCHEIN, INC. | 2018-09-24 |
| 00304040017425 | Henry Schein | HENRY SCHEIN, INC. | 2018-09-24 |
| 10884521010444 | Monoject | Cardinal Health, Inc. | 2018-06-30 |
| 40884521010438 | Monoject | Cardinal Health, Inc. | 2018-06-30 |
| 20884521010465 | Monoject | Cardinal Health, Inc. | 2018-06-27 |
| 20884521010458 | Monoject | Cardinal Health, Inc. | 2018-06-27 |
| 20884521195506 | Monoject | Cardinal Health, Inc. | 2018-06-22 |
| 10884521195547 | Monoject | Cardinal Health, Inc. | 2018-06-22 |