Product code ECB
- Device name
- Unit, Syringe, Air And/Or Water
- 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 |
|---|---|---|---|
| K942519 | UNI-SYRINGE, UNI-TIP AND ACCESS SYRINGE TIPS | Bull Frog Mfg. Co. | 1994-08-23 |
| K931772 | SURETIP SYRINGE TIP COVER | Western M/D, Inc. | 1994-03-07 |
| K931137 | DENTAL SYRINGE TIP | A-Dec, Inc. | 1993-11-29 |
| K923876 | RISKONTROL SINGLE USE | Riskontrol | 1993-04-05 |
| K923285 | PRO-TIP DISPOSABLE 3/1 SYRINGE NOZZLE | Smith & Nephew, Inc. | 1992-09-15 |
| K920499 | SANI-TIP | Dw Industries, Inc. | 1992-05-03 |
| K911756 | POSTERIOR NASAL EPISTAXIS INSTRUMENTS | Richard Wolf Medical Instruments Corp. | 1991-10-24 |
| K890290 | BRACE (ORAFIX SPECIAL) | Norcliff Thayer, Inc. | 1989-03-29 |
| K863024 | SERINGA TRIPLICE S.L. | Sds Dental, Inc. | 1986-09-25 |
| K854699 | TUBING SYRING | Almore Intl., Inc. | 1986-01-06 |
| K801686 | SPACELINE THREE WAY SYRINGE | Pacific Dental Corp. | 1980-08-04 |
| K781594 | DENTAL WARM WATER IRRIGATING SYSTEM | Rama Corp. | 1978-12-04 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 30810021439403 | DCI | DCI International, LLC | 2025-11-19 |
| 10732224001705 | Sparkle Air Water Syringe Tips | CROSSTEX INTERNATIONAL, INC. | 2023-07-17 |
| 10732224001699 | Sparkle Air Water Syringe Tips | CROSSTEX INTERNATIONAL, INC. | 2023-07-17 |
| 10732224001675 | Sparkle Air Water Syringe Tips | CROSSTEX INTERNATIONAL, INC. | 2023-07-17 |
| H66810047101 | Prehma | Keystone Industries | 2022-11-30 |
| H66810045101 | Prehma | Keystone Industries | 2022-11-30 |
| 10732224001682 | Sparkle™ AirWater Syringe Tips | CROSSTEX INTERNATIONAL, INC. | 2022-09-29 |
| 10818207024326 | Vista Metal Syringe tip | Vista Dental | 2022-09-01 |
| 10818207024319 | Vista Metal Syringe tip | Vista Dental | 2022-09-01 |
| 10818207024302 | Vista Two Button Air/Water Syringe | Vista Dental | 2022-09-01 |
| 10818207024296 | Vista One Button Air/Water Syringe Kit | Vista Dental | 2022-09-01 |
| 10818207024197 | "SI-XL Length (3.5"") Stropko Precision Irrigator" | Vista Dental | 2022-09-01 |
| 10818207024180 | "SI-OL Length (2.0"") Stopko Precision Irrigator" | Vista Dental | 2022-09-01 |
| 10194665001971 | A-dec | A-DEC, INC. | 2022-08-15 |
| 10686864057274 | MEDICOM SAFEJET | AMD Medicom Inc | 2021-05-13 |
| 10304040051570 | Henry Schein | HENRY SCHEIN, INC. | 2020-12-28 |
| 10304040051563 | Henry Schein | HENRY SCHEIN, INC. | 2020-12-28 |
| 10686864054914 | MEDICOM PRO-TIP TURBO | AMD Medicom Inc | 2019-03-18 |
| 10686864054907 | MEDICOM PRO-TIP TURBO | AMD Medicom Inc | 2019-03-01 |
| 10304040051556 | Henry Schein | HENRY SCHEIN, INC. | 2018-09-24 |
| 10304040051433 | Henry Schein | HENRY SCHEIN, INC. | 2018-09-24 |
| 10304040051808 | Henry Schein | HENRY SCHEIN, INC. | 2018-09-24 |
| 10304040051792 | Henry Schein | HENRY SCHEIN, INC. | 2018-09-24 |
| 10304040051785 | Henry Schein | HENRY SCHEIN, INC. | 2018-09-24 |
| 10304040051778 | Henry Schein | HENRY SCHEIN, INC. | 2018-09-24 |
| 10304040051761 | Henry Schein | HENRY SCHEIN, INC. | 2018-09-24 |
| 10304040051754 | Henry Schein | HENRY SCHEIN, INC. | 2018-09-24 |
| 10304040051587 | Henry Schein | HENRY SCHEIN, INC. | 2018-09-24 |
| 10381780506058 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-09-12 |
| 10381780506041 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-09-12 |