EID
13 FDA 510(k) clearances · Product code
20 daysmedian time to decision
110 days90th percentile
13clearances measured
FDA profile
- Official device name
- Syringe, Restorative And Impression Material
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.4565
- Medical specialty
- Dental
- Adverse events (MAUDE)
- 2002: 1
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 |
|---|---|---|
| BONE GRAFT DELIVERY SYRINGES (K941431) | Bio-Interfaces, Inc. | 1994-07-12 |
| ACCESS IMPRESSION BARREL (K913974) | Centrix, Inc. | 1992-02-25 |
| CAULK'S VPS CARTRIDGE SYSTEM (K873153) | Dentsply Intl. | 1987-09-16 |
| IMPRESSION SYRINGE (K871937) | Dentsply Intl. | 1987-06-05 |
| COLTENE JET-MIXER (K863998) | Coltene, Inc. | 1986-10-30 |
| CENTRIX RIBBON TUBES (K853282) | Centrix, Inc. | 1985-08-23 |
| UNITEK DISPOSABLE IMPRESSION SYRINGE (K851386) | Unitek Corp. | 1985-04-29 |
| G-C IMPRESSION SYRINGE (K812680) | G-C Intl. Corp. | 1981-10-06 |
| PRISMA-FIL COMPULES (K812277) | Caulk Co., Div. Dentsply | 1981-09-08 |
| THE PLACER (K811582) | Cavitron Corp. | 1981-07-28 |
| APPLICATOR, LEE IMPRESSION (K781977) | Lee Pharmaceuticals | 1978-12-20 |
| APPLIC SYSTEM APPLIER, ESPE (K770931) | Espe GmbH (Us) | 1977-06-03 |
| APPLIC SYSTEM ACTIVATOR, ESPE (K770941) | Espe GmbH (Us) | 1977-06-02 |
Track EID automatically
Every clearance here is in the API, with alerts when new ones post.