EID — Syringe, Restorative And Impression Material Class I
FDA product code EID covers "Syringe, Restorative And Impression Material", a Class I medical device regulated under 21 CFR 872.4565. Submissions are reviewed by the Dental panel. At least 13 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- EID
- Device Class
- Class I
- Regulation Number
- 872.4565
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K941431 | bio-interfaces | BONE GRAFT DELIVERY SYRINGES | July 12, 1994 |
| K913974 | centrix | ACCESS IMPRESSION BARREL | February 25, 1992 |
| K873153 | dentsply intl | CAULK'S VPS CARTRIDGE SYSTEM | September 16, 1987 |
| K871937 | dentsply intl | IMPRESSION SYRINGE | June 5, 1987 |
| K863998 | coltene | COLTENE JET-MIXER | October 30, 1986 |
| K853282 | centrix | CENTRIX RIBBON TUBES | August 23, 1985 |
| K851386 | unitek | UNITEK DISPOSABLE IMPRESSION SYRINGE | April 29, 1985 |
| K812680 | g-c intl | G-C IMPRESSION SYRINGE | October 6, 1981 |
| K812277 | caulk co., div. dentsply | PRISMA-FIL COMPULES | September 8, 1981 |
| K811582 | cavitron | THE PLACER | July 28, 1981 |
| K781977 | lee pharmaceuticals | APPLICATOR, LEE IMPRESSION | December 20, 1978 |
| K770931 | espe gmbh (us) | APPLIC SYSTEM APPLIER, ESPE | June 3, 1977 |
| K770941 | espe gmbh (us) | APPLIC SYSTEM ACTIVATOR, ESPE | June 2, 1977 |