Prisma-Fil Compules
FDA 510(k) K812277 · Caulk Co., Div. Dentsply
510(k) numberK812277
Submission
- Device name
- Prisma-Fil Compules
- Applicant
- Caulk Co., Div. Dentsply
Walker, MI, US - Received
- August 13, 1981
- Decision date
- September 8, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EID
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K941431 | Bone Graft Delivery SyringesEID · Traditional | Bio-Interfaces, Inc. | 07/12/1994SE |
| K913974 | Access Impression BarrelEID · Traditional | Centrix, Inc. | 02/25/1992SE |
| K873153 | Caulk's VPS Cartridge SystemEID · Traditional | Dentsply Intl. | 09/16/1987SE |
| K871937 | Impression SyringeEID · Traditional | Dentsply Intl. | 06/05/1987SE |
| K863998 | Coltene Jet-MixerEID · Traditional | Coltene, Inc. | 10/30/1986SE |
| K853282 | Centrix Ribbon TubesEID · Traditional | Centrix, Inc. | 08/23/1985SE |
| K851386 | Unitek Disposable Impression SyringeEID · Traditional | Unitek Corp. | 04/29/1985SE |
| K812680 | G-C Impression SyringeEID · Traditional | G-C Intl. Corp. | 10/06/1981SE |
| K811582 | The PlacerEID · Traditional | Cavitron Corp. | 07/28/1981SE |
| K781977 | Applicator, Lee ImpressionEID · Traditional | Lee Pharmaceuticals | 12/20/1978SE |
More from Lee Pharmaceuticals
| 510(k) | Device | Decision |
|---|---|---|
| K782080 | Veneer System, Mostique LaminateKLE · Traditional | 01/26/1979SE |
Questions and answers
When was Prisma-Fil Compules cleared by the FDA?
Prisma-Fil Compules (K812277) received a 510(k) decision of Substantially Equivalent on September 8, 1981, 26 days after the submission was received.
What is the product code of K812277?
The FDA product code is EID – Syringe, Restorative And Impression Material, a Class I (low risk) device regulated under 21 CFR 872.4565.