G-C Impression Syringe
FDA 510(k) K812680 · G-C Intl. Corp.
510(k) numberK812680
Submission
- Device name
- G-C Impression Syringe
- Applicant
- G-C Intl. Corp.
Mchenry, IL, US - Received
- September 22, 1981
- Decision date
- October 6, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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|---|---|---|---|
| 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 |
| K812277 | Prisma-Fil CompulesEID · Traditional | Caulk Co., Div. Dentsply | 09/08/1981SE |
| K811582 | The PlacerEID · Traditional | Cavitron Corp. | 07/28/1981SE |
| K781977 | Applicator, Lee ImpressionEID · Traditional | Lee Pharmaceuticals | 12/20/1978SE |
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|---|---|---|
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| K901999 | Fuji Lining Cement Light CureEJK · Traditional | 07/31/1990SE |
| K902531 | Exaphase, Single Phase Impression MaterialEGW · Traditional | 07/13/1990SE |
| K896883 | GC Cervical CementEMA · Traditional | 07/06/1990SE |
| K895976 | Tooth Shade ResinEBF · Traditional | 12/22/1989SE |
| K892806 | Tuf-CoatELL · Traditional | 07/14/1989SE |
| K890830 | Denture ResinEBI · Traditional | 05/01/1989SE |
| K890829 | Unifast LCEBG · Traditional | 04/17/1989SE |
| K883770 | Resubmitted Ema Dentin CementEMA · Traditional | 11/30/1988SE |
Questions and answers
When was G-C Impression Syringe cleared by the FDA?
G-C Impression Syringe (K812680) received a 510(k) decision of Substantially Equivalent on October 6, 1981, 14 days after the submission was received.
What is the product code of K812680?
The FDA product code is EID – Syringe, Restorative And Impression Material, a Class I (low risk) device regulated under 21 CFR 872.4565.