Unitek Disposable Impression Syringe
FDA 510(k) K851386 · Unitek Corp.
510(k) numberK851386
Submission
- Device name
- Unitek Disposable Impression Syringe
- Applicant
- Unitek Corp.
Monrovia, CA, US - Received
- April 9, 1985
- Decision date
- April 29, 1985
- 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 |
| K812680 | G-C Impression SyringeEID · Traditional | G-C Intl. Corp. | 10/06/1981SE |
| 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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| K924645 | Transcend Series 6000 Debonding InstrumentsJEX · Traditional | 11/25/1992SE |
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| K923432 | German Mini DynalockEJF · Traditional | 10/30/1992SE |
| K911271 | Adhesive Precoated BracketsDYH · Traditional | 05/29/1991SE |
| K910288 | Nonstaining AlastiksEJF · Traditional | 03/29/1991SE |
| K890529 | AlastigardEJF · Traditional | 03/09/1989SE |
Questions and answers
When was Unitek Disposable Impression Syringe cleared by the FDA?
Unitek Disposable Impression Syringe (K851386) received a 510(k) decision of Substantially Equivalent on April 29, 1985, 20 days after the submission was received.
What is the product code of K851386?
The FDA product code is EID – Syringe, Restorative And Impression Material, a Class I (low risk) device regulated under 21 CFR 872.4565.