Applicator, Lee Impression
FDA 510(k) K781977 · Lee Pharmaceuticals
510(k) numberK781977
Submission
- Device name
- Applicator, Lee Impression
- Applicant
- Lee Pharmaceuticals
Mchenry, IL, US - Received
- November 27, 1978
- Decision date
- December 20, 1978
- 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 |
| K812277 | Prisma-Fil CompulesEID · Traditional | Caulk Co., Div. Dentsply | 09/08/1981SE |
| K811582 | The PlacerEID · Traditional | Cavitron Corp. | 07/28/1981SE |
More from Cavitron Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K924378 | Restobond 4KLE · Traditional | 03/31/1993SE |
| K912256 | Precise(R) Beta Quartz Glass-Ceramic InsertKLE · Traditional | 07/24/1991SE |
| K900809 | Lee-Fischer Ceramic Reinforced Plastic BracketsDYW · Traditional | 06/28/1990SE |
| K894315 | Restobond 3/DENTIN-ENAMEL Bonding AgentKLE · Traditional | 10/31/1989SE |
| K881903 | Prosthodent VLEBF · Traditional | 07/01/1988SE |
| K873123 | Lee Composite Inlay SystemEBF · Traditional | 01/20/1988SE |
| K863157 | Restodent PosteriorEBF · Traditional | 09/25/1986SE |
| K854882 | Protec/Visible Light-Cured Sealant/Dental RestoratEBC · Traditional | 01/30/1986SE |
| K844134 | Cleanse N Bond IIDYH · Traditional | 01/04/1985SE |
| K844133 | Cleanse N Bond IDYH · Traditional | 01/04/1985SE |
Questions and answers
When was Applicator, Lee Impression cleared by the FDA?
Applicator, Lee Impression (K781977) received a 510(k) decision of Substantially Equivalent on December 20, 1978, 23 days after the submission was received.
What is the product code of K781977?
The FDA product code is EID – Syringe, Restorative And Impression Material, a Class I (low risk) device regulated under 21 CFR 872.4565.