The Placer
FDA 510(k) K811582 · Cavitron Corp.
510(k) numberK811582
Submission
- Device name
- The Placer
- Applicant
- Cavitron Corp.
Mchenry, IL, US - Received
- June 5, 1981
- Decision date
- July 28, 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 |
| 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 |
| K781977 | Applicator, Lee ImpressionEID · Traditional | Lee Pharmaceuticals | 12/20/1978SE |
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| K800869 | Model PM-20(N)(R)CO2 Patient Monitor/AlaCCK · Traditional | 05/28/1980SE |
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| K791585 | Model G-61 Ultrasonic Dental UnitELC · Traditional | 09/19/1979SE |
| K791277 | Model 6500 Extraction Irrigation SysHDQ · Traditional | 08/22/1979SE |
| K782054 | Laser, CO2 SurgicalHHR · Traditional | 01/17/1979SE |
| K782065 | Laser, PhotocoagulationHQF · Traditional | 12/28/1978SE |
Questions and answers
When was The Placer cleared by the FDA?
The Placer (K811582) received a 510(k) decision of Substantially Equivalent on July 28, 1981, 53 days after the submission was received.
What is the product code of K811582?
The FDA product code is EID – Syringe, Restorative And Impression Material, a Class I (low risk) device regulated under 21 CFR 872.4565.