Dental Office Environment Control Unit
FDA 510(k) K780701 · Laminaire Corp.
510(k) numberK780701
Submission
- Device name
- Dental Office Environment Control Unit
- Applicant
- Laminaire Corp.
Mchenry, IL, US - Received
- April 26, 1978
- Decision date
- May 16, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EHZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K973248 | Imtec Bone Collector SystemEHZ · Traditional | Imtec Corp. | 11/19/1997SE |
| K941164 | Tap Express EjectorEHZ · Traditional | Tap Express, Inc. | 05/18/1994SE |
| K911072 | Super Evacretractor, Disposable Oral EvacuatorEHZ · Traditional | A & F Products | 05/15/1991SE |
| K903718 | Oroscope Model Number COS-100EHZ · Traditional | Cygnus Instruments, Inc. | 11/09/1990SE |
| K892882 | Dental Sani-Sleeve Sterile 100MM X 2200MM #1102EHZ · Traditional | Nieusma R & D, Inc. | 06/23/1989SE |
| K892881 | Dental Sani-Sleeve Sterile 60MM X 1650MM #1101EHZ · Traditional | Nieusma R & D, Inc. | 06/23/1989SE |
| K880754 | Dri-Clave Liquid KleenzallEHZ · Traditional | Columbus Dental Mfg. Co. | 05/12/1988SE |
| K873545 | Portable Field Dental Operating & Treatment UnitEHZ · Traditional | Commercial Products & Engineering Co. | 11/20/1987SE |
| K874401 | Titanium Suction TipEHZ · Traditional | Implant Innovations International, Inc. | 11/12/1987SE |
| K864621 | Vac - Rite Right Angle Aspirator Tube & HolderEHZ · Traditional | Seldoren , Ltd. | 02/13/1987SE |
Questions and answers
When was Dental Office Environment Control Unit cleared by the FDA?
Dental Office Environment Control Unit (K780701) received a 510(k) decision of Substantially Equivalent on May 16, 1978, 20 days after the submission was received.
What is the product code of K780701?
The FDA product code is EHZ – Evacuator, Oral Cavity, a Class I (low risk) device regulated under 21 CFR 872.6640.