Dental Sani-Sleeve Sterile 100MM X 2200MM #1102
FDA 510(k) K892882 · Nieusma R & D, Inc.
510(k) numberK892882
Submission
- Device name
- Dental Sani-Sleeve Sterile 100MM X 2200MM #1102
- Applicant
- Nieusma R & D, Inc.
Warren, MI, US - Received
- April 6, 1989
- Decision date
- June 23, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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|---|---|---|---|
| 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 |
| 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 |
| K863769 | Evacuator TipsEHZ · Traditional | The Medical Group, Inc. | 10/30/1986SE |
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Questions and answers
When was Dental Sani-Sleeve Sterile 100MM X 2200MM #1102 cleared by the FDA?
Dental Sani-Sleeve Sterile 100MM X 2200MM #1102 (K892882) received a 510(k) decision of Substantially Equivalent on June 23, 1989, 78 days after the submission was received.
What is the product code of K892882?
The FDA product code is EHZ – Evacuator, Oral Cavity, a Class I (low risk) device regulated under 21 CFR 872.6640.