Dental Equipment Protection Devices
FDA 510(k) K891216 · Pro-Safe Professional Linens, Inc.
510(k) numberK891216
Submission
- Device name
- Dental Equipment Protection Devices
- Applicant
- Pro-Safe Professional Linens, Inc.
Grand Junction, CO, US - Received
- March 7, 1989
- Decision date
- June 2, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EAZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K072309 | Microlux/BluEAZ · Traditional | Addent, Inc. | 11/19/2007SE |
| K041614 | Microlux DLEAZ · Traditional | Addent, Inc. | 04/04/2005SE |
| K033033 | Vizilite-Blue Oral Exam KitEAZ · Traditional | Trylon Corp. | 11/22/2004SE |
| K003995 | Speculite/OralliteEAZ · Traditional | Trylon Corp. | 03/16/2001SE |
| K926081 | Dental LightEAZ · Traditional | Mdt Corp., Inc. | 01/26/1994SE |
| K935390 | Sirolux FantasticEAZ · Traditional | Pelton & Crane Co. | 12/10/1993SE |
| K925629 | Accessory to Improved Dental Operating LightEAZ · Traditional | Den-Tal-Ez Mfg Co., Inc. | 11/23/1993SE |
| K923462 | DelightEAZ · Traditional | Planmeca USA, Inc. | 12/21/1992SE |
| K912997 | Miniflex and Personal UnitEAZ · Traditional | Dabi-Atlante America Corp. | 10/30/1991SE |
| K912142 | Micronaire Iso-Hood Max 5UVEAZ · Traditional | Micronaire Corp. | 10/30/1991SE |
More from Micronaire Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K891210 | Pocketed Wraps #3009 A,B,CKCT · Traditional | 10/13/1989SE |
| K891215 | Fast Wrap #M 101KCT · Traditional | 04/14/1989SE |
| K891214 | Dental Surgical Wrap #3007 A,B,CKCT · Traditional | 04/14/1989SE |
| K891213 | Surgical Instrument Pouch #M102KCT · Traditional | 04/14/1989SE |
| K891212 | Aprons, Scrubs Slacks & Tops, Patient DrapeFXO · Traditional | 04/14/1989SE |
| K891211 | Surgical Gown #2001FYA · Traditional | 04/14/1989SE |
Questions and answers
When was Dental Equipment Protection Devices cleared by the FDA?
Dental Equipment Protection Devices (K891216) received a 510(k) decision of Substantially Equivalent on June 2, 1989, 87 days after the submission was received.
What is the product code of K891216?
The FDA product code is EAZ – Light, Operating, Dental, a Class I (low risk) device regulated under 21 CFR 872.4630.