Stardental Axcs Sterile Water System
FDA 510(k) K990844 · Dentalez Group
510(k) numberK990844
Submission
- Device name
- Stardental Axcs Sterile Water System
- Applicant
- Dentalez Group
Lancaster, PA, US - Received
- March 15, 1999
- Decision date
- May 28, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K982593 | Lube Free Autochuck Turbine with Vortex Air Seal for Use with Star Dental 430 Series…EFB · Traditional | 10/22/1998SE |
| K960719 | Star Dental 430 Series High Speed HandpieceEFA · Traditional | 03/28/1996SE |
| K960507 | Star Dental Pushbutton Autochuck Replacement Turbine for Midwest HandpiecesEFA · Traditional | 03/28/1996SE |
| K960260 | Star Titan Series Motors & AttachmentsEFA · Traditional | 03/28/1996SE |
| K925567 | E 4000 Dental Operating ChairKLC · Traditional | 03/10/1994SE |
| K931093 | Quick-Connect 360 Swivel Tip Autoclavable SyringeEIA · Traditional | 01/21/1994SE |
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Questions and answers
When was Stardental Axcs Sterile Water System cleared by the FDA?
Stardental Axcs Sterile Water System (K990844) received a 510(k) decision of Substantially Equivalent on May 28, 1999, 74 days after the submission was received.
What is the product code of K990844?
The FDA product code is EIA – Unit, Operative Dental, a Class I (low risk) device regulated under 21 CFR 872.6640.