Mdt/Castle Purus Dental Unit
FDA 510(k) K914697 · Mdt Corp., Inc.
510(k) numberK914697
Submission
- Device name
- Mdt/Castle Purus Dental Unit
- Applicant
- Mdt Corp., Inc.
Rochester, NY, US - Received
- October 18, 1991
- Decision date
- November 13, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K932094 | Bovie Ultrasonic Surgical AspiratorLFL · Traditional | 07/21/1993SE |
| K931169 | MDT Dental ChairKLC · Traditional | 05/20/1993SE |
| K920930 | Mdt/Castle 10/90 Dual Load StationFLF · Traditional | 03/31/1993SE |
| K922212 | MDT Castle Biosign Test PackFRC · Traditional | 08/10/1992SE |
Questions and answers
When was Mdt/Castle Purus Dental Unit cleared by the FDA?
Mdt/Castle Purus Dental Unit (K914697) received a 510(k) decision of Substantially Equivalent on November 13, 1991, 26 days after the submission was received.
What is the product code of K914697?
The FDA product code is EIA – Unit, Operative Dental, a Class I (low risk) device regulated under 21 CFR 872.6640.