W&H 795 Top Air Turbine Single Spray
FDA 510(k) K944715 · A-Dec, Inc.
510(k) numberK944715
Submission
- Device name
- W&H 795 Top Air Turbine Single Spray
- Applicant
- A-Dec, Inc.
Newberg, OR, US - Received
- September 23, 1994
- Decision date
- June 2, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K220179 | High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air MotorsEFB · Traditional | Foshan Coxo Medical Instrument Co., Ltd. | 09/22/2023SE |
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| K213932 | A-dec 300, A-dec 500EIA · Traditional | 03/02/2022SE |
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| K082716 | A-Dec/W&H Alegra Air-Driven Highspeed Handpiece, Model TE-97, TE-98, A-Dec/W&H Alegra…EFB · Abbreviated | 01/15/2009SE |
| K082827 | A-Dec/W&H Profin Reciprocating Contra-Angle Handpiece AttachmentEFB · Abbreviated | 01/07/2009SE |
| K082985 | A-Dec 334/335 Delivery SystemEIA · Traditional | 12/17/2008SE |
| K070663 | A-Dec/W&H Synea Air-Driven Highspeed Handpiece, Model TA-98, TA-97, A-Dec/W&H Synea…EFB · Abbreviated | 07/05/2007SE |
| K051657 | A-Dec Self-Contained Water SystemEIA · Traditional | 08/30/2005SE |
| K032757 | A-Dec Self-Contained Water System, Model 0.7 Liter Bottle & 2 Liter BottleEIA · Traditional | 12/10/2003SE |
Questions and answers
When was W&H 795 Top Air Turbine Single Spray cleared by the FDA?
W&H 795 Top Air Turbine Single Spray (K944715) received a 510(k) decision of Substantially Equivalent on June 2, 1995, 252 days after the submission was received.
What is the product code of K944715?
The FDA product code is EFB – Handpiece, Air-Powered, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.