Aeroetcher
FDA 510(k) K973679 · Parkell, Inc.
510(k) numberK973679
Submission
- Device name
- Aeroetcher
- Applicant
- Parkell, Inc.
Farmingdale, NY, US - Received
- September 26, 1997
- Decision date
- March 10, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code KOJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251425 | turbodent touchKOJ · Traditional | Mectron S.P.A. | 05/09/2025SE |
| K063236 | Beta-PowderKOJ · Traditional | Brainbase Corporation | 02/16/2007SE |
| K042872 | Rondoflex Plus 360KOJ · Special | Kavo America Corporation | 11/23/2004SE |
| K033675 | Prosmile Air Polisher and Prophylaxis PowderKOJ · Traditional | Sirona Dental Systems GmbH | 01/15/2004SE |
| K033215 | PrepairKOJ · Traditional | Danville Materials, Inc. | 01/09/2004SE |
| K024105 | Velopex Aquacut Fluid Abrasion UnitKOJ · Traditional | Velopex International, Inc. | 10/09/2003SE |
| K030292 | Groman PrepmasterKOJ · Traditional | Groman, Inc. | 04/15/2003SE |
| K021450 | Clinpro Prophy PowderKOJ · Traditional | 3M Espe AG Dental Products | 08/01/2002SE |
| K014188 | New Prophy PowderKOJ · Traditional | Dentsply Intl. | 03/15/2002SE |
| K014252 | JetstreamKOJ · Traditional | Deldent , Ltd. | 02/19/2002SE |
More from Deldent , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K243254 | Parkell Pit and Fissure SealantEBC · Abbreviated | 08/08/2025SE |
| K210259 | Parkell Self-Adhesive CementEMA · Traditional | 01/20/2022SE |
| K191103 | Parkell Desensitizer GelEJK · Traditional | 11/22/2019SE |
| K190930 | SmarTemp X1EBG · Traditional | 09/05/2019SE |
| K182296 | HyperFil-LVEBF · Traditional | 12/14/2018SE |
| K172176 | Parkell Universal AdhesiveKLE · Traditional | 11/21/2017SE |
| K151518 | Brush&Bond PlusKLE · Traditional | 09/18/2015SE |
| K142848 | Eazy PrimerKLE · Traditional | 02/24/2015SE |
| K132115 | Absolute Dentin 2EBF · Traditional | 06/25/2014SE |
| K113839 | Retract Gingival Retraction/Hemostatic PasteMVL · Traditional | 04/12/2012SE |
Questions and answers
When was Aeroetcher cleared by the FDA?
Aeroetcher (K973679) received a 510(k) decision of Substantially Equivalent on March 10, 1998, 165 days after the submission was received.
What is the product code of K973679?
The FDA product code is KOJ – Airbrush, a Class II (moderate risk) device regulated under 21 CFR 872.6080.