Orthocent: Liquid and Powder
FDA 510(k) K942665 · Dentauraum, Inc.
510(k) numberK942665
Submission
- Device name
- Orthocent: Liquid and Powder
- Applicant
- Dentauraum, Inc.
Newtown, PA, US - Received
- June 6, 1994
- Decision date
- July 22, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K254063 | iCEM Universal PlusEMA · Abbreviated | Kulzer, LLC | 12/19/2025SE |
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| K252808 | GlasIonomer FX-LCEMA · Traditional | Shofu Dental Corporation | 12/09/2025SE |
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| K952870 | Remanium: CS & G-SoftEJH · Traditional | 07/27/1995SE |
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| K952865 | Remanium: 200,CS, 380, and CDEJH · Traditional | 07/26/1995SE |
| K952868 | Dentaurum Jacket Crown & Root PostsEBL · Traditional | 07/19/1995SE |
| K942667 | Dent-O-Cryl Orthodontic AcrylicKMY · Traditional | 02/13/1995SE |
| K942666 | Orthalgenat Impression MaterialELW · Traditional | 08/10/1994SE |
| K936151 | Extraoral HeadgearDZB · Traditional | 08/01/1994SE |
| K942668 | O-Tray Impression TraysEHY · Traditional | 07/22/1994SE |
| K935856 | Dentaurum Space MaintainerDYT · Traditional | 04/28/1994SE |
Questions and answers
When was Orthocent: Liquid and Powder cleared by the FDA?
Orthocent: Liquid and Powder (K942665) received a 510(k) decision of Substantially Equivalent on July 22, 1994, 46 days after the submission was received.
What is the product code of K942665?
The FDA product code is EMA – Cement, Dental, a Class II (moderate risk) device regulated under 21 CFR 872.3275.