Not currently registered with FDA under this name
Dentsply Interntional
York, PA, United States. Named as applicant on 13 dental 510(k) clearances between 2007 and 2009. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 132007–2009
- Markets registered in
- 1United States
- Establishments
- 0—
510(k) clearances per year, 2000–2026
510(k) clearances
Clearances on which FDA names Dentsply Interntional as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 2 Dec 2009 | K092614 | X-SMART EASY | EKX Ac-Powered Direct Drive Handpiece |
| 24 Jul 2009 | K092030 | ELATION MB METAL REINFORCED PLASTIC BRACKET | DYW Orthodontic Plastic Bracket |
| 20 Mar 2009 | K090454 | ALLURE MB CERAMIC BRACKETS | NJM Orthodontic Ceramic Bracket |
| 29 Jan 2009 | K082973 | STER-MATE STERILE LAVAGE KIT | ELC Ultrasonic Scaler |
| 7 Nov 2008 | K082974 | MYSTIQUE MB CERAMIC BRACKETS | NJM Orthodontic Ceramic Bracket |
| 22 May 2008 | K081291 | PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 18 Apr 2008 | K080311 | MODIFIED TEMPRX ESTHETIC PROVISIONAL SYSTEM | EBG Resin Temporary Crown and Bridge |
| 11 Apr 2008 | K080246 | COMPOSITE ALIGNER BUTTON | NXC Sequential Aligner |
| 26 Mar 2008 | K080203 | MTA ROOT CANAL SEALER | KIF Root Canal Filling Resin |
| 23 Jan 2008 | K073173 | SELF-ADHESIVE RESIN CEMENT | EMA Dental Cement |
| 7 Jan 2008 | K073218 | MTA ADVANCED MATERIAL | KIF Root Canal Filling Resin |
| 4 Sep 2007 | K071817 | OSTEOGRAF/N-300 | LYC Synthetic Bone Grafting Material |
| 3 Aug 2007 | K072058 | MODIFICATION TO: OSTEOGRAF/N-700 | LYC Synthetic Bone Grafting Material |
Some of these clearances are listed with FDA today by another company: Dentsply Sirona, Inc. (1).
Sources
FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.