Company ยท US
Dentsply Interntional
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2009. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KIF | Resin, Root Canal Filling | 2 |
| LYC | Bone Grafting Material, Synthetic | 2 |
| NJM | Bracket, Ceramic, Orthodontic | 2 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 1 |
| DYW | Bracket, Plastic, Orthodontic | 1 |
| EBG | Crown And Bridge, Temporary, Resin | 1 |
| EKX | Handpiece, Direct Drive, Ac-Powered | 1 |
| ELC | Scaler, Ultrasonic | 1 |
| EMA | Cement, Dental | 1 |
| NXC | Aligner, Sequential | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 2, 2009 | K092614 | X-SMART EASY Dentsply Interntional | EKX |
| Jul 24, 2009 | K092030 | ELATION MB METAL REINFORCED PLASTIC BRACKET Dentsply Interntional | DYW |
| Mar 20, 2009 | K090454 | ALLURE MB CERAMIC BRACKETS Dentsply Interntional | NJM |
| Jan 29, 2009 | K082973 | STER-MATE STERILE LAVAGE KIT Dentsply Interntional | ELC |
| Nov 7, 2008 | K082974 | MYSTIQUE MB CERAMIC BRACKETS Dentsply Interntional | NJM |
| May 22, 2008 | K081291 | PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION Dentsply Interntional | DYH |
| Apr 18, 2008 | K080311 | MODIFIED TEMPRX ESTHETIC PROVISIONAL SYSTEM Dentsply Interntional | EBG |
| Apr 11, 2008 | K080246 | COMPOSITE ALIGNER BUTTON Dentsply Interntional | NXC |
| Mar 26, 2008 | K080203 | MTA ROOT CANAL SEALER Dentsply Interntional | KIF |
| Jan 23, 2008 | K073173 | SELF-ADHESIVE RESIN CEMENT Dentsply Interntional | EMA |
| Jan 7, 2008 | K073218 | MTA ADVANCED MATERIAL Dentsply Interntional | KIF |
| Sep 4, 2007 | K071817 | OSTEOGRAF/N-300 Dentsply Interntional | LYC |
| Aug 3, 2007 | K072058 | MODIFICATION TO: OSTEOGRAF/N-700 Dentsply Interntional | LYC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||