Coltene, Inc.
Medical device manufacturer in New York, NY.
15510(k) clearances
0PMA approvals
0recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K041098 | Cool Temp NaturalEBG · Traditional | 05/13/2004SE |
| K022224 | Cool Bond Light Cured Bracket Adhesive SystemDYH · Traditional | 09/18/2002SE |
| K902392 | Coltosol Temporary Endodontic Filling MaterialEMA · Traditional | 08/28/1990SE |
| K882800 | Coltene President Jet Regular BodyELW · Traditional | 09/23/1988SE |
| K873671 | Coltene President Jet Impression Materials SystemEKS · Traditional | 10/27/1987SE |
| K870266 | Coltene Brilliant D.I. Direct Inlay SystemEBF · Traditional | 02/27/1987SE |
| K870047 | Coltene RapidELW · Traditional | 01/29/1987SE |
| K863998 | Coltene Jet-MixerEID · Traditional | 10/30/1986SE |
| K850036 | Coltene PreciseELW · Traditional | 02/08/1985SE |
| K840297 | Coltene Oralloy MagicapsEJJ · Traditional | 03/16/1984SE |
| K811767 | Coltene President Impression MaterialsELW · Traditional | 07/15/1981SE |
| K811667 | Coltene Pressure Spot IndicatorELW · Traditional | 07/15/1981SE |
| K811666 | Coltene Coltex/ColtoflaxELW · Traditional | 07/15/1981SE |
| K811363 | Coltene DRS Dental Restorative SystemEBF · Traditional | 06/16/1981SE |
| K810907 | Coltene OrallyEJJ · Traditional | 04/23/1981SE |