Coe Laboratories, Inc.
Medical device manufacturer in Alsip, IL.
20510(k) clearances
0PMA approvals
0recalls
Device types
- ELW Material, Impression 7
- EBI Resin, Denture, Relining, Repairing, Rebasing 2
- EBF Material, Tooth Shade, Resin 2
- ESH Polymer, Ent Synthetic-Pife, Silicon… 1
- LDG Kit, Earmold, Impression 1
- EJK Liner, Cavity, Calcium Hydroxide 1
- EBG Crown And Bridge, Temporary, Resin 1
- LGX Table, Examination, Medical, Powered 1
- EBZ Activator, Ultraviolet, For Polymerization 1
- EMA Cement, Dental 1
- KLE Agent, Tooth Bonding, Resin 1
- EBC Sealant, Pit And Fissure, And Conditioner 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K903292 | Accuflex/Accumix Vinyl Poly Impression MaterialsELW · Traditional | 10/19/1990SE |
| K894282 | First Impression TMELW · Traditional | 12/22/1989SE |
| K894281 | First Impression with ChlorhexidineELW · Traditional | 09/26/1989SE |
| K891140 | Occlu-Seal(Tm) Visible Light-Cured Fissure SealantEBC · Traditional | 05/01/1989SE |
| K885010 | Tripton(Tm) Visible Light-Cured Univ. BondingKLE · Traditional | 02/13/1989SE |
| K881422 | Coe Pak Auto Mix, Regular or Hard SetEMA · Traditional | 10/31/1988SE |
| K881091 | Omnisil, Vinyl Polysiloxane Impression MaterialELW · Traditional | 06/28/1988SE |
| K863882 | Opalux Visible Light Cured Anterior CompositeEBF · Traditional | 11/18/1986SE |
| K842877 | Absolute Vinyl Polysiloxane ImpressELW · Traditional | 03/11/1985SE |
| K844325 | Coe-Lite Polymerization UnitEBZ · Traditional | 12/11/1984SE |
| K844326 | Occlusin Light Cured Visible Radiopaque CompositeEBF · Traditional | 12/03/1984SE |
| K830294 | Medical Exam TableLGX · Traditional | 01/11/1984SE |
| K833261 | Interim Temp. Crown & Bridge ResinEBG · Traditional | 01/03/1984SE |
| K831575 | Nu-Cap Calcium Hydrox. Pulp CappingEJK · Traditional | 06/30/1983SE |
| K820673 | Self-Curing Hard Denture LinerEBI · Traditional | 04/09/1982SE |
| K792428 | Coe-SilLDG · Traditional | 01/23/1980SE |
| K792427 | Perma-Cryl 20EBI · Traditional | 12/13/1979SE |
| K771615 | Audi-Sil Earmold MaterialESH · Traditional | 08/30/1977SE |
| K760226 | Paste, Accoe ImpressionELW · Traditional | 07/21/1976SE |
| K760225 | Putty, AccoeELW · Traditional | 07/21/1976SE |