Not currently registered with FDA under this name
Confi-Dental Products Co.
Louisville, CO, United States. Named as applicant on 31 dental 510(k) clearances between 1989 and 2003. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 311989–2003
- Markets registered in
- 32 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1980–2026
Registered in 3 markets
Where regulators' registries name Confi-Dental Products Co. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Confi-Dental Products Co. | 31 clearances | 1989–2003 | Below |
| Brazil | ANVISA | Manufacturer | CONFI-DENTAL PRODUCTS CO. | 1 | 2009–2009 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | CONFI-DENTAL PRODUCTS CO., | 1 | 2006–2006 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
510(k) clearances
Clearances on which FDA names Confi-Dental Products Co. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 9 Jun 2003 | K030807 | CARIES INDICATOR | LFC Caries Detection Device |
| 9 May 2003 | K030743 | ETCHANT 40% | KLE Resin Tooth Bonding Agent |
| 28 Mar 1996 | K955329 | RESILIENCE M5 PROTECTION PLUS | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 28 Mar 1996 | K955328 | CONFI-BOND | KLE Resin Tooth Bonding Agent |
| 8 Mar 1996 | K954988 | CRYSTALLESSENCE | EBF Resin Tooth Shade Material |
| 8 Sep 1995 | K952930 | DENTRAY II PLUS TRAY ADHESIVE | ELW Impression Material |
| 26 Jan 1995 | K946307 | CYRSTALLINE L3 MULTI-USE HYBRID COMPOSITE | EBF Resin Tooth Shade Material |
| 29 Apr 1994 | K940546 | GRANITEC IONOMER RESIN CEMENT | EMA Dental Cement |
| 4 Feb 1994 | K936070 | TREND SET 2 PLUS | ELW Impression Material |
| 21 Jan 1994 | K935714 | CRYSTALLINE L3 MULTI-USE HYBRID COMPOSITE | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 6 Jan 1994 | K933199 | CRYSTALLINE 'FLUORITE' CORE BUILD-UP MATERIAL | EMA Dental Cement |
| 22 Jul 1993 | K932002 | BARITONE C2, MODIFICATION | EBC Pit and Fissure Sealant and Conditioner |
| 22 Jul 1993 | K931857 | SUPPLEMENTAL FORMULA TO BARITONE L3 SEALANT | EBC Pit and Fissure Sealant and Conditioner |
| 8 Jul 1993 | K925359 | RESILIENCE ORTHODONTIC BRACKET ADHES W/BOND RESINS | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 19 May 1993 | K920533 | DENTIN BONDING AGENT | EBF Resin Tooth Shade Material |
| 8 Apr 1993 | K920843 | TOOTH CONDITIONER | KZP Cement Dissolving Solution |
| 26 Mar 1992 | K920534 | PORCELAIN PRIMER | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 26 Mar 1992 | K914317 | ORTHODONTIC BRACKET ADHESIVE RESIN MATERIAL | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 20 Mar 1992 | K914318 | GLASS IONOMER CEMENT | EMA Dental Cement |
| 9 Mar 1992 | K914325 | ROOT CANAL FILLING CEMENT | KIF Root Canal Filling Resin |
| 27 Dec 1991 | K914324 | CAVITY VARNISH PRODUCT | EMA Dental Cement |
| 23 Oct 1991 | K914322 | BARITONE C2 & BARITONE L3 | EBC Pit and Fissure Sealant and Conditioner |
| 23 Oct 1991 | K914319 | PIT AND FISSURE SEALANT PRODUCTS | EBC Pit and Fissure Sealant and Conditioner |
| 28 Aug 1990 | K902817 | SURGI PAK NE AND COCOMENT EUGENAL FREE PASTE SYST | EMA Dental Cement |
| 10 Jul 1990 | K902635 | MODIFIED GRANITEC P2 & G2 DENTAL CEMENTS | EMA Dental Cement |
| 13 Mar 1990 | K896950 | CORE BUILD UP COMPOSITE | EBF Resin Tooth Shade Material |
| 22 Feb 1990 | K896649 | GRANITEC Z2, ZINC PHOSPHATE CEMENT | EMA Dental Cement |
| 6 Feb 1990 | K894953 | GRANITEC P2 AND GRANITEC G2 DENTAL CEMENTS | EMA Dental Cement |
| 27 Oct 1989 | K894890 | CRYSTALLINE C2 AND CRYSTALLINE L3 | EBF Resin Tooth Shade Material |
| 19 May 1989 | K891463 | ADHERENCE M5 MULTI-CURE COMPOSITE CEMENT SYSTEM | EBF Resin Tooth Shade Material |
| 18 May 1989 | K891464 | RESILIENCE C2, RESILIENCE L3 & RESILIENCE P4 | DYH Resin Bracket and Tooth Conditioner Adhesive |
Some of these clearances are listed with FDA today by another company: Temrex Corp. (2), Rmo, Inc. (1), Young Innovations 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.