Not currently registered with FDA under this name
Pentron Corp.
Wallingford, CT, United States. Named as applicant on 15 dental 510(k) clearances between 1984 and 2002. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 151984–2002
- Markets registered in
- 22 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1980–2026
Registered in 2 markets
Where regulators' registries name Pentron Corp. 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 | Pentron Corp. | 15 clearances | 1984–2002 | Below |
| South Korea | MFDS | Manufacturer | Pentron, LLC. | 2 | 2004–2004 | 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 Pentron Corp. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 1 Aug 2002 | K021457 | FLEX SPAN TEMPORARY CROWN & BRIDGE MATERIAL | EBG Resin Temporary Crown and Bridge |
| 11 Feb 1988 | K874189 | DUAL-CURE RADIOPAQUE | EBF Resin Tooth Shade Material |
| 19 Jan 1988 | K874275 | OPTEC SUPPLEMENTARY KIT | EBF Resin Tooth Shade Material |
| 12 Jan 1988 | K874162 | OPTEC STAIN CHARACTERIZATION AND MODIFICATION KIT | EBF Resin Tooth Shade Material |
| 16 Nov 1987 | K873683 | CODE #23 R SYSTEM (DENTIN ADHESIVE MATERIAL) | EBF Resin Tooth Shade Material |
| 27 Oct 1987 | K873878 | #24L SYSTEM | EBF Resin Tooth Shade Material |
| 24 Nov 1986 | K864404 | PENTRON HIGH STRENGTH PORCELAIN | EIH Porcelain Powder |
| 4 Mar 1986 | K854803 | CHAMELEON BONDING KIT | EBF Resin Tooth Shade Material |
| 3 Dec 1984 | K844057 | C-22 PIT & FISSURE SEALANT | EBC Pit and Fissure Sealant and Conditioner |
| 22 May 1984 | K841458 | NUMBER 20 R/L SYSTEM | KLE Resin Tooth Bonding Agent |
| 22 May 1984 | K841457 | NUMBER 21 R/R SYSTEM | KLE Resin Tooth Bonding Agent |
| 22 May 1984 | K841269 | C-19 | EBF Resin Tooth Shade Material |
| 22 May 1984 | K841268 | C-17 | EBF Resin Tooth Shade Material |
| 30 Apr 1984 | K841267 | C-18 | EBF Resin Tooth Shade Material |
| 13 Apr 1984 | K840727 | PENTRA-FIL II | EBF Resin Tooth Shade Material |
Some of these clearances are listed with FDA today by another company: Sybron Dental Specialties (2).
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.