Not currently registered with FDA under this name
Health-Dent Intl., Inc.
Oswego, IL, United States. Named as applicant on 8 dental 510(k) clearances between 1995 and 1997. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 81995–1997
- Markets registered in
- 1United States
- Establishments
- 0—
510(k) clearances per year, 1990–2026
510(k) clearances
Clearances on which FDA names Health-Dent Intl., Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 17 Dec 1997 | K972198 | DENT-TEMP ACRYLIC | EBG Resin Temporary Crown and Bridge |
| 27 Sep 1995 | K953405 | HEMA-BENZ | KLE Resin Tooth Bonding Agent |
| 12 May 1995 | K951220 | HEMA-GLU | KLE Resin Tooth Bonding Agent |
| 27 Apr 1995 | K951381 | VILA | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 27 Apr 1995 | K951380 | VILA PC | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 20 Apr 1995 | K951235 | GIROC | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 18 Apr 1995 | K951236 | PRO-LOCK | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 10 Apr 1995 | K951237 | ALGI-BAND | ELW Impression Material |
Some of these clearances are listed with FDA today by another company: HealthDentl LLC (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.