Manufacturer registered with FDA
HealthDentl LLC
Plainfield, IL, United States. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What HealthDentl LLC currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Maker | Hema BenzHema Glu | 2016 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
HealthDentl LLC lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Health-Dent Intl., Inc. (2).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 27 Sep 1995 | K953405 | HEMA-BENZ | Health-Dent Intl., Inc. | KLE Resin Tooth Bonding Agent |
| 12 May 1995 | K951220 | HEMA-GLU | Health-Dent Intl., Inc. | KLE Resin Tooth Bonding Agent |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| HEALTHDENT'L, LLCFDA reg. 3013411964 | Plainfield, IL, United States | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10053526). 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.