Registered with FDA
Exacta Dental Products, Inc.
CLINTON TOWNSHIP, MI, United States. Lists 3 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 3
- Brands and models
- 3
- 510(k) clearances
- 12006–2006
- Markets registered in
- 1United States
- Establishments
- 1United States
510(k) clearances per year, 2000–2026
Devices listed with FDA
What Exacta Dental Products, Inc. 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 Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Lister | EXACTA Temp Xtra | 2012 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Lister | EXACTA Mixing Tips | 2012 |
| Impression MaterialELW · Class 2 | Impression materials | Lister | FRESH Bold Impression Material | 2009 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Exacta Dental Products, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 13 Jan 2006 | K053427 | FRESH, DENTAL IMPRESSION MATERIAL | ELW Impression Material |
Some of these clearances are listed with FDA today by another company: Laxmi Dental Limited (1).
Also lists devices cleared under other names
Exacta Dental Products, Inc. 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: Exacta Dental Direct, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 17 Jun 2011 | K102917 | FIXTEMP C&B | Exacta Dental Direct, Inc. | EBG Resin Temporary Crown and Bridge |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| EXACTA DENTAL PRODUCTS, INC.FDA reg. 1836392 | CLINTON TOWNSHIP, MI, United States | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9043538). 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.