Manufacturer registered with FDA
Beutlich Pharmaceuticals, LLC
Bunnell, FL, United States. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 3
- 510(k) clearances
- 0as applicant
- Markets registered in
- 22 registrations outside the US
- Establishments
- 1United States
Registered in 2 markets
Where regulators' registries name Beutlich Pharmaceuticals, LLC as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Beutlich Pharmaceuticals, LLC | 2 device types | — | Below |
| Canada | Health Canada | Registration holder | BEUTLICH PHARMACEUTICALS, LLC | 2 | 1999–2004 | 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
Devices listed with FDA
What Beutlich Pharmaceuticals, 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 | HurriSeal | 2007 |
| Plaque Disclosing AgentQJC · Class 1 | — | Maker | HurriView ® Plaque Indicating Snap-n-Go SwabsHurriView II ® Two-Tone Plaque Indicating Snap-n-Go Swabs | 2019 |
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
Beutlich Pharmaceuticals, 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: Cheng & Assoc., Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 23 Mar 1998 | K973002 | HURRISEAL DENTIN DESENSITIZER | Cheng & Assoc., Inc. | KLE Resin Tooth Bonding Agent |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| BEUTLICH PHARMACEUTICALS, LLCFDA reg. 1413399 | Bunnell, FL, United States | Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9023834). 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.