Manufacturer registered with FDA
Garreco, LLC.
Heber Springs, AR, United States. Lists 4 dental device types with FDA across 1 registered establishment.
- Device types listed
- 4
- Brands and models
- 11
- 510(k) clearances
- 0as applicant
- Markets registered in
- 219 registrations outside the US
- Establishments
- 1United States
Registered in 2 markets
Where regulators' registries name Garreco, 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 | Garreco, LLC. | 4 device types | — | Below |
| Canada | Health Canada | Registration holder | GARRECO, LLC | 19 | 2017–2017 | 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 Garreco, 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 |
|---|---|---|---|---|
| Intraoral Dental WaxEGD · Class 1 | — | Maker | Garreco Base Plate Wax Sheets All SeasonGarreco Base Plate Wax Sheets Medium HardGarreco Base Plate Wax Sheets Medium SoftPEMACO 2000 INTRAORAL DENTAL WAXPEMACO 3000 INTRAORAL DENTAL WAXPEMACO BITE BLOCK RODS-MEDIUM SOFT & MEDIUM HARDPEMACO BITE WAX SHEETSPEMACO ECONOMY BASE PLATE WAX-MEDIUM HARDPEMACO ECONOMY BASE PLATE WAX-MEDIUM SOFTPEMACO INTRAORAL DENTAL WAX | 2018 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Lister | — | 2016 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Lister | — | 2013 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Lister | Garreco | 2013 |
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
Garreco, 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: Pemaco, Inc. (7), St. George Technology, Inc. (3).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 10 Feb 2000 | K992176 | EXCEL ULTRA-HI FORMULA HEAT-CURED DENTURE BASE MATERIAL | St. George Technology, Inc. | EBI Rebasing Repairing Relining Denture Resin |
| 2 Feb 1995 | K945711 | EXCEL-P FORMULA AUTO-CURE DENTURE BASE | St. George Technology, Inc. | EBI Rebasing Repairing Relining Denture Resin |
| 18 Jan 1994 | K934019 | EXCEL FORMULA HEAT-AUTO CURE DENT BASE/REPAIR/ORTHO | St. George Technology, Inc. | EBI Rebasing Repairing Relining Denture Resin |
| 21 Aug 1991 | K910676 | INTRAORAL DENTAL WAX | Pemaco, Inc. | EGD Intraoral Dental Wax |
| 6 Nov 1989 | K895566 | PEMACO ECONOMY BASE PLATE WAX-MEDIUM SOFT | Pemaco, Inc. | EGD Intraoral Dental Wax |
| 6 Nov 1989 | K895562 | PEMACO 2000 INTRAORAL DENTAL WAX | Pemaco, Inc. | EGD Intraoral Dental Wax |
| 6 Nov 1989 | K895564 | PEMACO BITE BLOCK RODS-MEDIUM SOFT & MEDIUM HARD | Pemaco, Inc. | EGD Intraoral Dental Wax |
| 6 Nov 1989 | K895561 | PEMACO 3000 INTRAORAL DENTAL WAX | Pemaco, Inc. | EGD Intraoral Dental Wax |
| 6 Nov 1989 | K895563 | PEMACO BITE WAX SHEETS | Pemaco, Inc. | EGD Intraoral Dental Wax |
| 24 Oct 1989 | K895565 | PEMACO ECONOMY BASE PLATE WAX-MEDIUM HARD | Pemaco, Inc. | EGD Intraoral Dental Wax |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| GARRECO, LLCFDA reg. 3009426332 | Heber Springs, AR, United States | Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10042968). 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.