Manufacturer registered with FDA
Pan-Am Dental, Inc.
Savannah, GA, United States. Lists 7 dental device types with FDA across 2 registered establishments.
- Device types listed
- 7
- Brands and models
- 9
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 2United States
Devices listed with FDA
What Pan-Am Dental, 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 |
|---|---|---|---|---|
| Gold-Based Noble Metal AlloyEJT · Class 2 | Dental alloys | Lister | Alloy, gold-based noble metalALLOY, OTHER NOBLE METAL | 2007 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | Abutment, Implant, Dental, Endosseous - BiodentaPreat Abutments | 2022 |
| Base Metal AlloyEJH · Class 2 | Dental alloys | Lister | ALLOY, METAL, BASE | 2007 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | Preat Abutments | 2022 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | RESIN, DENTURE, RELINING, REPAIRING, REBASING | 2007 |
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Lister | POWDER, PORCELAIN | 2007 |
| Alloy Other Noble MetalEJS · Class 2 | Dental alloys | Lister | ALLOY, OTHER NOBLE METAL | 2007 |
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
Pan-Am Dental, 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: Ivoclar North America, Inc. (5), Bego U.S.A. (1), Precious Chemicals U.S.A., Inc. (1), Jeneric Ind. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 4 Sep 2003 | K032136 | WIROBOND C | Bego U.S.A. | EJH Base Metal Alloy |
| 6 Mar 2001 | K010381 | D.SIGN 30 | Ivoclar North America, Inc. | EJH Base Metal Alloy |
| 28 Apr 1994 | K932243 | GALLOR DENTAL MATERIAL & COPING INTRACAST TECHNOLO | Precious Chemicals U.S.A., Inc. | EJT Gold-Based Noble Metal Alloy |
| 25 Oct 1991 | K913372 | IPS EMPRESS | Ivoclar North America, Inc. | EIH Porcelain Powder |
| 26 Feb 1991 | K905329 | WILL-CERAM W | Ivoclar North America, Inc. | EJT Gold-Based Noble Metal Alloy |
| 24 Dec 1990 | K905324 | WILL-CERAM W-1 | Ivoclar North America, Inc. | EJT Gold-Based Noble Metal Alloy |
| 16 Apr 1990 | K896130 | SR-IVOCAP | Ivoclar North America, Inc. | EBI Rebasing Repairing Relining Denture Resin |
| 22 Oct 1982 | K822950 | RX UNIVERSAL | Jeneric Ind. | EJS Alloy Other Noble Metal |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| PAN-AM DENTAL, INC.FDA reg. 3004711948 | SAVANNAH, GA, United States | Contract manufacturer |
| PAN-AM DENTAL, INC.FDA reg. 3040605150 | Sandy, UT, United States | Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9066791). 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.