Manufacturer registered with FDA
Aalba Dent, Inc.
Fairfield, CA, United States. Lists 3 dental device types with FDA across 1 registered establishment, and holds 27 510(k) clearances as applicant.
- Device types listed
- 3
- Brands and models
- 22
- 510(k) clearances
- 271985–2004
- Markets registered in
- 510 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 1980–2026
Registered in 5 markets
Where regulators' registries name Aalba Dent, Inc. 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 | Aalba Dent, Inc. | 27 clearances | 1985–2004 | Below |
| South Korea | MFDS | Manufacturer | Aalba Dent Inc.AALBA DENT INC · Aalba Dent, Inc · +1 | 6 | 1999–2003 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Aalba Dent, Inc. | 2 | 2014–2014 | Pure Global AI |
| Australia | TGA | Manufacturer | Aalba Dent Inc | 1 | 2011–2011 | Pure Global AI |
| China | NMPA | Registration holder | 阿尔巴登公司Aalba Dent, Inc. | 1 | — | 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 Aalba Dent, 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 |
|---|---|---|---|---|
| Base Metal AlloyEJH · Class 2 | Dental alloys | Maker | COMANDIUMCOMANDIUM IICONTINUM CCONTINUM VNPGNPG+2VERA PDIVERA PDNVERA PDSVERABOND 9 moreVERABOND 2VVERABOND IIVeraBond IIIVERABOND VVERASOFTVERASOFT ESWinzWinz 01Winz 02 | 2008 |
| Gold-Based Noble Metal AlloyEJT · Class 2 | Dental alloys | Maker | AALBA GOLD SOLDERVERA PD SOLDER | 2008 |
| Alloy Other Noble MetalEJS · Class 2 | Dental alloys | Maker | VERA SOLDER | 2008 |
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 Aalba Dent, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 4 Mar 2004 | K040180 | CONTINUM V | EJH Base Metal Alloy |
| 3 Mar 2004 | K040179 | CONTINUM | EJH Base Metal Alloy |
| 30 Dec 2003 | K033356 | VERASOFT ES | EJH Base Metal Alloy |
| 22 Jul 1998 | K982094 | VERABOND 2 | EJH Base Metal Alloy |
| 5 Jan 1998 | K972971 | NPG + 2 | EJH Base Metal Alloy |
| 16 Oct 1997 | K973265 | VERABOND 2V | EJH Base Metal Alloy |
| 10 Oct 1997 | K972607 | PLATALLOY | EJH Base Metal Alloy |
| 5 Sep 1997 | K972534 | ALFALLOY | EJS Alloy Other Noble Metal |
| 5 Sep 1997 | K972533 | VERA SOLDER | EJS Alloy Other Noble Metal |
| 15 Aug 1997 | K972632 | VERA PD SOLDER | EJT Gold-Based Noble Metal Alloy |
| 15 Aug 1997 | K972532 | AALBA GOLD SOLDER | EJT Gold-Based Noble Metal Alloy |
| 15 Aug 1997 | K972118 | VERA PDN | EJH Base Metal Alloy |
| 16 Feb 1995 | K950310 | ENDURE | EJT Gold-Based Noble Metal Alloy |
| 16 Feb 1995 | K950309 | EAGLE | EJI Cartridge Syringe |
| 29 Dec 1994 | K945910 | QUEST 2 AND 20 | EJT Gold-Based Noble Metal Alloy |
| 29 Dec 1994 | K945723 | OPULENT 76 AND 83 | EJT Gold-Based Noble Metal Alloy |
| 29 Dec 1994 | K945714 | VERABOND III | EJH Base Metal Alloy |
| 29 Dec 1994 | K945713 | VERABOND II | EJH Base Metal Alloy |
| 29 Dec 1994 | K945712 | VERABOND V | EJH Base Metal Alloy |
| 28 Mar 1994 | K940749 | LPG 5/10, LPG 10/5, LPG 10/15 AND LPG 15/10 | EJH Base Metal Alloy |
| 16 Mar 1993 | K925579 | VERASOFT CASTING ALLOY | EJH Base Metal Alloy |
| 2 Mar 1992 | K915249 | VERA PDS & VERA PDI | EJH Base Metal Alloy |
| 30 Dec 1991 | K915248 | LPG CASTING ALLOY | EJH Base Metal Alloy |
| 30 Dec 1991 | K915247 | NPG III CASTING ALLOY | EJH Base Metal Alloy |
| 16 Jun 1989 | K892419 | NPG 2 BASE METAL ALLOY | EJF Orthodontic Metal Bracket |
| 7 Nov 1986 | K863782 | NPG NONPRECIOUS CROWN AND BRIDGE ALLOY | EJH Base Metal Alloy |
| 29 May 1985 | K851569 | VERA BOND NON PERCIOUS CERAMIC ALLOY | EJH Base Metal Alloy |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| AALBA DENT, INC.FDA reg. 2916734 | FAIRFIELD, CA, United States | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 2916734). 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.