Manufacturer registered with FDA
Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO
BREMEN, Germany. Lists 10 dental device types with FDA across 1 registered establishment, and holds 4 510(k) clearances as applicant.
- Device types listed
- 10
- Brands and models
- 48
- 510(k) clearances
- 41998–2013
- Markets registered in
- 22 registrations outside the US
- Establishments
- 1Germany
510(k) clearances per year, 1990–2026
Registered in 2 markets
Where regulators' registries name Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO 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 | Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO | 4 clearances | 1998–2013 | Below |
| South Korea | MFDS | Manufacturer | BEGO Bremer Goldschlaegerei Wilh. Herbst GmbH & Co. | 2 | 2003–2003 | 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 Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO 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 Shade MaterialEBF · Class 2 | Dental composites | Maker | Final CrownPermanent CrownSprintRay CrownVarseoSmile Crown plusVarseoSmile TriniQ | 2020 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | Temporary CBVarseoSmile TempVarseoSmile TriniQ | 2020 |
| Resin Denture Tooth Preformed Additively ManufacturedPZY · Class 2 | Denture resins & teeth | Maker | VarseoSmile TeethVarseoSmile TriniQ | 2021 |
| Orthodontic Screw Expansion RetainerDYJ · Class 1 | Retainers, expanders & headgear | Maker | Mediloy RPD | 1978 |
| Orthodontic Material BandDYO · Class 1 | Orthodontic wires & bands | Maker | Mediloy RPD | 2025 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Maker | Mediloy RPD | 2025 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | Mediloy RPD | 2025 |
| Base Metal AlloyEJH · Class 2 | Dental alloys | Maker | CoCr DG1LOETSTAEBE CO-CRMediloy EcoMediloy M-CoMediloy M-Ti4Mediloy M-Ti5Mediloy RPDMediloy S-CoMediloy Titan Grade 5 SLM PulverWIROBOND 280 15 moreWIROBOND CWirobond C+WIROBOND LOETSTAEBEWIROBOND SGWIRON 99WIRON LIGHTWIRON LOTWIRONITWIRONIT EXTRA-HARDWIRONIT LAWIRONIUMWIRONIUM EXTRAHARDWIRONIUM PLUSWironium RPWiroweld | 1978 |
| Alloy Other Noble MetalEJS · Class 2 | Dental alloys | Maker | AuroLloyd MBegoPal 300BegoPal SBegoStarBegoStar ECOECO d'OR | 1978 |
| Gold-Based Noble Metal AlloyEJT · Class 2 | Dental alloys | Maker | BEGOCER GBio PontoStar XLPontoLloyd P | 2010 |
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 Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 12 Nov 2013 | K132102 | BECE CAD ZIRKON HT+ | EIH Porcelain Powder |
| 14 Mar 2013 | K123929 | BEGOPAL+ | EJH Base Metal Alloy |
| 6 Jul 2009 | K090434 | BECE PRESS | EIH Porcelain Powder |
| 28 Oct 1998 | K983081 | BEGOPAL 300 | EJS Alloy Other Noble Metal |
Some of these clearances are listed with FDA today by another company: Monde Dental Lab (1).
Also lists devices cleared under other names
Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO 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: Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG (3).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 9 Nov 2023 | K233596 | VarseoSmile TriniQ | Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG | EBF Resin Tooth Shade Material |
| 23 Jun 2020 | K201668 | VarseoSmile Crown plus | Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG | EBF Resin Tooth Shade Material |
| 18 May 2020 | K193553 | VarseoSmile Temp | Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG | EBG Resin Temporary Crown and Bridge |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| BEGO BREMER GOLDSCHLAEGEREI WILH. HERBST GMBH & CO. KGFDA reg. 9611514 | BREMEN, Germany | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8010221). 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.