Manufacturer registered with FDA
Deltamed GmbH
FRIEDBERG, Germany. Lists 13 dental device types with FDA across 1 registered establishment, and holds 6 510(k) clearances as applicant.
- Device types listed
- 13
- Brands and models
- 72
- 510(k) clearances
- 62011–2024
- Markets registered in
- 11218 registrations outside the US
- Establishments
- 1Germany
510(k) clearances per year, 2007–2026
Registered in 11 markets
Where regulators' registries name Deltamed GmbH as the manufacturer or the registration holder of a device.
RegisteredHome: GermanyOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Deltamed GmbH | 6 clearances | 2011–2024 | Below |
| European Union | EUDAMED | Registration holder | Delta Med SPADeltamed GmbH | 94 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | DELTAMED GMBH | 86 | 2004–2025 | Pure Global AI |
| Australia | TGA | Manufacturer | DeltaMed GmbH | 10 | 2006–2024 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | DELTAMED GMBHDeltamed GMBH | 8 | 2009–2024 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | DELTAMED GMBH | 6 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | DeltaMed GmbH | 4 | 2023–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | DeltaMed GmbH | 4 | 2012–2012 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | DELTAMED GMBH | 3 | 2019–2021 | Pure Global AI |
| Israel | AMAR | Manufacturer | DeltaMed GmbH | 2 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | DELTAMED GmbH | 1 | 2020–2020 | 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 Deltamed GmbH 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 | Brush & SculptCosmeCoreCreative Color® Clear Liquid ResinCreative Color® OpaquerCreative Color® Pink OpaqueCreative Color® TintPRO Resins Arch XPRO Resins Crown XRenamel® BulkfillRenamel® De-Mark 8 moreRenamel® Flowable MicrohybridRenamel® Gingafill®Renamel® MicrofillRenamel® MicrohybridRenamel® NANO +plusRS VIVO C&B Ultimate3Delta Crown3Delta UNlimited | 2008 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | ACRIFIX BonderACRIFIX rosa-opakACRIFIX rosa/pinkACRIFIX rosa/pink SetPRO Resins Arch XPRO Resins Base XPRO Resins Denture BondPRO Resins Denture FixRS VIVO C&B Ultimate3Delta Denture Base 3 more3Delta Denture Bond3Delta Denture Fix3Delta UNlimited | 2022 |
| Dental CementEMA · Class 2 | Dental cements | Maker | Insure®Insure® LiteInsure® Lite AutomixInsure® UNIVERSALInsure® UNIVERSAL AutoMixPrevue® | 2008 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | P pro Crown & BridgePRO Resins Arch XRS VIVO C&B Ultimate3Delta Etemp3Delta UNlimited | 2020 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Maker | ACRIFIX BonderInsure® SilanatorPRO Resins Base XPRO Resins Denture BondPRO Resins Denture Fix3Delta Denture Base3Delta Denture Bond3Delta Denture Fix | 2006 |
| Resin Denture Tooth Preformed Additively ManufacturedPZY · Class 2 | Denture resins & teeth | Maker | PRO Resins Arch XPRO Resins Tooth XRS VIVO C&B Ultimate3Delta Denture Teeth3Delta UNlimited | 2022 |
| Orthodontic Space Preformed MaintainerDYT · Class 1 | Retainers, expanders & headgear | Maker | P pro Splint | 2020 |
| Pit and Fissure Sealant and ConditionerEBC · Class 2 | Sealants & varnishes | Maker | COSMESEAL® ClearCOSMESEAL® Filled | 2008 |
| Resin Filling Material CoatingEBD · Class 2 | — | Maker | Renamel® Flowable Microfill | 2008 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | P pro Impression Tray GreenRS VIVO Tray3Delta Tray3Delta Tray beige3Delta Tray Rose | 2018 |
| Shellac Base PlateEEA · Class 1 | — | Maker | P pro Try-InRS VIVO Try-In3Delta Try-In XT | 2018 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | Enamelize | 2008 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | P Pro Surgical Guide ClearPRO Resins Guide XRS VIVO Guide3Delta Guide XT | 2018 |
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 Deltamed GmbH as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 18 Dec 2024 | K243720 | 3Delta UNlimited | EBF Resin Tooth Shade Material |
| 6 Apr 2023 | K230341 | ACRIFIX | EBI Rebasing Repairing Relining Denture Resin |
| 10 Jan 2022 | K212541 | 3Delta Denture Base - 3Delta Denture Bond - 3Delta Denture Fix | EBI Rebasing Repairing Relining Denture Resin |
| 6 Dec 2021 | K211804 | 3Delta Crown | EBF Resin Tooth Shade Material |
| 31 Jul 2020 | K200039 | P pro Crown & Bridge | EBG Resin Temporary Crown and Bridge |
| 18 Feb 2011 | K102776 | EXTRA-ORAL, ADDITIVE COMPUTER AIDED MANUFACTURE AND CURING SYSTEM | EBG Resin Temporary Crown and Bridge |
Also lists devices cleared under other names
Deltamed GmbH 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: Cosmedent, Inc. (15).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 24 Jul 2024 | K240714 | Insure® Universal; Insure® Universal Automix | Cosmedent, Inc. | EMA Dental Cement |
| 11 Oct 2022 | K222435 | Renamel® Microhybrid ;Renamel® Flowable Microhybrid | Cosmedent, Inc. | EBF Resin Tooth Shade Material |
| 24 Jun 2021 | K211259 | Renamel Bulkfill | Cosmedent, Inc. | EBF Resin Tooth Shade Material |
| 5 Dec 2017 | K172707 | Renamel Microfill | Cosmedent, Inc. | EBF Resin Tooth Shade Material |
| 24 Feb 2017 | K163480 | Renamel NANO +plus | Cosmedent, Inc. | EBF Resin Tooth Shade Material |
| 20 Nov 2009 | K092730 | COSMEDENT BRUSHABLE COMPOSITE | Cosmedent, Inc. | EBF Resin Tooth Shade Material |
| 21 Oct 2005 | K052501 | MULTIPLE RESIN TOOTH BONDING AGENT | Cosmedent, Inc. | KLE Resin Tooth Bonding Agent |
| 1 Dec 2004 | K042823 | COSMEDENT PIT & FISSURE SEALANT | Cosmedent, Inc. | EBC Pit and Fissure Sealant and Conditioner |
| 3 Jun 2004 | K040994 | COSMEDENT CORE PASTE | Cosmedent, Inc. | EBF Resin Tooth Shade Material |
| 10 Feb 1998 | K974494 | RENAMEL FLOWABLE COMPOSITE | Cosmedent, Inc. | EBD Resin Filling Material Coating |
| 16 Jun 1992 | K921820 | RENAMEL ESTHETIC RESTORATIVE SYSTEM, MODIFICATION | Cosmedent, Inc. | EBF Resin Tooth Shade Material |
| 10 Jan 1990 | K894477 | INSURE MATCH MATE PORCELAIN VENEER TRY-IN SYSTEM | Cosmedent, Inc. | EMA Dental Cement |
| 29 Dec 1987 | K873356 | INSURE PORCELAIN VENEER BONDING SYSTEM | Cosmedent, Inc. | EMA Dental Cement |
| 12 Aug 1986 | K862912 | RENAMELIZE POLISHING PASTE | Cosmedent, Inc. | EJR Oral Cavity Abrasive Polishing Agent |
| 13 Mar 1986 | K854755 | RENAMEL ESTHETIC RESTORATIVE SYSTEM | Cosmedent, Inc. | EBF Resin Tooth Shade Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DELTAMED GMBHFDA reg. 3002789526 | FRIEDBERG Hesse, Germany | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9026386). 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.