Registered with FDA
anaxdent North America
Ardmore, OK, United States. Lists 8 dental device types with FDA across 1 registered establishment.
- Device types listed
- 8
- Brands and models
- 17
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What anaxdent North America 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 Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Lister | anaxdentNew OutlinePekkton Ivory3Delta UNlimited | 2012 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Lister | ACRYLINE3Delta UNlimited | 2013 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Lister | anaxBLENDanaxGUManaxPINKMock-up Direct3Delta UNlimited | 2012 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Lister | CM Connect | 2019 |
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Lister | SopranoSoprano Surface | 2021 |
| Teeth Plastic DentureELM · Class 2 | Denture resins & teeth | Lister | anaxcam The Show | 2023 |
| Impression MaterialELW · Class 2 | Impression materials | Lister | Celara Extended-Pour Alginate | 2015 |
| Resin Denture Tooth Preformed Additively ManufacturedPZY · Class 2 | Denture resins & teeth | Lister | 3Delta UNlimited | 2025 |
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
anaxdent North America 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: Terrats Medical, S.L. (2), anax dent GmbH (2), Deltamed GmbH (1), Cendres+Metaux SA (1), Union Dental S.A. (1), Cendres & Metaux SA (1), Schutz Dental GmbH (1), Dentsply Sirona, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 18 Dec 2024 | K243720 | 3Delta UNlimited | Deltamed GmbH | EBF Resin Tooth Shade Material |
| 15 Jan 2020 | K192251 | Livento Press, Soprano 10, Soprano | Cendres+Metaux SA | EIH Porcelain Powder |
| 15 Jun 2018 | K173908 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA Endosseous Dental Implant Abutment |
| 8 Aug 2017 | K170588 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA Endosseous Dental Implant Abutment |
| 14 Aug 2015 | K150432 | IDODENTINE DISC, IDODENTINE BLOCK | Union Dental S.A. | EBG Resin Temporary Crown and Bridge |
| 21 Feb 2013 | K123638 | PEKKTON IVORY | Cendres & Metaux SA | EBG Resin Temporary Crown and Bridge |
| 26 Jan 2012 | K112044 | ANAXBLEND MODEL 20XXX (SEVERAL), ANAXGUM MODEL 25XXX (U), MOCK-UP DIRECT MODEL 240XXX (U), MOCK-UP DIRECT FLOW MODEL 24A | anax dent GmbH | EBF Resin Tooth Shade Material |
| 26 Oct 2005 | K052073 | FUTURAPRESS LT, N AND HP, FUTURAJET, FUTURASELF, FUTURAGEN AND FUTURACRYL 2000 | Schutz Dental GmbH | EBI Rebasing Repairing Relining Denture Resin |
| 30 Oct 2002 | K023079 | NEW OUTLINE | anax dent GmbH | EBG Resin Temporary Crown and Bridge |
| 21 May 1998 | K981091 | NEOCOLLOID, ORTHOPRINT | Dentsply Sirona, Inc. | ELW Impression Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| anax USAFDA reg. 3009432160 | Ardmore, OK, United States | Complaint file establishment |
Other names on FDA records
anax USA
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10039879). 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.