Manufacturer registered with FDA
Sagemax Bioceramics, Inc.
Federal Way, WA, United States. Lists 2 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 2
- Brands and models
- 14
- 510(k) clearances
- 22006–2014
- Markets registered in
- 1247 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2000–2026
Registered in 12 markets
Where regulators' registries name Sagemax Bioceramics, 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 | Sagemax Bioceramics, Inc. | 2 clearances | 2006–2014 | Below |
| Canada | Health Canada | Registration holder | SAGEMAX BIOCERAMICS, INC. | 18 | 2013–2025 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Sagemax Bioceramics Inc | 6 | 2024–2025 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | SAGEMAX BIOCERAMICS INC. | 5 | 2019–2023 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Sagemax Bioceramics, Inc. | 5 | 2013–2022 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Sagemax Bioceramics, Inc | 3 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Sagemax Bioceramics Inc. | 3 | 2013–2019 | Pure Global AI |
| Australia | TGA | Manufacturer | Sagemax Bioceramics Inc | 2 | 2015–2024 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Sagemax BIoceramics Inc | 2 | — | Pure Global AI |
| China | NMPA | Registration holder | 西捷美生物陶瓷有限公司Sagemax Bioceramics Inc | 1 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Sagemax Bioceramics, Inc. | 1 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Sagemax Bioceramics 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 Sagemax Bioceramics, 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 |
|---|---|---|---|---|
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Maker | NexxZr + Coloring LiquidsNexxZr + MultiNexxZr + Multi 2NexxZr Effect Coloring LiquidsNexxZr PlusNexxZr Plus Preshaded 19NexxZr SNexxZr TNexxZr T Coloring LiquidsNexxZr T Multi 2 moreNexxZr T Preshaded 19Sagemax PressCeramic | 2014 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | SAGEWAXWax Disc | 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 Sagemax Bioceramics, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 10 Feb 2014 | K130991 | NEXXZR(TM)T AND NEXXZR(TM)S | EIH Porcelain Powder |
| 20 Oct 2006 | K062695 | SAGEMAX Z-BLANK | EIH Porcelain Powder |
Some of these clearances are listed with FDA today by another company: Dental Laboratory Milling Supplies LLC, DBA Digital Dental, (1), Ivoclar Vivadent, AG (1), Jensen Industries, Inc. (1).
Also lists devices cleared under other names
Sagemax Bioceramics, 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: Wieland Dental + Technik GmbH & Co. KG (2), Ivoclar Vivadent, AG (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 16 Dec 2015 | K152118 | Zenostar MT, Zenostar Color Liquids | Wieland Dental + Technik GmbH & Co. KG | EIH Porcelain Powder |
| 5 Jan 2015 | K142233 | zenostar MO, Zenostar T, Zenostar VisualiZr | Wieland Dental + Technik GmbH & Co. KG | EIH Porcelain Powder |
| 25 Jun 2012 | K120134 | IPS E.MAX PRESS MULTI | Ivoclar Vivadent, AG | EIH Porcelain Powder |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SAGEMAX BIOCERAMICS, INC.FDA reg. 3007518500 | Federal Way, WA, United States | Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10028594). 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.