Data / Medical devices / United States / Sagemax Bioceramics, Inc.
Sagemax Bioceramics, Inc.: FDA-registered device maker in Federal Way, WA, United States, 4 510(k) clearances
Sagemax Bioceramics, Inc. is registered with the FDA (registration 3007518500) in Federal Way, WA, United States. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated December 16, 2015. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3007518500
- Address
- 34210 9th Ave S Suite 118, Federal Way, WA, United States, 98003
- Owner or operator
- SAGEMAX BIOCERAMICS, INC. (10028594)
- Roles
- Specification developer
- First device listed
- October 20, 2014
- Registered through
- 2026
- Brand names listed
- NexxZr + Coloring Liquids, NexxZr + Multi, NexxZr + Multi 2, NexxZr Effect Coloring Liquids, NexxZr Plus, NexxZr Plus Preshaded 19, NexxZr S, NexxZr T and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powder, Porcelain | EIH | 2 | Specification developer | accessdata.fda.gov |
| Wax, Dental, Intraoral | EGD | 1 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 16, 2015 | K152118 | Zenostar MT, Zenostar Color Liquids | EIH | Substantially Equivalent | Wieland Dental + Technik GmbH & Co. KG | accessdata.fda.gov |
| January 5, 2015 | K142233 | zenostar MO, Zenostar T, Zenostar VisualiZr | EIH | Substantially Equivalent | Wieland Dental + Technik GmbH & Co. KG | accessdata.fda.gov |
| February 10, 2014 | K130991 | NEXXZR(TM)T AND NEXXZR(TM)S | EIH | Substantially Equivalent | Sagemax Bioceramics, Inc. | accessdata.fda.gov |
| June 25, 2012 | K120134 | IPS E.MAX PRESS MULTI | EIH | Substantially Equivalent | Ivoclar Vivadent, AG | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 11, 2025 | 98823 | Class II | Ongoing | NexxZr T Multi A3.5 W98-16mm, REF: 745451 | Yttrium-stabilized zirconium oxide discs for fixed all-ceramic dental restorations may have reduced or missing dentin layer and when used clinically in the patient's mouth there is an increased risk of fractures under functional stress. | accessdata.fda.gov |
Compare with other makers
Updated June 9, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.