Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007518500

FEI Number

3007518500

Entity Name

SAGEMAX BIOCERAMICS, INC.

City/State/Country

Federal Way, WA, US

Establishment Address

34210 9th Ave S Suite 118, Federal Way, WA 98003, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

SAGEMAX BIOCERAMICS, INC. (Owner Number: 10028594)

Owner / Operator Contact Address

34210 9th Ave. S., Suite 118, Federal Way, WA 98003, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K120134

PMA Number

N/A

All Registered Proprietary Names

SAGEWAX Wax Disc NexxZr T NexxZr S NexxZr Plus NexxZr T Preshaded 19 NexxZr Plus Preshaded 19 NexxZr T Coloring Liquids NexxZr Effect Coloring Liquids NexxZr + Coloring Liquids NexxZr + Multi NexxZr + Multi 2 NexxZr T Multi Sagemax PressCeramic

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2018-07-19
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2014-10-20
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2019-02-28
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2021-02-15
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2020-12-17

Official Correspondent

Lucina Celeste

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SAGEMAX BIOCERAMICS, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K143656	H.C. Starck Ceramics GmbH	StarCeram® Z-Nature, StarCeram® Z-Smile	2015-07-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0017-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain
Z-0018-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental porcelain
Z-0019-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring dental porcelain
Z-0020-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For coloring dental porcelain
Z-0021-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color A1 60ml, art. no. 681050, Product Usage: For coloring dental porcelain

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007518500. Last updated year: 2026. Please use registration number 3007518500 when referencing this establishment in official correspondence.