Facility

SAGEMAX BIOCERAMICS, INC.

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

1inspections · worst NAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3007518500
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	34210 9th Ave S Suite 118 Federal Way, WA, US 98003
Registration status	Active · expires 2026
Parent company	SAGEMAX BIOCERAMICS, INC. (owner-operator 10028594)
Brand names	NexxZr T Multi

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (1)

Powder, Porcelain
Product code EIH (opens in a new tab) · Class II · Dental · 21 CFR 872.6660

Recalls & enforcement

Class IIOngoing2025-12-11
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.

FDA inspections (1)

NAI2017-10-13
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by SAGEMAX BIOCERAMICS, INC.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “SAGEMAX BIOCERAMICS, INC. (FEI 3007518500) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3007518500-sagemax-bioceramics-inc/

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