510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Sagemax Bioceramics, Inc.

Federal Way, WA, US

SAGEMAX BIOCERAMICS, INC. appears in FDA device records in Federal Way, WA. FDA records list 2 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
2
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 2 510(k) clearances for Sagemax Bioceramics, Inc. between 2006 and 2014. The busiest year on record is 2006, with 1. The most recent is 2014, with 1.

Clearances by year, as a table
510(k) clearance decisions for Sagemax Bioceramics, Inc., by decision year
YearClearances
20061
20141
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K130991NEXXZR(TM)T AND NEXXZR(TM)SEIHSubstantially Equivalent
K062695SAGEMAX Z-BLANKEIHSubstantially Equivalent

Registered establishments

FDA registered establishments for Sagemax Bioceramics, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30075185003007518500SAGEMAX BIOCERAMICS, INC.34210 9th Ave S Suite 118, Federal Way, WA 98003 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2356-2026NexxZr T Multi A3.5 W98-16mm, REF: 745451Yttrium-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.Class IIOpen, Classified

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain