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

Shelton, CT, US

CENTRIX, INC. appears in FDA device records in Shelton, CT. FDA records list 47 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
47
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 47 510(k) clearances for Centrix, Inc. between 1979 and 2025. The busiest year on record is 1992, with 4. The most recent is 2025, with 1.

Clearances by year, as a table
510(k) clearance decisions for Centrix, Inc., by decision year
YearClearances
19791
19811
19831
19841
19851
19861
19871
19882
19893
19924
19932
19943
19952
19963
19974
19984
19991
20001
20011
20022
20092
20111
20121
20141
20161
20231
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K250714FluoroDose VarnishLBHSubstantially Equivalent
K222459Centrix FluoroSilver Silver Diamine Fluoride 38%PHRSubstantially Equivalent
K152826NoCordELWSubstantially Equivalent
K140144BENDA WEDGEEJBSubstantially Equivalent
K120176SENZZZZZ AWAYLBHSubstantially Equivalent
K111348RE / STASIS (TM) GINGIVAL RETRACTION PASTEMVLSubstantially Equivalent
K092384LIQUICORDMVLSubstantially Equivalent
K091380CORDCAPMVLSubstantially Equivalent
K021131CHLORAPREPLBHSubstantially Equivalent
K021146D/SENSE 1-STEPEJKSubstantially Equivalent
K010133VERSALUXEBZSubstantially Equivalent
K001050CALCIJECTEJKSubstantially Equivalent
K992629D/SENSE II (GREEN-OR) DENTIN DESENSITIZERLBHSubstantially Equivalent
K981972GREEN-OR DENTIN DESENSITIZERLBHSubstantially Equivalent
K982665JUMBO SILVER-REINFORCED GLASS IONOMEREMASubstantially Equivalent
K980568JUMBO GLASS IONOMER CEMENTEMASubstantially Equivalent
K973285D/SENSE-TKLESubstantially Equivalent
K973257VERSAETCHEBFSubstantially Equivalent
K971121ENCORE BONDKLESubstantially Equivalent
K965138DENTINSENSE B/CKLESubstantially Equivalent
K964735DENTINSENSEKLESubstantially Equivalent
K963927TEAM CARIES INDICATORLFCSubstantially Equivalent
K963311TEAM ETCHEBFSubstantially Equivalent
K961190GLY-ETCHEBCSubstantially Equivalent
K955279D-SENSEKLESubstantially Equivalent
K952728RETRACELWSubstantially Equivalent
K935151HYDROCOLLOID HEATING UNITELWSubstantially Equivalent
K933507NEEDLETUBE SYRINGE CARTRTIDGEEJKSubstantially Equivalent
K933999STERIBASE (ACCUBASE)EJKSubstantially Equivalent
K926368APPLICATOR NOZZLEEKJSubstantially Equivalent
K931084TEMPITEMASubstantially Equivalent
K921173TYPE 1 DENTAL CEMENTEMASubstantially Equivalent
K921174COMPOSITE RESIN CORE PASTE MATERIALEBFSubstantially Equivalent
K922638TEMPIT-EEMASubstantially Equivalent
K913974ACCESS IMPRESSION BARRELEIDSubstantially Equivalent
K890140PHOSPHORIC-ACID ETCHING GELEBFSubstantially Equivalent
K890064DENTAL SYRINGE APPLICATION TIPEKJSubstantially Equivalent
K885162BENDA BRUSHEKJSubstantially Equivalent
K882125CENTRIX TRI-LAMINATE POST SYSTEMELRSubstantially Equivalent
K882651CENTRIX NEEDLETUBEEKJSubstantially Equivalent
K873002MIN-IDENTOFLEXEHJSubstantially Equivalent
K861581CENTRIX PCR MOLAR MATRIX FORMS (BANDS)DZNSubstantially Equivalent
K853282CENTRIX RIBBON TUBESEIDSubstantially Equivalent
K833725PRE-LOADED C-R TUBES FOR SYRINGEEBFSubstantially Equivalent
K832662DENTAL SYRINGE SYSTEM-VARIOUS STYLESKXRSubstantially Equivalent
K811831MULTI-PURPOSE DENTAL SYRINGEEJISubstantially Equivalent
K792461CENTRIX MKIV ENDODONTIC DELIVERYEICSubstantially Equivalent

Registered establishments

FDA registered establishments for Centrix, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
12814121281412CENTRIX, INC.770 River Rd, Shelton, CT 06484 US2026and 9 more, listed in full below

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

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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