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anax USA: FDA-registered device maker in Ardmore, OK, United States, 10 510(k) clearances

Name: anax USA FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

anax USA is registered with the FDA (registration 3009432160) in Ardmore, OK, United States. It lists 9 device types. The FDA files 10 510(k) clearances under its listings, the newest dated December 18, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3009432160
Address: 406 I ST NW Ardmore, Ardmore, OK, United States, 73401
Owner or operator: anaxdent North America (10039879)
Roles: Complaint file establishment
First device listed: February 16, 2012
Registered through: 2026
Brand names listed: 3Delta UNlimited, ACRYLINE, CM Connect, Celara Extended-Pour Alginate, Mock-up Direct, New Outline, Pekkton Ivory, Soprano and more

Devices it lists

Device	Product code	Class	Role	Source
Abutment, Implant, Dental, Endosseous	NHA	2	Complaint file establishment	accessdata.fda.gov
Additively Manufactured, Preformed, Resin Denture Tooth	PZY	2	Complaint file establishment	accessdata.fda.gov
Crown And Bridge, Temporary, Resin	EBG	2	Complaint file establishment	accessdata.fda.gov
Denture, Plastic, Teeth	ELM	2	Complaint file establishment	accessdata.fda.gov
Material, Impression	ELW	2	Complaint file establishment	accessdata.fda.gov
Material, Tooth Shade, Resin	EBF	2	Complaint file establishment	accessdata.fda.gov
Mouthguard, Prescription	MQC	U	Complaint file establishment	accessdata.fda.gov
Powder, Porcelain	EIH	2	Complaint file establishment	accessdata.fda.gov
Resin, Denture, Relining, Repairing, Rebasing	EBI	2	Complaint file establishment	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 18, 2024	K243720	3Delta UNlimited	EBF	Substantially Equivalent	Deltamed GmbH	accessdata.fda.gov
January 15, 2020	K192251	Livento Press, Soprano 10, Soprano	EIH	Substantially Equivalent	Cendres+Metaux SA	accessdata.fda.gov
June 15, 2018	K173908	DESS Dental Smart Solutions	NHA	Substantially Equivalent	Terrats Medical SL	accessdata.fda.gov
August 8, 2017	K170588	DESS Dental Smart Solutions	NHA	Substantially Equivalent	Terrats Medical SL	accessdata.fda.gov
August 14, 2015	K150432	IDODENTINE DISC, IDODENTINE BLOCK	EBG	Substantially Equivalent	Union Dental S.A.	accessdata.fda.gov
February 21, 2013	K123638	PEKKTON IVORY	EBG	Substantially Equivalent	Cendres & Metaux SA	accessdata.fda.gov
January 26, 2012	K112044	ANAXBLEND MODEL 20XXX (SEVERAL), ANAXGUM MODEL 25XXX (U), MOCK-UP DIRECT MODEL 240XXX (U), MOCK-UP DIRECT FLOW MODEL 24A	EBF	Substantially Equivalent	Anaxdent GmbH	accessdata.fda.gov
October 26, 2005	K052073	FUTURAPRESS LT, N AND HP, FUTURAJET, FUTURASELF, FUTURAGEN AND FUTURACRYL 2000	EBI	Substantially Equivalent	Schutz-Dental GmbH	accessdata.fda.gov
October 30, 2002	K023079	NEW OUTLINE	EBG	Substantially Equivalent	Anaxdent GmbH	accessdata.fda.gov
May 21, 1998	K981091	NEOCOLLOID, ORTHOPRINT	ELW	Substantially Equivalent	Zhermack S.P.A.	accessdata.fda.gov

Compare with other makers

Updated December 18, 2024. 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.