Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009432160

FEI Number

3009432160

Entity Name

anax USA

City/State/Country

Ardmore, OK, US

Establishment Address

406 I ST NW ARDMORE, Ardmore, OK 73401, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

anaxdent North America (Owner Number: 10039879)

Owner / Operator Contact Address

406 I ST NW, Ardmore, OK 73401, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K150432

PMA Number

N/A

All Registered Proprietary Names

Pekkton Ivory anaxdent New Outline CM Connect Soprano Soprano Surface Celara Extended-Pour Alginate anaxcam The Show anaxPINK anaxGUM anaxBLEND Mock-up Direct ACRYLINE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2015-12-31
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2012-02-16
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2019-03-07
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2021-05-13
ELW	Material, Impression	Dental	Class 2	872.3660	2015-12-31
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2023-01-04
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2012-02-16
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2013-04-04
MQC	Mouthguard, Prescription	Unknown	Class U	N/A	2020-09-09
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2020-09-09
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2020-09-09

Official Correspondent

Tay Harvey

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

anaxdent North America

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
K211871	Faico Medical, LLC	FAICO Dental Implant System and CAD/CAM Abutments	2021-11-18
K143656	H.C. Starck Ceramics GmbH	StarCeram® Z-Nature, StarCeram® Z-Smile	2015-07-09
K952614	Dentsply Intl.	JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL	1996-08-13
K070591	Union Dental S.A./Unidesa.Odi	REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH	2007-05-11
K915276	Nobelpharma USA, Inc.	DENTURE PLASTIC TEETH,76 ELM	1992-02-03

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2018	Implant Direct Sybron Manufacturing, LLC	2	Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
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

Similar Registrations

Registration Number	Establishment Name	Location
3017374693	STRATASYS LTD - Headquarter	Rehovot Central, IL
3001389926	DENTAL MANUFACTURING SPA	Badia Polesine Rovigo, IT
3007210751	DENTSCARE LTDA	Joinville Santa Catarina, BR
1410097	GC AMERICA INC.	ALSIP, IL, US
3015396763	MGNEWTON LTD.	Gyengsan-si Gyeongbuk, KR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009432160. Last updated year: 2026. Please use registration number 3009432160 when referencing this establishment in official correspondence.