Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2126387

FEI Number

2126387

Entity Name

ZIRC DENTAL PRODUCTS, INC.

City/State/Country

BUFFALO, MN, US

Establishment Address

3918 HWY 55 S.E., BUFFALO, MN 55313, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

ZIRC DENTAL PRODUCTS, INC. (Owner Number: 2126387)

Owner / Operator Contact Address

3918 Highway 55 SE, Buffalo, MN 55313, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Water Wise Starter Kit, Water Wise Replacement Bottle SE Cushions, Lingua-Fix, Saliva Ejector, Saliva Ejector Valve, Saliva Ejector Tip Mr. Thirsty One-Step, Mr. Thirsty One-Step Comfort Kit Pink Petal Mixing Sticks Mighty Mixer Spatula Derlin Spatula Cement Spatula Mixing Wells Mighty Mixer Bowl Airway Armor Latex-Free Insti-Dam Relaxed Fit, Latex-Free Insti-Dam Matrix Dispenser Ergo Grip Simple Stem Mirror Handle Ergo Grip Cone Socket Mirror Handle Soft Grip Cone Socket Mirror Handle

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EBR	Unit, Suction Operatory	Dental	Class 1	872.6640	2025-02-24
DYN	Mouthpiece, Saliva Ejector	Dental	Class 1	872.6640	1999-11-12
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	1999-11-12
EIE	Dam, Rubber	Dental	Class 1	872.6300	2000-09-13
JEP	Retainer, Matrix	Dental	Class 1	872.4565	2025-02-24
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2006-08-29

Official Correspondent

Phuc Ngo

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ZIRC DENTAL PRODUCTS, INC.

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
K781592	Henry Schein, Inc.	SURGICAL ASPIRATOR TIPS	1978-12-04
K040797	Britesmile, Inc.	BRITESMILE MASKING CREAM	2004-04-02
K831136	Almore Intl., Inc.	DOUBLE BOW TOOTH SEPARATOR	1983-06-08

Similar Registrations

Registration Number	Establishment Name	Location
3043648115	DEBO MEDICAL TECHNOLOGY (SHIJIAZHUANG) CO., LTD.	Shijiazhuang Hebei, CN
3017181414	JIANGSU YONGFA MEDICAL EQUIPMENT TECHNOLOGY CO., LTD	Zhangjiagang City Jiangsu, CN
3019103	BEAVERSTATE DENTAL, INC.	NEWBERG, OR, US
3010373263	JIANGSU SAIKANG MEDICAL EQUIPMENT CO., LTD	Zhangjiagang Jiangsu, CN
3008770655	BEYES DENTAL INC	Toronto Ontario, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2126387. Last updated year: 2026. Please use registration number 2126387 when referencing this establishment in official correspondence.