Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2029234

FEI Number

1000220911

Entity Name

PLASDENT CORP.

City/State/Country

POMONA, CA, US

Establishment Address

969 PRICE ST., POMONA, CA 91767, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device

Owner / Operator

PLASDENT CORP. (Owner Number: 9010801)

Owner / Operator Contact Address

969 PRICE ST., --, Pomona, CA 91767, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

IMPRESSION TRAY,RESIN,BITE TRAY,IMPRESSION TRAY MATERIAL Cotton Rolls, cotton roll dispenser, cotton roll applicators EARLOOP MASKS, FACE MASKS Plastic Impression Syringes, Plastic injectors, Material Carrier, Syringe Tips, Mixing & Intraoral tips, Dispenser Guns Preformed Impression Trays Valve, Snap on tips, Lever, SE Tip Accessories Face Shield, Plastic Shield, Safety Eye wears, protective eye wears, eye, ophthalmic PLASTIC BRUSHES, PLASTIC APPLICATORS TOOTHBRUSH, MANUAL-MICRO BRUSH, MINI BRUSH UNIT,SYRINGE,AIR AND/OR WATER-SYRINGE COVERS, TIP COVERS DENTAL NEEDLE TIPS, BENT NEEDLE TIPS, IRRIGATION NEEDLE TIPS Dental Barriers & Sleeves MOUTHPIECE, SALIVA EJECTOR, PLASTIC TUBES, ASPIRATOR TIPS DENTAL ACCESSORIES,Oral cup,Water Bottle,Vacuum Canister,Mixing Tip,Plastic Boxes,Matrices,Aligner Seater,Connector Dam frame,overglove,Barrier apron,Waste bag,Inserts,Capsule applier,Brush handle& tips,Finger ruler,Matrix,Splash shield Foam insert,Cartridge connector,Syringe tips,Intraoral tip,Plug,Core Forms,Polishing item,Tube&Plug,Indicator tape&strip Traps,Wraps, Model cartridge,Model Former, Mixing well, Pouch, Dappen dishes, Plastic sterilization tubing, Spatula,Bowl EVACUATOR, ORAL CAVITY-EVACUATOR TIPS, HVE Tip Accessories, Adaptors GAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE-GAUZE/SPONGE, COTTON SPUNLACE SPONGES Non-Woven Isolation Gown & Accessories, Non-Surgical Isolation Gowns Tray Paper, Bib, Tissue Headrest Cover, Face & Chest Cover Dental Floss Plastic Film Holder,Bite Block,Film carrier,Barrier envelopes, Aligning system,Snap film holder,Sensor holder,Film Mount Tape, Measuring, Rulers & Calipers, Finger Ruler Cheek Retractors, Props, Retractor-all types Dental Mirror, Mouth Mirror, Photography Mirror, Photo Contrastor Cotton Tip Applicators, Micro Applicators, Applicator Tips, Microbrush Applicators Chair, Chair stools & accessories, plastic covers, plastic tubing & sleeves, barrier films, plastic bags Denture Cleanser

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2011-04-29
EFN	Cotton, Roll	Dental	Class 1	872.6050	2021-12-06
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2015-08-06
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	1998-10-07
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2025-06-05
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2014-05-05
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2017-08-25
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2011-04-29
ECB	Unit, Syringe, Air And/Or Water	Dental	Class 1	872.4565	2011-04-29
DZM	Needle, Dental	Dental	Class 1	872.4730	2016-04-01
PEM	Dental Barriers And Sleeves	General, Plastic Surgery	Class 2	878.4370	2020-12-31
DYN	Mouthpiece, Saliva Ejector	Dental	Class 1	872.6640	1994-06-28
NRD	Unit, Operative Dental, Accessories	Dental	Class 1	872.6640	2011-04-29
EHZ	Evacuator, Oral Cavity	Dental	Class 1	872.6640	2011-04-29
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2011-04-29
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2014-05-14
KHR	Absorber, Saliva, Paper	Dental	Class 1	872.6050	2011-04-29
JES	Floss, Dental	Dental	Class 1	872.6390	2014-05-05
EGZ	Holder, Film, X-Ray	Dental	Class 1	872.1905	2014-05-05
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2018-03-19
EIG	Retractor, All Types	Dental	Class 1	872.4565	2016-08-10
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2011-05-23
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2016-07-19
NRU	Chair, Dental, Without Operative Unit	Dental	Class 1	872.6250	2023-06-13
EFT	Cleanser, Denture, Over The Counter	Dental	Class 1	872.3520	2023-04-27

Official Correspondent

LARRY WEI

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PLASDENT CORP.

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
K201622	Guangdong Kingfa Sci. & Tech.Co., Ltd.	Medical surgical mask	2020-11-24
K881618	3M Company	ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK	1988-05-09
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11
K781592	Henry Schein, Inc.	SURGICAL ASPIRATOR TIPS	1978-12-04
K882164	Arthur Blank & Co., Inc.	FLOSS CARD	1988-06-10

Similar Registrations

Registration Number	Establishment Name	Location
3010622180	MEGA-PHYSIK Ges. fuer physikalische Messtechnik mbh Co KG	Rastatt Baden-Wurttemberg, DE
3009509745	DENT A PHARM PRODUKTIONSGESELLSCHAFT MBH	Barmstedt Schleswig-Holstein, DE
2411056	BUFFALO DENTAL MFG. CO., INC.	SYOSSET, NY, US
1417846	FRICKE DENTAL MFG. CO.	Streamwood, IL, US
3016447764	DSI DENTAL SOLUTIONS LTD	Ashdod Southern, IL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2029234. Last updated year: 2026. Please use registration number 2029234 when referencing this establishment in official correspondence.