Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004425647

FEI Number

3004425647

Entity Name

PREMIUM PLUS DENTAL SUPPLIES INC

City/State/Country

BROOKLYN, NY, US

Establishment Address

155 Liberty Ave, BROOKLYN, NY 11212, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

PREMIUM PLUS DENTAL (Owner Number: 9070342)

Owner / Operator Contact Address

155 Liberty Ave., --, Brooklyn, NY 11212, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K101603

PMA Number

N/A

All Registered Proprietary Names

Premium Plus Orthodontic Wire Premium Plus Dental Supplies Inc Premium Plus Rim Lock Impression Trays Premium Plus 3-IN-1 Trays with Wire Connectors Premium Plus Impression Trays Premium Plus Dental Plastic Cpated Metal Pliable Impression Trays Premium Plus Surgical Hand Instrument Premium Plus Dental Needle Station AGENT, TOOTH BONDING ,RESIN Stela Automix System Premium Plus Dental Supplies Inc Premium Plus Micro Applicator Premium Plus Brush Applicators PREMIUM PLUS CLAMP. RUBBER DAM AEI Burnishers ELEVATOR, SURGICAL DENTAL Nordent Oral Surgery Elevators Premium Plus Patient Bibs CX-1 Explorer, DG-16 Explorer Premium Plus PC Mouse Sleeves Premium Plus Headrest Sleeves Small /Large Premium Plus Lab Transport Bags Premium Plus Pen Type Curing Light Sleeves Premium Plus PSP X-Ray Barrier Envelopes Premium Plus Bite Block Sleeves Premium Plus T Light Handle Sleeves Premium Plus Coiled Tubing Sleeves Premium Plus Impression Gun Sleeves Premium Plus Straight Tubing Sleeves Premium Plus Low Speed / Universal Sleeves Premium Plus HVE Suction Tube Sleeves Premium Plus Light Guide Sleeves, Small/Medium Premium Plus X-Ray Sensor Sleeves, Large/Medium,Small & X Small Premium Plus High Speed / Pen Sleeves Premium Plus X-Ray Sensor Sleeves Two Step Premium Plus X-Ray Head / Keyboard Sleeves Premium Plus ISO Tray Sleeves Premium Plus Full and Half Chair Sleeves Premium Plus Barrier Film Clear/Blue Premium Plus Intraoral Camera Sleeves Prenium Plus Tray Sleeves Standard 'B' / Mini Premium Plus T Light Handle Sleeves, U-shape Premium Plus Syringe Sleeves Premium Plus Curing Light Handle Sleeves Premium Plus Composite Syringe Sleeves Premium PlusTablet Sleeves CURETTE,SURGICAL DENTAL Denture, plastic teeth Premium Plus Retainer,Mouth Guard,All Guard and Denture Box Agent, Tooth Bonding , Resin Premium Plus Dental Hand Instruments MATERIAL IMPRESSION Premium Plus Pulp Canal Instrument Premium Plus Mouth Retractors , Intraoral Lippers Premium Plus Brushes Applicators Premium Pl;us Eye Shields, Protective Eyewears,Face Shields DISK ABRASIVE Premium Plus Dluoride Trays Disposable MEISINGER Abrasives House Brand Point Abrasive Premium Pl;us Mouth Retractor Nordent Dressing Pliers Premium Plus Mouth Mirrors Premium Plus Oral Evacuators Premium Plus Soft Touch Premium Plus Hand Instruments Premium Plus Micro Applicators Dental Mixing Spatula and Mixing Pads Premium Plus Dental Disposable Napkin Holder Premium Plus Tongue Scraper Premium Plus Dental Articulator Premium Plus Prophy Cups Densco Prophy Cups,Brushes Premium Plus Instrument Tray, Instrument Rack,Instrument Cabinet Premium Plus Rubber Dam Frame Premium Plus Orthodontic Bracket Premium Plus Polising Burs CEMENT , DENTAL Premium Plus Curved Tip Syringes Premium Plus Interoral Syringe Tips Premium Plus Impression Syringe Premium Plus Mixer Cement Syringe Tips ,Mixing Well and Cups Premium Plus Led Curing Light C01 Premium Plus Led Curing Light C02 Premium Plus Led C02-C,C02-S, C02-D Premium Plus Led Curing Light C01-C,C01-S, C01-D Premium Plus Clear Air/Water Syringe Tips Premium Plus e Air - Water Syringe Tips Premium Plius "a" Air Water Syringe Tips

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EBL	Pin, Retentive And Splinting, And Accessory Instruments	Dental	Class 1	872.3740	2025-01-02
ECN	Clamp, Wire, Orthodontic	Dental	Class 1	872.5410	2009-10-21
EAT	Tester, Pulp	Dental	Class 2	872.1720	2017-07-10
EHM	Strip, Polishing Agent	Dental	Class 1	872.6010	2025-01-02
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2026-05-12
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2026-05-12
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2026-05-12
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2005-09-20
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2026-04-02
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2010-12-07
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2025-05-21
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2025-01-02
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2025-01-02
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2026-04-02
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2026-02-13
EMN	Scaler, Periodontic	Dental	Class 1	872.4565	2025-11-24
NRU	Chair, Dental, Without Operative Unit	Dental	Class 1	872.6250	2011-01-19
KXR	Applicator, Resin	Dental	Class 1	872.3140	2007-12-05
DZP	Instrument, Diamond, Dental	Dental	Class 1	872.4535	2024-12-12
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2025-01-02
EEF	Clamp, Rubber Dam	Dental	Class 1	872.6300	2024-12-09
EKJ	Burnisher, Operative	Dental	Class 1	872.4565	2025-11-24
EMJ	Elevator, Surgical, Dental	Dental	Class 1	872.4565	2024-12-09
KHR	Absorber, Saliva, Paper	Dental	Class 1	872.6050	2010-07-01
EIX	Probe, Periodontic	Dental	Class 1	872.4565	2025-11-24
EKB	Explorer, Operative	Dental	Class 1	872.4565	2025-11-24
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2026-04-02
EMA	Cement, Dental	Dental	Class 2	872.3275	2026-04-02
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2026-05-12
PEM	Dental Barriers And Sleeves	General, Plastic Surgery	Class 2	878.4370	2017-07-10
EMS	Curette, Periodontic	Dental	Class 1	872.4565	2025-11-24
EMK	Curette, Surgical, Dental	Dental	Class 1	872.4565	2024-12-09
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2025-01-02
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2010-12-07
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2025-01-02
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2025-05-21
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2026-05-12
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2010-12-07
ELW	Material, Impression	Dental	Class 2	872.3660	2026-06-18
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2009-10-21
EIF	Accessories, Retractor, Dental	Dental	Class 1	872.4565	2010-12-07
GEC	Brush, Scrub, Operating-Room	General, Plastic Surgery	Class 1	878.4800	2010-12-07
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2010-12-07
EHJ	Disk, Abrasive	Dental	Class 1	872.6010	2025-05-21
KMT	Tray, Fluoride, Disposable	Dental	Class 1	872.6870	2007-12-05
EHL	Point, Abrasive	Dental	Class 1	872.6010	2009-10-21
EIG	Retractor, All Types	Dental	Class 1	872.4565	2007-12-05
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2025-11-26
ELZ	Crown, Preformed	Dental	Class 1	872.3330	2025-01-02
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2024-06-10
EMA	Cement, Dental	Dental	Class 2	872.3275	2026-04-17
EFL	Forceps, Dressing, Dental	Dental	Class 1	872.4565	2026-04-20
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2009-10-21
EHZ	Evacuator, Oral Cavity	Dental	Class 1	872.6640	2009-10-21
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2026-04-02
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2005-09-20
EFH	Paper, Articulation	Dental	Class 1	872.6140	2025-01-02
LCN	Scraper, Tongue	Dental	Class 1	872.6855	2009-10-21
EJP	Articulators	Dental	Class 1	872.3150	2008-11-20
ELW	Material, Impression	Dental	Class 2	872.3660	2025-11-24
EHK	Cup, Prophylaxis	Dental	Class 1	872.6290	2007-12-05
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2010-12-07
EJE	Frame, Rubber Dam	Dental	Class 1	872.6300	2007-12-05
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2009-10-21
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2026-04-02
EMA	Cement, Dental	Dental	Class 2	872.3275	2025-01-02
EJL	Bur, Dental	Dental	Class 1	872.3240	2009-10-21
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2025-01-02
EMA	Cement, Dental	Dental	Class 2	872.3275	2026-06-18
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2024-06-10
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2005-09-20
EBZ	Activator, Ultraviolet, For Polymerization	Dental	Class 2	872.6070	2017-07-10
ECB	Unit, Syringe, Air And/Or Water	Dental	Class 1	872.4565	2005-09-20
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2024-06-10

Official Correspondent

WOONMING MAK

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PREMIUM PLUS DENTAL

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
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12
K945777	Smiths Industries Medical Systems, Inc.	PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES	1994-12-22
K020499	Jeneric/Pentron, Inc.	BOND-3 ADHESIVE	2002-04-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004425647. Last updated year: 2026. Please use registration number 3004425647 when referencing this establishment in official correspondence.