Registered with FDA
Premium Plus Dental
Brooklyn, NY, United States. Lists 53 dental device types with FDA across 1 registered establishment.
- Device types listed
- 53
- Brands and models
- 63
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What Premium Plus Dental currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Lister | Stela Automix System | 2024 |
| Impression MaterialELW · Class 2 | Impression materials | Lister | MATERIAL IMPRESSION | 2025 |
| Dental CementEMA · Class 2 | Dental cements | Lister | CEMENT , DENTAL | 2025 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Lister | Agent, Tooth Bonding , ResinAGENT, TOOTH BONDING ,RESINStela Automix System | 2025 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Lister | — | 2025 |
| Teeth Plastic DentureELM · Class 2 | Denture resins & teeth | Lister | Denture, plastic teeth | 2025 |
| Saliva Ejector MouthpieceDYN · Class 1 | — | Lister | Premium Plus Saliva Ejector | 2007 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Lister | Premium Plus Dental Hand Instruments | 2010 |
| Dental Diamond InstrumentDZP · Class 1 | Dental burs & diamonds | Lister | PREMIUM PLUS | 2024 |
| Pulp TesterEAT · Class 2 | — | Lister | Premium Plus Dental Supplies Inc | 2017 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Lister | Premium Plus Mouth Mirrors | 2009 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Lister | — | 2025 |
| Retentive and Splinting Pin and Accessory InstrumentsEBL · Class 1 | — | Lister | — | 2025 |
| Ultraviolet Activator for PolymerizationEBZ · Class 2 | Curing lights | Lister | Premium Plus Led C02-C,C02-S, C02-DPremium Plus Led Curing Light C01Premium Plus Led Curing Light C01-C,C01-S, C01-DPremium Plus Led Curing Light C02 | 2017 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Lister | Premium Plius "a" Air Water Syringe TipsPremium Plus Clear Air/Water Syringe TipsPremium Plus e Air - Water Syringe Tips | 2005 |
| Orthodontic Wire ClampECN · Class 1 | — | Lister | Premium Plus Orthodontic Wire | 2009 |
| Rubber Dam ClampEEF · Class 1 | Rubber dam systems | Lister | CLAMP. RUBBER DAM | 2024 |
| Articulation PaperEFH · Class 1 | — | Lister | — | 2025 |
| Dental Dressing ForcepsEFL · Class 1 | Dental hand instruments | Lister | Nordent Dressing Pliers | 2026 |
| Roll CottonEFN · Class 1 | — | Lister | Premium Plus Cotton Rolls | 2010 |
| X-Ray Film HolderEGZ · Class 1 | — | Lister | Premium Plus X-Ray Film Holder | 2007 |
| Abrasive DiskEHJ · Class 1 | Polishing & prophylaxis | Lister | DISK ABRASIVE | 2025 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Lister | Densco Prophy Cups,BrushesPremium Plus Prophy Cups | 2007 |
| Abrasive PointEHL · Class 1 | Polishing & prophylaxis | Lister | House Brand Point AbrasiveMEISINGER Abrasives | 2009 |
| Polishing Agent StripEHM · Class 1 | Polishing & prophylaxis | Lister | — | 2025 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Lister | Premium Plus 3-IN-1 Trays with Wire ConnectorsPremium Plus Dental Plastic Cpated Metal Pliable Impression TraysPremium Plus Impression TraysPremium Plus Rim Lock Impression Trays | 2005 |
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Lister | Premium Plus Oral EvacuatorsPremium Plus Soft Touch | 2009 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Lister | Premium Plus Curved Tip SyringesPremium Plus Impression SyringePremium Plus Interoral Syringe TipsPremium Plus Mixer Cement Syringe Tips ,Mixing Well and Cups | 2005 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Lister | Premium Plus Mouth Retractors , Intraoral Lippers | 2010 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Lister | Premium Pl;us Mouth Retractor | 2007 |
| Periodontic ProbeEIX · Class 1 | Dental hand instruments | Lister | — | 2025 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Lister | INSTRUMENT, FILLING PLASTIC, DENTAL | 2024 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Lister | Dental Mixing Spatula and Mixing PadsPremium Plus Dental Disposable Napkin HolderPremium Plus Hand InstrumentsPremium Plus Micro Applicators | 2005 |
| Rubber Dam FrameEJE · Class 1 | Rubber dam systems | Lister | Premium Plus Rubber Dam Frame | 2007 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Lister | Premium Plus Orthodontic Bracket | 2009 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Lister | Premium Plus Polising Burs | 2009 |
| ArticulatorsEJP · Class 1 | Articulators & facebows | Lister | Premium Plus Dental Articulator | 2008 |
| Operative ExplorerEKB · Class 1 | Dental hand instruments | Lister | CX-1 Explorer, DG-16 Explorer | 2025 |
| Operative BurnisherEKJ · Class 1 | Dental hand instruments | Lister | AEI Burnishers | 2025 |
| Endodontic Root Canal PluggerEKR · Class 1 | Dental hand instruments | Lister | — | 2025 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Lister | Premium Plus Pulp Canal Instrument | 2009 |
| Preformed CrownELZ · Class 1 | — | Lister | — | 2025 |
| Surgical Rongeur ForcepsEMH · Class 1 | Dental hand instruments | Lister | Nordent Rongeur | 2026 |
| Dental Surgical ElevatorEMJ · Class 1 | Dental hand instruments | Lister | ELEVATOR, SURGICAL DENTALNordent Oral Surgery Elevators | 2024 |
| Dental Surgical CuretteEMK · Class 1 | Dental hand instruments | Lister | CURETTE,SURGICAL DENTAL | 2024 |
| Periodontic ScalerEMN · Class 1 | Dental hand instruments | Lister | — | 2025 |
| Periodontic CuretteEMS · Class 1 | Dental hand instruments | Lister | — | 2025 |
| Paper Saliva AbsorberKHR · Class 1 | — | Lister | Premium Plus Patient Bibs | 2010 |
| Root Canal Filling ResinKIF · Class 2 | Root canal filling materials | Lister | — | 2026 |
| Disposable Fluoride TrayKMT · Class 1 | — | Lister | Premium Plus Dluoride Trays Disposable | 2007 |
| Resin ApplicatorKXR · Class 1 | — | Lister | Premium Plus Brush ApplicatorsPremium Plus Micro Applicator | 2007 |
| Tongue ScraperLCN · Class 1 | — | Lister | Premium Plus Tongue Scraper | 2009 |
| Dental Chair without Operative UnitNRU · Class 1 | Dental chairs & operative units | Lister | Premium Plus Dental Supplies Inc | 2011 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Premium Plus Dental lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Sdi Limited (4), Shofu Inc (3), 3M Espe AG Dental Products (2), Voco GmbH (2), Southern Dental Industries, Inc. (2), 3M Company (2), DiaDent Group International (1), 3M Espe Dental Products (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 28 Oct 2022 | K222581 | Stela Automix System | Sdi Limited | EBF Resin Tooth Shade Material |
| 30 Aug 2022 | K214118 | Riva Cem Automix | Sdi Limited | EMA Dental Cement |
| 25 Jun 2020 | K200175 | DIA-ROOT BIO Sealer | DiaDent Group International | KIF Root Canal Filling Resin |
| 2 Dec 2019 | K191656 | Zipbond | Sdi Limited | KLE Resin Tooth Bonding Agent |
| 2 Jan 2019 | K183476 | 3M Filtek Universal Restorative | 3M Espe Dental Products | EBF Resin Tooth Shade Material |
| 22 Aug 2016 | K153514 | Premium Plus C01/C02 LED Curing Light | Premium Plus International Limited | EBZ Ultraviolet Activator for Polymerization |
| 27 Jul 2016 | K160596 | BEAUTIFIL II LS | Shofu Inc | EBF Resin Tooth Shade Material |
| 19 May 2011 | K110302 | ADHESIVE EXL-759 | 3M Espe AG | KLE Resin Tooth Bonding Agent |
| 8 Dec 2010 | K102984 | AURA | Sdi Limited | EBF Resin Tooth Shade Material |
| 23 Aug 2010 | K101603 | BEAUTIFIL FLOW PLUS | Shofu Inc | EBF Resin Tooth Shade Material |
| 8 Apr 2010 | K094007 | UNICEM | 3M Espe AG Dental Products | EMA Dental Cement |
| 15 Aug 2007 | K071742 | BEAUTIFIL II | Shofu Inc | EBF Resin Tooth Shade Material |
| 27 Jul 2005 | K051867 | GRANDIO | Voco GmbH | EBF Resin Tooth Shade Material |
| 7 Apr 2004 | K040769 | STRUCTUR 2 SC | Voco GmbH | EBG Resin Temporary Crown and Bridge |
| 11 Aug 2003 | K032001 | POLY Q (GARANT L, PENTA M, PENTA H) | 3M Espe AG Dental Products | ELW Impression Material |
| 22 Oct 2001 | K012528 | ICE | Southern Dental Industries, Inc. | EBF Resin Tooth Shade Material |
| 8 Dec 1997 | K973091 | WAVE | Southern Dental Industries, Inc. | EBF Resin Tooth Shade Material |
| 20 Mar 1992 | K920424 | SCOTCHBOND BRAND MULTI-PURPOSE ADHESIVE SYSTEM | 3M Company | KLE Resin Tooth Bonding Agent |
| 2 Mar 1992 | K914476 | VITAPAN ACRYLIC DENTURE TEETH | Vident | ELM Teeth Plastic Denture |
| 4 Oct 1991 | K913537 | MEMOSIL C.D. | Heraeus Kulzer, LLC | ELW Impression Material |
| 11 Aug 1988 | K882690 | IMPRINT VINYL POLYSILOXANE IMPRESSION MATERIAL | 3M Company | ELW Impression Material |
| 1 Mar 1988 | K875133 | CAVIT-W | Espe GmbH (Us) | EBG Resin Temporary Crown and Bridge |
| 31 Aug 1978 | K781151 | REPROSIL | Dentsply Intl., Inc. | ELW Impression Material |
| 28 Feb 1978 | K780301 | CAULK TYLOK | L.D. Caulk Co. | EMA Dental Cement |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| PREMIUM PLUS DENTAL SUPPLIES INCFDA reg. 3004425647 | BROOKLYN, NY, United States | Complaint file establishment |
Other names on FDA records
Premium Plus Dental Supplies Inc.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9070342). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.