Premium Plus (Dongguan) Limited
Manufacturer and brand owner in Dongguan, Guangdong, China. 34 device types, 13 products catalogued, 3 clearances.
Premium Plus (Dongguan) Limited is a repacker / relabeller holding a current FDA establishment registration. The registration covers Mirror, Mouth, Needle, Dental and 32 other device types. 13 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2024.
34device types registered with the FDA
13products catalogued under its own name
3510(k) clearances
Registration
| Registered name | PREMIUM PLUS (DONGGUAN) LIMITED |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3027234828 |
| FEI number | 3027234828 |
| DUNS | 541637603 |
| Establishment type | Repacker / relabeller, Manufacturer |
Chinese Registration
| Chinese legal name | 东莞佳特医疗器材有限公司 |
|---|---|
| Source | Baidu Baike |
Location
| City | Dongguan |
|---|---|
| Province | Guangdong |
| Address | Flat 101, No.122, Tianqiao Road, Changping |
| Postal code | 523581 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Absorber, Saliva, Paper | Class 1 | Tray papers, Dental bibs | 2024 | 86 |
| Accessory, Surgical Apparel | Class 1 | Face masks | 2024 | 439 |
| Activator, Ultraviolet, For Polymerization | Class 2 | Activator, for polymerization, Dental Curing Light | 2025 | 7 |
| Applicator, Resin | Class 1 | Brush applicator, brush tips, applicators, Micro Applicators | 2025 | 24 |
| Brush, Scrub, Operating-Room | Class 1 | Bur brush, brass/stainess steel wire brushes, aspirator brush | 2025 | 42 |
| Cannula, Surgical, General & Plastic Surgery | Class 1 | Surgical aspirator tips | 2024 | 14 |
| Chair, Dental, Without Operative Unit | Class 1 | Headrest Covers | 2025 | 38 |
| Cup, Prophylaxis | Class 1 | Disposable Prophy Brushes, Disposable Prophy Cups | 2024 | 49 |
| Dental Barriers And Sleeves | Class 2 | Curing Light Sleeves, Light Guide Sleeves, X-Ray Sensor Sleeves/ Mouth Mirror Sleeves, Impression Gun Sleeves, Instrument Tray Sleeves, instrument sleeves, Flowable Composite Syringe Sleeves, Intraoral Camera Sleeves and 10 more | 2024 | 12 |
| Evacuator, Oral Cavity | Class 1 | HVE Suction Tubes, Oral evacuators | 2024 | 49 |
| Frame, Rubber Dam | Class 1 | Rubber dam frame | 2024 | 7 |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | Endo sponges/cushions | 2024 | 266 |
| Handle, Instrument, Dental | Class 1 | Hand instruments, Plastic wedges | 2024 | 29 |
| Handpiece, Contra- And Right-Angle Attachment, Dental | Class 1 | Disposable Prophy Angles | 2025 | 9 |
| Holder, Film, X-Ray | Class 1 | Disposable peel-n-stick sensor holders, X-Ray Bite Cushions, Bite Wing Loops, X-Ray film holder, film clips | 2024 | 40 |
| Indicator, Physical/Chemical Sterilization Process | Class 2 | Sterilization pouches | 2024 | 19 |
| Instrument, Manual, Surgical, General Use | Class 1 | Dental instrument holder, Endo dispenser, Bur tray, Bur dispenser, Bur Block, Bur Stand, Endo Holder, Endo Organizer Box | 2024 | 110 |
| Instruments, Dental Hand | Class 1 | Composite syringe gun, composite syringe tips | 2025 | 64 |
| Mirror, Mouth | Class 1 | Mouth mirrors, Intraoral Mirrors | 2024 | 94 |
| Mixer, Cement, For Clinical Use | Class 1 | Dynamic Mixing Tips, Mixing cup, Mixing well, Mixing bowl, Dappen dish, Mixing ring | 2024 | 14 |
| Mouthpiece, Saliva Ejector | Class 1 | Saliva ejectors | 2024 | 68 |
| Needle, Dental | Class 1 | Applicator tips, Flowable composite and etching gel tips | 2025 | 56 |
| Retractor, All Types | Class 1 | Cheek retractor, mouth props, intraoral lippers | 2024 | 45 |
| Scraper, Tongue | Class 1 | Tongue cleaners | 2025 | 72 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Class 1 | Eye shield, Light shield | 2024 | 384 |
| Syringe, Restorative And Impression Material | Class 1 | Impression syringes,curved tip syringe, Intraoral Syringe Tips | 2024 | 49 |
| Tape, Measuring, Rulers And Calipers | Class 1 | Endo Measuring Blocks, Endo Rulers | 2025 | 42 |
| Toothbrush, Manual | Class 1 | interdental brush, brush | 2024 | 244 |
| Tray, Fluoride, Disposable | Class 1 | Fluoride trays | 2024 | 22 |
| Tray, Impression, Preformed | Class 1 | Impression trays, 3-IN-1 Trays | 2024 | 73 |
| Tray, Surgical, Instrument | Class 1 | Sterilisation Cassettes, Plastic trays, Tray racks, Instrument mats, Cabinet tray | 2024 | 105 |
| Unit, Operative Dental, Accessories | Class 1 | tooth fracture detector,spatula, napkin holders, instrument rings, mask extenders, Dental accessories, organisers, dispensers, holders, retainers, denture boxes | 2024 | 65 |
| Unit, Syringe, Air And/Or Water | Class 1 | air-water syringe tips, greenline syringe tips | 2025 | 56 |
| Wrap, Sterilization | Class 2 | Sterilization pouches | 2024 | 38 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Premium Plus | KXR | 68 |
| Premium Plus | PEM | 61 |
| Premium Plus | EHY | 54 |
| Premium Plus | LYU | 26 |
| Premium Plus | MDM | 23 |
| Premium Plus | DZM | 7 |
| Premium Plus | KMT | 6 |
| Premium Plus | HOY | 5 |
| Premium Plus | NRU | 4 |
| Premium Plus | EID | 4 |
| Premium Plus | NRD | 3 |
| Premium Plus | JDZ | 2 |
| Premium Plus | EGS | 2 |
Clearances
3 clearances name Premium Plus (Dongguan) Limited as applicant. 1 is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K251869 | 2025-09-15 | EGS | Traditional | This company |
| K250009 | 2025-04-10 | EBZ | Traditional | This company |
| K220662 | 2022-05-11 | PEM | Traditional | This company |
| K162258 | 2017-04-28 | FRG | Traditional | Tianchang Jiarui Packaging Material Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2002 |
|---|---|
| Factory area | 10000 sq m |
| Main products | Dental disposable products |
| Export markets | USA, Japan, UK |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.