Bioimaging and radiotherapy instrumentsDiagnostic and interventional radiology instrumentsInstruments for endoral radiology
Instruments for digital endoral radiology - consumables
EMDN code Z11030485
Manufacturers registered in Europe (EUDAMED) 1
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
- Click a manufacturer to see its full range, a model to open its EUDAMED record.
| Manufacturer | Country | Registered models | Class | Contact |
|---|---|---|---|---|
| PaloDEx Group FDA | Finland | I MDR | regulatory@dexis.com EUDAMED record Report an error |
A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.
Other manufacturers known in the United States (FDA) 62
Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.
| Manufacturer | Country | Brands | FDA clearance |
|---|---|---|---|
| PLASDENT CORPORATION | United States | Plasdent | K201604 (2020) |
| Premium Plus International Limited | China | Premium Plus PEARSON SOLEIL | K163447 (2017) |
| Premium Plus (Dongguan) Limited | China | Premium Plus | K220662 (2022) |
| JMU DENTAL, INC | – | JMU | registered |
| Dentsply Professional | – | Disposa-Shield® Sani-Tip® DELTON® Nupro MIDWEST® Sani-Shield® | registered |
| CARGUS INTERNATIONAL, INC | – | MARK3 | registered |
| Dental Health Products Inc | – | Health-Tec/DHP Barrier Products Health-Tec Barrier Film Health-Tec/DHP Headrest Covers Health-Tec Tray Sleeves Health-Tec Ultra Digital X-Ray Sensor Sheaths Health-Tec Air/Water Syringe Sleeves | registered |
| Dentsply Intl. Present in Europe in other categories | United States | digit Power® Dispenser SmartLite® Pro RINN® | K160232 (2016) |
| TIDI PRODUCTS, LLC | United States | TIDISHIELD VALO Carina | K132953 (2014) |
| Ismile Dental Products, Inc. | – | iSmile | registered |
| MAXILL, INC. | United States | PHOSPHOR PLATE BARRIER ENVELOPES POLYALL CURING LIGHT SLEEVE | registered |
| AMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC. | – | Patient Armor Barriers Amtouch Barrier Envelopes | registered |
| HENRY SCHEIN, INC. Present in Europe in other categories | United States | Henry Schein Henry Schein Essentials Acclean | registered |
| Air Techniques, Inc. Present in Europe in other categories | United States | ScanX Barrier Envelopes | K190949 (2019) |
| BENCO DENTAL SUPPLY CO. | – | BENCO SOLEIL | registered |
| Minitube AB | Sweden | OptiClear Sleeves MIXPAC Protective Sleeve VALO™ Barrier Sleeves C20 Intraoral Protective Sheaths OdneClean | K211026 (2021) |
| SCOTT'S DENTAL SUPPLY L.L.C. | – | SCOTT'S X-RAY SLEEVES 15" x 26" SMALL (250/bx) SCOTT'S HIGHSPEED HP SLEEVE 1" x 8" 500/bx SCOTT'S HEADREST CVR STD 9.5" X 11" (250) SCOTT'S FULL CHAIR COVER 29" X 80" (125/bx) SCOTT'S SYRINGE SLEEVE 2.5"x10" (500) BLUE SCOTT'S UNIV BARRIER FILM 4" X 6" BLUE | registered |
| DARBY DENTAL SUPPLY, LLC | – | Darby Dental Supply, LLC | registered |
| PRACTICON, INC. | United States | QUIKsheath Barriers T-Bar Light Handle QUIKsheath Barriers Large Digital X-Ray Sensor PRACTIfilm Barrier Cling Sheets Blue PRACTIfilm Barrier Cling Sheets Clear QUIKsheath Barriers Air-Water Syringe QUIKsheath Barriers Small Digital X-ray Sensor | registered |
| The Atlanta Dental Supply Company | – | Advance Dental Products | registered |
| ICP, INC. | United States | Dental City | registered |
| Dental Basics Inc. | – | Dental Basics | registered |
| Dukal LLC | United States | Unipack Dukal | registered |
| SAFCO DENTAL SUPPLY CO. | United States | Safco SafeWrap Chair Sleeves Safco SafeWrap Curing Light Sleeves Safco Safewrap syringe Safco SafeWrap Basics Syringe Sleeves Safco SafeWrap Tray Sleeves | registered |
| SIRONA DENTAL, INC. | – | XIOS XG XIOS SCHICK | registered |
| PREMIER DENTAL PRODUCTS COMPANY | United States | Sleeve-It AeroPro Barriers | registered |
| YOUNG DENTAL MANUFACTURING I, LLC | – | Denticator Narrow Scaler Sleeve | registered |
| Young Innovations, Inc. | United States | Defend Young Infinity | registered |
| BURKHART DENTAL SUPPLY CO., THE | – | Burkhart Chair Sleeve Full 29" x 80" (125) Burkhart Chair Cover Plastic 27" x 24" (225) Burkhart Tray Sleeve Size F 11-1/2 x 10-1/2 (500) Burkhart Tray Sleeve A 11 5/8 X 14 1/2 (500) | registered |
| IVOCLAR VIVADENT AKTIENGESELLSCHAFT | – | BLUEPHASE SLEEVES VivaPen Sleeves | registered |
| ULTRADENT PRODUCTS, INC. Present in Europe in other categories | United States | VALO VALO GRAND Ultrapro TX Cordless | registered |
| AMD Medicom Inc | Canada | Elements by Hedy Barrier Envelopes | registered |
| PURELIFE, LLC | – | PureLife+ CSR Wrap | registered |
| TOP QUALITY MANUFACTURING, INC. | – | Top Quality Manufacturing Barrier Film Top Quality Manufacturing Half Chair Sleeves | registered |
| DÜRR DENTAL SE Present in Europe in other categories | Germany | ScanX Barrier Envelope, 300 Pcs, Size 2 ScanX Barrier Envelope, 100 Pcs, Size 0 | K262073 (2026) |
| HU-FRIEDY MFG. CO., LLC | United States | Hu-Friedy | registered |
| R.G. ENTERPRISES (U.S.A.), INC. | United States | Geratherm Thermometer Sheaths | registered |
| TULSA DENTAL PRODUCTS LLC | United States | X-Smart | registered |
| UNIPACK MEDICAL CORPORATION | United States | Unipack | K183263 (2019) |
| VOCO GmbH Present in Europe in other categories | Germany | VisCalor Dispenser | registered |
| ZYRIS, INC. | – | Barrier Sleeve | registered |
| ANI Co., Ltd. | South Korea | – | K261956 (2026) |
| Bh Medical Products Co., Ltd. | China | – | K190484 (2019) |
| DENTSPLY SIRONA INC | United States | – | registered |
| Dongguan Wanjin Industrial Co., Ltd | China | – | registered |
| Duerr Dental AG Present in Europe in other categories | Germany | – | registered |
| Fomed Industries, Inc. | China | – | K250735 (2025) |
| Hubei Guarddent Medical Technology Co.,Ltd | China | – | registered |
| Ivoclar Vivadent, Inc. Present in Europe in other categories | United States | – | K191448 (2019) |
| Jinyuan medical equipment(tianjin)co.,ltd | China | – | registered |
| Kulzer, Inc. | United States | – | registered |
| MACO BAG CORP. | United States | – | registered |
| MouthWatch, LLC | United States | – | registered |
| NuCare LLC | United States | – | registered |
| Pac-Dent Inc. | United States | – | K151123 (2016) |
| READY SET IMPORT dba Mynt Professional | United States | – | registered |
| TIANJIN WATER SOURCE TECH CO., LTD | China | – | registered |
| Wellmed Dental Medical Supply Co., Ltd. | China | – | K242435 (2024) |
| Yizur Ltd | Hong Kong SAR China | – | registered |
| Yongqing Huaguan Dental Instruments Factory | China | – | K233918 (2024) |
| Yueying Medical Instruments (Langfang) Co., Ltd. | China | – | K250606 (2025) |
| Zapalign Inc. | South Korea | – | registered |
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Related categories
- Endoral radiology equipment28 manufacturers
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- Instruments for endoral radiology - consumables2 manufacturers
- Instruments for digital endoral radiology - medical device software1 manufacturer
- Parent category : Instruments for endoral radiology50 manufacturers