FDA Device Registration & Listing · Sunrise, FL, US · Registration 3009171220
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| KOP | Adhesive, Denture, Karaya | Dental | Class 1 | 872.3450 | 2015-01-07 |
| KOM | Adhesive, Denture, Acacia And Karaya With Sodium Borate | Dental | Class 1 | 872.3400 | 2015-01-07 |
| EBL | Pin, Retentive And Splinting, And Accessory Instruments | Dental | Class 1 | 872.3740 | 2015-01-06 |
| KCS | Pantograph | Dental | Class 1 | 872.3730 | 2015-01-07 |
| EFW | Toothbrush, Manual | Dental | Class 1 | 872.6855 | 2015-01-06 |
| EIR | Scissors, Collar And Crown | Dental | Class 1 | 872.4565 | 2015-01-06 |
| JET | Pick, Massaging | Dental | Class 1 | 872.6650 | 2015-01-07 |
| EGD | Wax, Dental, Intraoral | Dental | Class 1 | 872.6890 | 2015-01-06 |
| DYO | Band, Material, Orthodontic | Dental | Class 1 | 872.5410 | 2015-01-06 |
| EIG | Retractor, All Types | Dental | Class 1 | 872.4565 | 2015-01-06 |
| ECT | Driver, Band, Orthodontic | Dental | Class 1 | 872.4565 | 2015-01-06 |
| MMD | Toothbrush, Ionic, Battery-Powered | Dental | Class 1 | 872.6865 | 2015-01-07 |
| KME | Bedding, Disposable, Medical | General Hospital | Class 1 | 880.6060 | 2015-01-14 |
| EFC | Warmer, Anesthetic Tube | Dental | Class 1 | 872.6100 | 2015-01-06 |
| KGB | Mask, Oxygen, Non-Rebreathing | Anesthesiology | Class 1 | 868.5570 | 2015-01-14 |
| KOT | Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium | Dental | Class 1 | 872.3490 | 2015-01-07 |
| EKB | Explorer, Operative | Dental | Class 1 | 872.4565 | 2015-01-07 |
| KXW | Adhesive, Denture, Carboxymethylcellulose Sodium (49%) And Ethylene-Oxide Homopolymer | Dental | Class 1 | 872.3410 | 2015-01-07 |
| EKD | Instrument, Cutting, Operative | Dental | Class 1 | 872.4565 | 2015-01-07 |
| EMQ | Hoe, Periodontic | Dental | Class 1 | 872.4565 | 2015-01-07 |
| EAS | Gel, Electrode, For Pulp Tester | Dental | Class 1 | 872.1730 | 2015-01-06 |
| EHL | Point, Abrasive | Dental | Class 1 | 872.6010 | 2015-01-06 |
| KZO | Ink, Arch Tracing | Dental | Class 1 | 872.3150 | 2015-01-07 |
| FPO | Stretcher, Wheeled | General Hospital | Class 2 | 880.6910 | 2015-01-14 |
| FPP | Stretcher, Hand-Carried | General Hospital | Class 1 | 880.6900 | 2015-01-14 |
| EMG | Forceps, Tooth Extractor, Surgical | Dental | Class 1 | 872.4565 | 2015-01-07 |
| EGG | Attachment, Precision, All | Dental | Class 1 | 872.3165 | 2015-01-06 |
| EKE | Curette, Operative | Dental | Class 1 | 872.4565 | 2015-01-07 |
| EFN | Cotton, Roll | Dental | Class 1 | 872.6050 | 2015-01-06 |
| EEG | Heat Source For Bleaching Teeth | Dental | Class 1 | 872.6475 | 2015-01-06 |
| DYT | Maintainer, Space Preformed, Orthodontic | Dental | Class 1 | 872.5525 | 2015-01-06 |
| ELJ | Teeth, Artificial, Posterior With Metal Insert | Dental | Class 1 | 872.3900 | 2015-01-07 |
| DZM | Needle, Dental | Dental | Class 1 | 872.4730 | 2015-01-06 |
| ELR | Post, Root Canal | Dental | Class 1 | 872.3810 | 2015-01-07 |
| EMM | Chisel, Osteotome, Surgical | Dental | Class 1 | 872.4565 | 2015-01-07 |
| LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Clinical Chemistry | Class 1 | 862.2050 | 2018-08-06 |
| NFQ | Device, Dental Sonography, For Monitoring Jaw Sounds | Dental | Class 1 | 872.2050 | 2015-01-07 |
| KOO | Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt | Dental | Class 1 | 872.3490 | 2015-01-07 |
| EHY | Tray, Impression, Preformed | Dental | Class 1 | 872.6880 | 2015-01-06 |
| EJE | Frame, Rubber Dam | Dental | Class 1 | 872.6300 | 2015-01-07 |
| EJR | Agent, Polishing, Abrasive, Oral Cavity | Dental | Class 1 | 872.6030 | 2015-01-07 |
| EHO | Bar, Preformed | Dental | Class 1 | 872.3165 | 2015-01-06 |
| EBR | Unit, Suction Operatory | Dental | Class 1 | 872.6640 | 2015-01-06 |
| DZD | Tube, Orthodontic | Dental | Class 1 | 872.5410 | 2015-01-06 |
| EKH | Carver, Dental Amalgam, Operative | Dental | Class 1 | 872.4565 | 2015-01-07 |
| EJQ | Wheel, Polishing Agent | Dental | Class 1 | 872.6010 | 2015-01-07 |
| DZP | Instrument, Diamond, Dental | Dental | Class 1 | 872.4535 | 2015-01-06 |
| EJG | Forceps, Rubber Dam Clamp | Dental | Class 1 | 872.6300 | 2015-01-07 |
| ECB | Unit, Syringe, Air And/Or Water | Dental | Class 1 | 872.4565 | 2015-01-06 |
| EFK | Forceps, Articulation Paper | Dental | Class 1 | 872.4565 | 2015-01-06 |
| EHP | Clasp, Preformed | Dental | Class 1 | 872.3285 | 2015-01-06 |
| ECN | Clamp, Wire, Orthodontic | Dental | Class 1 | 872.5410 | 2015-01-06 |
| DZN | Instruments, Dental Hand | Dental | Class 1 | 872.4565 | 2015-01-06 |
| BYP | Mouthpiece, Breathing | Anesthesiology | Class 1 | 868.5620 | 2015-01-14 |
| EIE | Dam, Rubber | Dental | Class 1 | 872.6300 | 2015-01-06 |
| EGN | Scissors, Surgical Tissue, Dental | Dental | Class 1 | 872.4565 | 2015-01-06 |
| EMK | Curette, Surgical, Dental | Dental | Class 1 | 872.4565 | 2015-01-07 |
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | General, Plastic Surgery | Class 1 | 878.4680 | 2015-01-14 |
| JEX | Plier, Orthodontic | Dental | Class 1 | 872.4565 | 2015-01-07 |
| GAX | Tourniquet, Nonpneumatic | General, Plastic Surgery | Class 1 | 878.5900 | 2015-01-14 |
| EHK | Cup, Prophylaxis | Dental | Class 1 | 872.6290 | 2015-01-06 |
| EMJ | Elevator, Surgical, Dental | Dental | Class 1 | 872.4565 | 2015-01-07 |
| NKJ | Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter | Dental | Class 1 | 872.3540 | 2015-01-07 |
| EEA | Plate, Base, Shellac | Dental | Class 1 | 872.6200 | 2015-01-06 |
| EMD | Hemostat, Surgical | Dental | Class 1 | 872.4565 | 2015-01-07 |
| JES | Floss, Dental | Dental | Class 1 | 872.6390 | 2015-01-07 |
| EFS | Unit, Oral Irrigation | Dental | Class 1 | 872.6510 | 2015-01-06 |
| ECS | Pusher, Band, Orthodontic | Dental | Class 1 | 872.4565 | 2015-01-06 |
| NFS | Device, Jaw Tracking, For Monitoring Jaw Positions | Dental | Class 1 | 872.2060 | 2015-01-07 |
| EAZ | Light, Operating, Dental | Dental | Class 1 | 872.4630 | 2015-01-06 |
| EFT | Cleanser, Denture, Over The Counter | Dental | Class 1 | 872.3520 | 2015-01-06 |
| KCQ | Tube Impression And Matrix | Dental | Class 1 | 872.6570 | 2015-01-07 |
| EBH | Material, Impression Tray, Resin | Dental | Class 1 | 872.3670 | 2015-01-06 |
| EKS | File, Pulp Canal, Endodontic | Dental | Class 1 | 872.4565 | 2013-05-28 |
| ECI | Band, Elastic, Orthodontic | Dental | Class 1 | 872.5410 | 2015-01-06 |
| EAJ | Apron, Leaded | Radiology | Class 1 | 892.6500 | 2020-12-01 |
| KOQ | Adhesive, Denture, Carboxymethylcellulose Sodium (40-100&) | Dental | Class 1 | 872.3410 | 2015-01-07 |
| ECP | Instrument, Ligature Tucking, Orthodontic | Dental | Class 1 | 872.4565 | 2013-09-25 |
| DYN | Mouthpiece, Saliva Ejector | Dental | Class 1 | 872.6640 | 2015-01-06 |
| ELO | Cusp, Gold And Stainless Steel | Dental | Class 1 | 872.3350 | 2015-01-07 |
| DZC | Wire, Orthodontic | Dental | Class 1 | 872.5410 | 2014-12-29 |
| KMY | Positioner, Tooth, Preformed | Dental | Class 1 | 872.5525 | 2015-01-07 |
| ECR | Setter, Band, Orthodontic | Dental | Class 1 | 872.4565 | 2015-01-06 |
| EFH | Paper, Articulation | Dental | Class 1 | 872.6140 | 2015-01-06 |
| EMP | Marker, Periodontic | Dental | Class 1 | 872.4565 | 2015-01-07 |
| NDP | Accessories, Implant, Dental, Endosseous | Dental | Class 1 | 872.3980 | 2015-01-07 |
| EIY | Instrument, Filling, Plastic, Dental | Dental | Class 1 | 872.4565 | 2015-01-07 |
| NRU | Chair, Dental, Without Operative Unit | Dental | Class 1 | 872.6250 | 2015-01-07 |
| EMO | Knife, Periodontic | Dental | Class 1 | 872.4565 | 2015-01-07 |
| NOB | Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile | Dental | Class 1 | 872.6855 | 2015-01-07 |
| NUX | Cleanser, Denture, Prescription | Dental | Class 1 | 872.3520 | 2015-01-07 |
| KOL | Adhesive, Denture, Carboxymethylcellulose Sodium (32%) And Ethylene-Oxide Homopolymer | Dental | Class 1 | 872.3410 | 2015-01-07 |
| DZA | Drill, Dental, Intraoral | Dental | Class 1 | 872.4130 | 2015-01-06 |
| DYJ | Retainer, Screw Expansion, Orthodontic | Dental | Class 1 | 872.5410 | 2015-01-06 |
| ELA | Instrument, Hand, Calculus Removal | Dental | Class 1 | 872.4565 | 2015-01-07 |
| EIX | Probe, Periodontic | Dental | Class 1 | 872.4565 | 2015-01-07 |
| EJB | Handle, Instrument, Dental | Dental | Class 1 | 872.4565 | 2015-01-07 |
| EJF | Bracket, Metal, Orthodontic | Dental | Class 1 | 872.5410 | 2015-01-07 |
| EFX | Protector, Silicate | Dental | Class 1 | 872.6670 | 2015-01-06 |
| EKC | Excavator, Dental, Operative | Dental | Class 1 | 872.4565 | 2015-01-07 |
| MCF | Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Sterile | Dental | Class 1 | 872.6855 | 2015-01-07 |
| JEO | Measurer, Gingival Fluid | Dental | Class 1 | 872.1500 | 2015-01-07 |
| FQM | Bandage, Elastic | General Hospital | Class 1 | 880.5075 | 2015-01-14 |
| EKJ | Burnisher, Operative | Dental | Class 1 | 872.4565 | 2015-01-07 |
| IMD | Pack, Hot Or Cold, Disposable | Physical Medicine | Class 1 | 890.5710 | 2015-01-14 |
| JEP | Retainer, Matrix | Dental | Class 1 | 872.4565 | 2015-01-07 |
| KXR | Applicator, Resin | Dental | Class 1 | 872.3140 | 2015-01-07 |
| EKF | Instrument, Contouring, Matrix, Operative | Dental | Class 1 | 872.4565 | 2015-01-07 |
| EIK | Carver, Wax, Dental | Dental | Class 1 | 872.4565 | 2015-01-06 |
| EIS | Remover, Crown | Dental | Class 1 | 872.4565 | 2015-01-07 |
| ECO | Spring, Orthodontic | Dental | Class 1 | 872.5410 | 2015-01-06 |
| EIL | Gauge, Depth, Instrument, Dental | Dental | Class 1 | 872.4565 | 2015-01-06 |
| EJP | Articulators | Dental | Class 1 | 872.3150 | 2015-01-07 |
| EHE | Dispenser, Mercury And/Or Alloy | Dental | Class 1 | 872.3080 | 2015-01-06 |
| DZS | Capsule, Dental, Amalgam | Dental | Class 1 | 872.3110 | 2015-01-06 |
| EKG | Condenser, Amalgam And Foil, Operative | Dental | Class 1 | 872.4565 | 2015-01-07 |
| EMS | Curette, Periodontic | Dental | Class 1 | 872.4565 | 2015-01-07 |
| MAU | Eraser, Dental Stain | Dental | Class 1 | 872.6855 | 2015-01-07 |
| JER | Cleaner, Denture, Mechanical | Dental | Class 1 | 872.3530 | 2015-01-07 |
| EJX | Anchor, Preformed | Dental | Class 1 | 872.3130 | 2015-01-07 |
| EKA | File, Margin Finishing, Operative | Dental | Class 1 | 872.4565 | 2015-01-07 |
| EMI | File, Bone, Surgical | Dental | Class 1 | 872.4565 | 2015-01-07 |
| EJY | Pliers, Operative | Dental | Class 1 | 872.4565 | 2015-01-07 |
| MEF | Ring, Teething, Non-Fluid Filled | Dental | Class 1 | 872.5550 | 2015-01-07 |
| EKN | Point, Paper, Endodontic | Dental | Class 1 | 872.3830 | 2015-01-07 |
| ELK | Teeth, Artificial, Backing And Facing | Dental | Class 1 | 872.3910 | 2015-01-07 |
No US Agent registered (Local establishment).
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K973236 | Procter & Gamble Co. | CREST TOOTHBRUSH WITH MICROSHIELD | 1998-03-11 |
| K821629 | Moyco Industries, Inc. | FIXIDENT | 1982-06-14 |
| K884357 | Precision Dynamics Corp. | PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM | 1988-11-01 |
| K121698 | Dentsply International, Inc. | NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN | 2012-08-06 |
| K040797 | Britesmile, Inc. | BRITESMILE MASKING CREAM | 2004-04-02 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0023-05 | Stryker Medical | 2 | Stryker brand Rugged EZ-Pro R4 Ambulance Cot, model 6092. |
| Z-0002-2008 | Beckman Coulter Inc | 1 | FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use. |
| Z-0023-2013 | Biomerieux Inc | 1 | PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC.
Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples. |
| Z-0020-04 | Vital Concepts, Inc. | 1 | Huntington Instruments brand Irrigation Aspiration System with Single Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55040. Labeled as Manufactured for Huntington Instruments, Ogden Utah. |
| Z-0021-04 | Vital Concepts, Inc. | 1 | Irrigation Aspiration System with Double Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55060. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. Huntington Instruments brand labeled as Manufactured for Huntington Instruments, Ogden Utah. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ. Catalogue # 55060-10 sold in Canada and labeled as Manufactured for Jac-Cell Medic, Dorval, Quebec. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3006237499 | MODERN ORTHODONTICS | LUDHIANA, PUNJAB, IN |
| 3017953780 | WUHU GULI ORTHO CO.,LTD | Wuhu Anhui, CN |
| 3010002722 | Keystone Industries - Gibbstown | Gibbstown, NJ, US |
| 3043303267 | ONE DAY DENTAL PARTNER | Suncheon-si Jeonnam, KR |
| 3015548849 | Changsha Easyinsmile Intelligence Technology Co.Ltd. | Changsha Hunan, CN |
3009171220 when referencing this establishment in official correspondence.