Data / Medical devices / Canada / Maxill, Inc.
Maxill, Inc.: FDA-registered device maker in ST. THOMAS Ontario, Canada, 15 510(k) clearances
Maxill, Inc. is registered with the FDA (registration 3005558160) in ST. THOMAS Ontario, Canada. It lists 39 device types. The FDA files 15 510(k) clearances under its listings, the newest dated April 23, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005558160
- Address
- 80 Elm ST., ST. THOMAS Ontario, Canada, N5R 6C8
- Owner or operator
- MAXILL INC. (9042210)
- Roles
- Exporter to the US, Foreign private label distributor, Manufacturer
- First device listed
- July 18, 2000
- Registered through
- 2026
- Brand names listed
- Cheek Retractors (Extraoral, Intraoral, Lip & Cheek, Single/Double Sided Hand Held), Covermax Head Rest Cover, Dental Wedges (Wooden, Plastic with Hole, Wedge Batons), Impression Tray (Dual-Arch, Krystal Klear, Classic, Anodonita, Orthodontic), MAXILL, MAXILL STERILIZATION TUBING, Maxill, Maxill Articulating Film and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Exporter to the US | accessdata.fda.gov |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | 1 | Exporter to the US | accessdata.fda.gov |
| Applicator, Resin | KXR | 1 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Bedding, Disposable, Medical | KME | 1 | Exporter to the US | accessdata.fda.gov |
| Cap, Surgical | FYF | 1 | Exporter to the US | accessdata.fda.gov |
| Cleaner, Ultrasonic, Medical Instrument | FLG | 1 | Manufacturer | accessdata.fda.gov |
| Cleanser, Denture, Over The Counter | EFT | 1 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Cotton, Roll | EFN | 1 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Cover, Shoe, Operating-Room | FXP | 1 | Exporter to the US | accessdata.fda.gov |
| Cup, Prophylaxis | EHK | 1 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Dam, Rubber | EIE | 1 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Floss, Dental | JES | 1 | Exporter to the US | accessdata.fda.gov |
| Gauze / Sponge,Nonresorbable For External Use | NAB | 1 | Exporter to the US | accessdata.fda.gov |
| Gutta-Percha | EKM | 1 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Handpiece, Contra- And Right-Angle Attachment, Dental | EGS | 1 | Exporter to the US | accessdata.fda.gov |
| Indicator, Physical/Chemical Sterilization Process | JOJ | 2 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Instruments, Dental Hand | DZN | 1 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Latex Patient Examination Glove | LYY | 1 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Material, Impression | ELW | 2 | Exporter to the US | accessdata.fda.gov |
| Mirror, Mouth | EAX | 1 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Paper, Articulation | EFH | 1 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Pick, Massaging | JET | 1 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Protector, Dental | BRW | 1 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Retractor, All Types | EIG | 1 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Scaler, Periodontic | EMN | 1 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Scraper, Tongue | LCN | 1 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Shield, Eye, Radiological | IWS | 1 | Exporter to the US | accessdata.fda.gov |
| Syringe, Restorative And Impression Material | EID | 1 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Toothbrush, Manual | EFW | 1 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Tray, Fluoride, Disposable | KMT | 1 | Exporter to the US | accessdata.fda.gov |
| Tray, Impression, Preformed | EHY | 1 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Unit, Operative Dental, Accessories | NRD | 1 | Exporter to the US | accessdata.fda.gov |
| Vinyl Patient Examination Glove | LYZ | 1 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Wax, Dental, Intraoral | EGD | 1 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Wheel, Polishing Agent | EJQ | 1 | Exporter to the US | accessdata.fda.gov |
| Wrap, Sterilization | FRG | 2 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 23, 2021 | K202462 | SIGMA Sterilization Pouch and Roll | FRG | Substantially Equivalent | Sigma Medical Supplies Corporation | accessdata.fda.gov |
| June 5, 2018 | K180661 | SIGMA Sterilization Pouch and Roll | FRG | Substantially Equivalent | Sigma Medical Supplies Corp. | accessdata.fda.gov |
| October 27, 2014 | K140940 | PROCESS INDICATOR TAPE FOR STEAM STERILIZATION | JOJ | Substantially Equivalent | Canadian Technical Tape, Ltd. | accessdata.fda.gov |
| August 2, 2011 | K102158 | SIGMA STERILIZATION POUCH & ROLL | FRG | Substantially Equivalent | Sigma Medical Supplies Corp. | accessdata.fda.gov |
| January 13, 2011 | K102836 | BONASIL A+ IMPRESSION MATERIALS | ELW | Substantially Equivalent | Dmp, Ltd. | accessdata.fda.gov |
| October 8, 2010 | K102161 | BLUE SAIL INNOVATION | LYZ | Substantially Equivalent | Shandong Blue Sail Innovation Co., Ltd. | accessdata.fda.gov |
| February 10, 2009 | K083624 | POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES | LZA | Substantially Equivalent | Comfort Rubber Gloves Ind. Sdn. Bhd. | accessdata.fda.gov |
| August 11, 2008 | K081633 | PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS | FXX | Substantially Equivalent | Primed Medical Products, Inc. | accessdata.fda.gov |
| March 20, 2007 | K063627 | POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE) | LZA | Substantially Equivalent | Smart Glove Corp. Sdn Bhd | accessdata.fda.gov |
| May 17, 2006 | K060724 | POWDER FREE NITRILE EXAMINATION GLOVE (BLACK AND GRAY) | LZA | Substantially Equivalent | Smart Glove Corp. Sdn Bhd | accessdata.fda.gov |
| June 3, 2004 | K040681 | SYNTHETIC (WHITE) VINYL PATIENT EXAMINATION GLOVES-POWDER FREE | LYZ | Substantially Equivalent | Grand Work Plastic Products Co., Ltd. | accessdata.fda.gov |
| April 27, 2004 | K040702 | SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES - POWDER FREE | LYZ | Substantially Equivalent | Grand Work Plastic Products Co., Ltd. | accessdata.fda.gov |
| January 8, 2004 | K033683 | SMART-FEEL POWDER FREE NITRILE EXAMINATION GLOVES PINK COLOR | LZA | Substantially Equivalent | Smart Glove Corp. Sdn Bhd | accessdata.fda.gov |
| October 31, 2001 | K012714 | ROYAL IMPERIAL POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR | LYY | Substantially Equivalent | Koon Seng Sdn Bhd | accessdata.fda.gov |
| May 16, 1994 | K941189 | DISPOSABLE PROPHYLAXIS ANGLE | EGS | Substantially Equivalent | Team Technologies, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Latex Patient Examination Glove
- All makers of Cleanser, Denture, Over The Counter
- All makers of Scaler, Periodontic
- All makers of Applicator, Absorbent Tipped, Non-Sterile
- All makers of Non-Surgical Gown
- All makers of Wrap, Sterilization
Updated April 23, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.