Data / Medical devices / United States / Metrex Research
Metrex Research: FDA-registered device maker in Romulus, MI, United States, 11 510(k) clearances
Metrex Research is registered with the FDA (registration 1722021) in Romulus, MI, United States. It lists 9 device types. The FDA files 11 510(k) clearances under its listings, the newest dated June 11, 2024. 3 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1722021
- FEI number
- 1000117344
- Address
- 28210 Wick RD., Romulus, MI, United States, 48174
- Owner or operator
- SYBRON DENTAL SPECIALTIES, INC. (9029565)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- November 17, 1992
- Registered through
- 2027
- Brand names listed
- ALLRAP CHAIR SLEEVE FULL SNG4556-75C, AP SLIP-N-GRIP SLEEVE UNIVERSAL SNG2980-75C, Allrap Protective Barriers, CHAIR SLEEVE HALF SGHC75C, CHAIR SLEEVE X-LONG SPECIAL GRIPPING PLASTIC PSCXL75C, CHAIR SLEEVE 32 x 32 PCS125C, CHAIR SLEEVE UNIVERSAL CHAIR COVER PCS150C, CaviCide and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Cleaning Brushes, For Endoscope | MNL | 1 | Manufacturer | accessdata.fda.gov |
| Aligner, Beam, X-Ray | EHA | 1 | Complaint file establishment | accessdata.fda.gov |
| Cover, Barrier, Protective | MMP | 2 | Complaint file establishment | accessdata.fda.gov |
| Disinfectant, Medical Devices | LRJ | 1 | Manufacturer | accessdata.fda.gov |
| Drape, Surgical, Exempt | PUI | 2 | Complaint file establishment | accessdata.fda.gov |
| Handpiece, Contra- And Right-Angle Attachment, Dental | EGS | 1 | Complaint file establishment | accessdata.fda.gov |
| Indicator, Physical/Chemical Sterilization Process | JOJ | 2 | Complaint file establishment | accessdata.fda.gov |
| Sterilant, Medical Devices | MED | 2 | Manufacturer | accessdata.fda.gov |
| Unit, Operative Dental | EIA | 1 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| June 11, 2024 | K241344 | MetriCide OPA Plus Solution Test Strip | JOJ | Substantially Equivalent | Steris | accessdata.fda.gov |
| August 19, 2014 | K140703 | OPA 30 SOLUTION | MED | Substantially Equivalent | Ciden Technologies, LLC | accessdata.fda.gov |
| April 14, 2003 | K030603 | PROANGLE DISPOSABLE PROPHY ANGLE | EGS | Substantially Equivalent | Pac-Dent International (Suzhou), Ltd. | accessdata.fda.gov |
| October 1, 2001 | K012335 | BROWNE METREX 1.8% GLUTARALDEHYDE INDICATOR FOR METRICIDE 28 AND METRICIDE PLUS 30 SOLUTIONS | JOJ | Substantially Equivalent | Albert Browne , Ltd. | accessdata.fda.gov |
| September 13, 1999 | K972708 | ENDO-SPOR PLUS / HYPROCIDE | MED | Substantially Equivalent | Cottrell, Ltd. | accessdata.fda.gov |
| January 30, 1997 | K962288 | COVER-ALL, DRAPE-IT-ALL, CHAIR SLEVE, X-RAY SLEEVE, HEADREST COVER | MMP | Substantially Equivalent | Pinnacle Products, Inc. | accessdata.fda.gov |
| May 23, 1995 | K951238 | SAFE-TIPS EZ | EIA | Substantially Equivalent | Safe Wave Products, Inc. | accessdata.fda.gov |
| December 6, 1994 | K931592 | METRICIDE PLUS 30 LIQUID CHEMICAL GERMICIDE | MED | Substantially Equivalent | Metrex Research Corp. | accessdata.fda.gov |
| December 6, 1994 | K931052 | METRICIDE 28 | MED | Substantially Equivalent | Metrex Research Corp. | accessdata.fda.gov |
| December 6, 1994 | K930284 | METRICIDE | MED | Substantially Equivalent | Metrex Research Corp. | accessdata.fda.gov |
| June 2, 1994 | K922481 | BROWNE GA INDICATOR USE IN 2% ACTIV GLUTARALDEHYDE | JOJ | Substantially Equivalent | Board of Directors, Albert Browne , Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 20, 2017 | 76318 | Class II | Terminated | CaviWipes1 Extra Large, Part No. 13-5150 The brand name of the device is CaviWipes1 Extra Large, a surface disinfectant. The device has been assigned the product code LRJ (General Purpose Disinfectant) by the FDA and is | Metrex is recalling the CaviWipes Extra Large because they may have been contaminated during the packaging process. | accessdata.fda.gov |
| February 6, 2012 | 62864 | Class II | Terminated | CaviCide, Part Numbers: 13-1025, 13-1000, 13-1024, MC-1000. Alternate brands: EnviroCide, part number: 13-3325. Private labeled products of Cavicide: Backscratchers Cavicide, part number: 13-4800. MaxiSpray Plus, part nu | Metrex Research is recalling Cavicide containing the Spring Fresh Fragrance because the affected lot of product containing this fragance has caused an increase in reported health reactions in some individuals such as headache, nausea, and respiratory discomfort. | accessdata.fda.gov |
| September 20, 2011 | 63583 | Class II | Terminated | Pentron Clinical Metrex Research; Pinnacle Cure Sleeve, a protective barrier The intended use of these devices is to protect both patient and healthcare worker from transfer of microorganisms, body fluids and particulate | The firm initiated the recall due to a labeling error. The boxes labeled as Pinnacle Cure Sleeve 4511, which fits 11mm light guides, actually contain Pinnacle Cure Sleeves that fit 7mm or 8mm light guides (part number 4500). | accessdata.fda.gov |
Compare with other makers
- All makers of Sterilant, Medical Devices
- All makers of Disinfectant, Medical Devices
- All makers of Indicator, Physical/Chemical Sterilization Process
- All makers of Cover, Barrier, Protective
- All makers of Drape, Surgical, Exempt
- All makers of Handpiece, Contra- And Right-Angle Attachment, Dental
Updated June 11, 2024. 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.