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Sign in to claim this brandMETREX RESEARCH
United States·US-MF-000043710
Last updated September 17, 2026
What METREX RESEARCH makes
Metrex Research manufactures reusable surgical binoculars, including loupes and powered loupes for precision procedures, as well as general-purpose light sources like LED curing lights and headlight systems for surgical illumination. Their portfolio also includes single-use dental polishing cups, non-sterile instrument drapes, and protective covers for cables, leads, sensors, and probes. Additionally, they produce cleaning and disinfection wipes, disinfection agents, and decontamination agents for medical device reprocessing.
The company’s devices are classified under EU Medical Device Regulations as Class I and Class II, with corresponding FDA UDI listings. Their products are registered in the EU’s eudamed database and the FDA’s UDI system, reflecting compliance with regulatory requirements for both reusable and single-use medical instruments. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 28210, Wick Road, Romulus, United States
- Website
- www.kerrdental.com
- —
- —
- [email protected]
- Phone
- +18005377123
- PRRC Contact
- Jennifer Evans
- EUDAMED SRN
- US-MF-000043710
- FDA FEI Number
- 1000117344
- DUNS Number
- —
Catalogue (437)
Page 5 of 9| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| HDL™ 5.5 Prism Rx - Dragonfly™ | .HDL 5.5.TTL.DRAGONFLY * (GEN 2).*, Rx | FDA UDI | Class I | Active |
| Pinnacle Sensor Cover | 3735C | FDA UDI | Class II | Active |
| CaviWipes | 13-5155 | FDA UDI | Class I | Active |
| Orascoptic - HDL 3.5 Rx | HDL 3.5 Rx | EUDAMEDFDA UDI | Class I | Active |
| HDL™ 4.5 Plano - XV1™ | .HDL 4.5.TTL.XV1.*, Plano | FDA UDI | Class I | Active |
| Orascoptic - OmniOpti HDL 2.5 | OmniOpti HDL 2.5 | FDA UDI | Class I | Active |
| Orascoptic - HDL 3.5 Galilean | HDL 3.5 Galilean | FDA UDI | Class I | Active |
| Allrap Protective Barriers | TS115-16C | FDA UDI | Class I | Active |
| Orascoptic - EyeZoom Mini | EyeZoom Mini | EUDAMEDFDA UDI | Class I | Active |
| Orascoptic - RDH Ergo 3.0 | RDH Ergo 3.0 | EUDAMEDFDA UDI | Class I | Active |
| Endeavour™ XL | 910119-121 | FDA UDI | Class I | Active |
| Orascoptic - HDL 5.5 | HDL 5.5 | EUDAMEDFDA UDI | Class I | Active |
| Orascoptic - Dragonfly HDL 2.5 Micro | Dragonfly HDL 2.5 Micro | FDA UDI | Class I | Active |
| Orascoptic - Endeavour TruColor Headlight System | 910131-25 | FDA UDI | Class I | Active |
| Metricide | 10-602 | FDA UDI | Class II | Active |
| Orascoptic - EyeZoom | EyeZoom | FDA UDI | Class I | Active |
| HDL™ 2.5 Macro Plano - XV1™ | .HDL 2.5 MACRO.TTL.XV1.*, Plano | FDA UDI | Class I | Active |
| Allrap Protective Barriers | 460BC | FDA UDI | Class I | Active |
| EyeZoom™ Plano - XV1™ | .EYEZOOM.TTL.XV1.*, Plano | FDA UDI | Class I | Active |
| Orascoptic - Dragonfly HDL 2.5 Macro Rx | Dragonfly HDL 2.5 Macro Rx | EUDAMEDFDA UDI | Class I | Active |
| Spark TruColor | 910174-21 | FDA UDI | Class I | Active |
| Orascoptic - Endeavour Headlight System | 910119-7 | FDA UDI | Class I | Active |
| HDL™ 5.5 Prism Plano - Dragonfly™ | .HDL 5.5.TTL.DRAGONFLY * (GEN 2).*, Plano | FDA UDI | Class I | Active |
| CaviCide1 | 13-5025 | FDA UDI | Class I | Active |
| Luxe™ 2.5 Semi-custom loupe | 910165-1 | FDA UDI | Class I | Active |
| Pinnacle Chin Guard | 7200C | FDA UDI | Class II | Active |
| HDL™ 3.0 Rx - Dragonfly™ | .HDL 3.0.TTL.DRAGONFLY * (GEN 2).*, Rx | FDA UDI | Class I | Active |
| Orascoptic - Endeavour TruColor XL Headlight System | 910131-42 | FDA UDI | Class I | Active |
| Orascoptic - Spark TruColor Headlight System | 910133-22 | FDA UDI | Class I | Active |
| HDL Ergo 5.0 Rx - Dragonfly | HDL Ergo 5.0 Rx - Dragonfly | EUDAMEDFDA UDI | Class I | Active |
| Endeavour MD | 910175-2 | FDA UDI | Class I | Active |
| XV1™ / Dragonfly™ | 922122-1 | FDA UDI | N/A | Active |
| Orascoptic - Dragonfly EyeZoom Max Rx | Dragonfly EyeZoom Max Rx | EUDAMEDFDA UDI | Class I | Active |
| Orascoptic - Spark TruColor Headlight System | 910133-42 | FDA UDI | Class I | Active |
| Compliance | 10-2500 | FDA UDI | Class II | Active |
| Luxe™ 2.5 Semi-custom loupe | 922464-2 | FDA UDI | Class I | Active |
| CaviWipes HP | 16-1150 | FDA UDI | Class I | Active |
| Orascoptic - Safety Frame | Safety Frame | EUDAMEDFDA UDI | Class I | Active |
| Ball-Point Applicators | 8300-FC | FDA UDI | Class I | Active |
| Luxe™ 2.5 Semi-custom loupe | 910173-1 | FDA UDI | Class I | Active |
| Orascoptic - HDL Ergo 3.5 | HDL Ergo 3.5 | EUDAMEDFDA UDI | Class I | Active |
| Pinnacle X-Ray Sensor Sheath | PSS3100C | FDA UDI | Class II | Active |
| Pinnacle Drape-It-All | 3770C | FDA UDI | Class II | Active |
| ProCide-D | 10-2860 | FDA UDI | Class II | Active |
| HDL™ 3.5 Plano - XV1™ | .HDL 3.5.TTL.XV1.*, Plano | FDA UDI | Class I | Active |
| Pinnacle Complete Curing Light Sleeve | CLS250C | EUDAMEDFDA UDI | Class II | Active |
| Orascoptic - Endeavour TruColor XL Headlight System | 910131-50 | FDA UDI | Class I | Active |
| CaviCide1 | 13-5000 | FDA UDI | Class I | Active |
| Orascoptic - EyeZoom Mini Rx | EyeZoom Mini Rx | EUDAMEDFDA UDI | Class I | Active |
| CaviWipes1 | 13-5100 | FDA UDI | Class I | Active |
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FDA Recalls (3)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Metrex Research has three FDA recall records initiated between 2011-09-20 and 2017-01-20, all of which are marked as terminated. The recalls involved Cavicide with Spring Fresh Fragrance due to reported health reactions, Pinnacle Cure Sleeves with incorrect labeling for light guide compatibility, and CaviWipes Extra Large due to potential contamination during packaging.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jan 20, 2017 | Z-1402-2017 | — | terminated | Metrex is recalling the CaviWipes Extra Large because they may have been contaminated during the packaging process. |
| Feb 6, 2012 | Z-2267-2012 | — | terminated | 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. |
| Sep 20, 2011 | Z-0444-2013 | — | terminated | 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). |