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METREX 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
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +18005377123
PRRC Contact: Jennifer Evans
EUDAMED SRN: US-MF-000043710
FDA FEI Number: 1000117344
DUNS Number: —

Catalogue (437)

Page 7 of 9

Device	Model / Reference	Registries	Class	Status
Allrap Protective Barriers	HRCS250C	FDA UDI	Class I	Active
HDL™ 4.5 Prism Plano - Dragonfly™	.HDL 4.5.TTL.DRAGONFLY * (GEN 2).*, Plano	FDA UDI	Class I	Active
PerfectPearl Brush	10-9524	FDA UDI	Class I	Active
Endeavour MD	910176-1	FDA UDI	Class I	Active
Orascoptic - Endeavour Headlight System	910119-3	FDA UDI	Class I	Active
Orascoptic - EyeZoom Max Rx	EyeZoom Max Rx	EUDAMEDFDA UDI	Class I	Active
Orascoptic - Endeavour XL Headlight System	910119-44	FDA UDI	Class I	Active
Pinnacle Cover-All	3715-CNC	FDA UDI	Class II	Active
Pinnacle Side Shields	4700C	FDA UDI	Class II	Active
Luxe™ 2.5 Semi-custom loupe	910165-3	FDA UDI	Class I	Active
Orascoptic - Dragonfly EyeZoom Max	Dragonfly EyeZoom Max	EUDAMEDFDA UDI	Class I	Active
OmniOptic™ Ocular Pair - HDL™ 5.5 Rx	.HDL 5.5.OMNI.OCULAR ONLY.*	EUDAMEDFDA UDI	Class I	Active
Luxe™ 2.5 Semi-custom loupe	910170-1	FDA UDI	Class I	Active
Orascoptic - Dragonfly EyeZoom Mini Rx	Dragonfly EyeZoom Mini Rx	EUDAMEDFDA UDI	Class I	Active
HDL™ Ergo 3.5 Rx - Dragonfly™	.HDL ERGO 3.5.TTL.DRAGONFLY * (GEN 2).*, Rx	FDA UDI	Class I	Active
Pinnacle Syringe Sleeve with Opening	3767-WOC	FDA UDI	Class II	Active
Safe-Tips EZ	44150C	FDA UDI	Class I	Active
Luxe™ 2.5 Semi-custom loupe	910166-2	FDA UDI	Class I	Active
Dispos-a-Bite	7000	FDA UDI	Class I	Active
Endeavour™ TruColor™	922010-3	FDA UDI	N/A	Active
Orascoptic - Dragonfly HDL 3.5 Galilean Rx	Dragonfly HDL 3.5 Galilean Rx	FDA UDI	Class I	Active
Orascoptic - Dragonfly HDL Ergo 3.5	Dragonfly HDL Ergo 3.5	EUDAMEDFDA UDI	Class I	Active
PerfectPearl Classic	10-9516	FDA UDI	Class I	Active
Orascoptic - Spark Headlight System	910118-1	FDA UDI	Class I	Active
HDL Ergo 5.0 Plano - Dragonfly	HDL Ergo 5.0 Plano - Dragonfly	EUDAMEDFDA UDI	Class I	Active
Orascoptic - Endeavour Headlight System	910119-1	FDA UDI	Class I	Active
EyeZoom™ Plano - Dragonfly™	.EYEZOOM.TTL.DRAGONFLY * (GEN 2).*, Plano	FDA UDI	Class I	Active
H.P. Sleeve	4000C	FDA UDI	Class II	Active
Petite Pearl	10-9531	FDA UDI	Class I	Active
Orascoptic - RDH Elite Rx	RDH Elite Rx	EUDAMEDFDA UDI	Class I	Active
Endeavour MD	910176-3	FDA UDI	Class I	Active
Orascoptic - Dragonfly RDH Ergo 3.0	Dragonfly RDH Ergo 3.0	EUDAMEDFDA UDI	Class I	Active
Orascoptic - EyeZoom Max Rx - XV1	EyeZoom Max Rx - XV1	FDA UDI	Class I	Active
Petite Pearl	10-9529	FDA UDI	Class I	Active
Orascoptic - Dragonfly HDL 3.5 Galilean	Dragonfly HDL 3.5 Galilean	FDA UDI	Class I	Active
Pinnacle Cure Sleeve	4500C	FDA UDI	Class II	Active
Pinnacle X-Ray Sensor Sheaths	PSS3340C	FDA UDI	Class II	Active
Orascoptic - Dragonfly HDL 3.0 Rx	Dragonfly HDL 3.0 Rx	EUDAMEDFDA UDI	Class I	Active
Orascoptic - Spark TruColor Headlight System	910133-32	FDA UDI	Class I	Active
Orascoptic - Dragonfly HDL 5.5	Dragonfly HDL 5.5	EUDAMEDFDA UDI	Class I	Active
Allrap Protective Barriers	XRS225C	FDA UDI	Class I	Active
Orascoptic - Endeavour Headlight System	910119-4	FDA UDI	Class I	Active
PerfectPearl Classic	10-9510C	FDA UDI	Class I	Active
Orascoptic - Dragonfly HDL 3.5 Rx	Dragonfly HDL 3.5 Rx	EUDAMEDFDA UDI	Class I	Active
Dispos-a-Bite	7060	FDA UDI	Class I	Active
CaviCide	13-1000	FDA UDI	Class I	Active
Orascoptic - Endeavour Headlight System	910119-5	FDA UDI	Class I	Active
RDH™ Ergo 3.0 Rx - Dragonfly™	.RDH ERGO 3.0.TTL.DRAGONFLY * (GEN 2).*, Rx	FDA UDI	Class I	Active
Petite Pearl	10-9528	FDA UDI	Class I	Active
Orascoptic - Orascoptic - HDL 2.5 Macro Rx	HDL 2.5 Macro Rx	FDA UDI	Class I	Unknown

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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).