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WESTONE LABORATORIES, INC.

Last updated September 17, 2026

Information

Country: US
Address: 2260 Executive Cirle, Colorado Springs, CO, 80906
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 2094377
DUNS Number: —

Catalogue (50)

Device	Model / Reference	Registries	Class	Status
Blue Silicast Hardener	NA	FDA UDI	Class I	Active
EZ Mold Singles 24 Pk Green	NA	FDA UDI	Class I	Active
EZ Mold Singles 24 Pk Brown	NA	FDA UDI	Class I	Active
EZ Mold 8oz Tub Set Orange	NA	FDA UDI	Class I	Active
EZ Mold 8oz Tub Set Green	NA	FDA UDI	Class I	Active
EZ Mold 8oz Tub Set Forest Green	NA	FDA UDI	Class I	Active
Oto Ease 12pk Display Box	NA	FDA UDI	Class I	Unknown
SiliClone FIRM - 4 tips	NA	FDA UDI	N/A	Active
EZ Mold Singles 22 Pk Assorted	NA	FDA UDI	Class I	Active
EZ Mold 8oz Tub Set Brown	NA	FDA UDI	Class I	Active
SiliClone S-50 8pk - 32 Tips	NA	FDA UDI	N/A	Active
Blue Silicast	NA	FDA UDI	Class I	Active
SiliClone FIRM 8pk - 32 tips	NA	FDA UDI	N/A	Active
SiliClone S-50 - no tips	NA	FDA UDI	N/A	Active
EZ Mold Singles 24 Pk Blue	NA	FDA UDI	Class I	Active
Impression Taking Refill Kit	NA	FDA UDI	Class I	Active
EZ Mold 8oz Tub Set Purple	NA	FDA UDI	Class I	Active
EZ Mold 8oz Tub Set Yellow	NA	FDA UDI	Class I	Active
Siliclone X-Act 8pk 32 tips	NA	FDA UDI	N/A	Active
Oto-Ease 1/2-oz bottles 5/pk	NA	FDA UDI	Class I	Unknown
Oto-Ease 1/2oz bottle 1 pack	NA	FDA UDI	Class I	Unknown
Silicone SINGLES 100 Pack	NA	FDA UDI	Class I	Active
Impression Taking Starter Kit International	NA	FDA UDI	Class I	Active
SiliClone S-50 Starter Pack	NA	FDA UDI	N/A	Active
EZ Mold 8oz Tub Set Red	NA	FDA UDI	Class I	Active
Impression Taking Refill Kit International	NA	FDA UDI	Class I	Active
Silicone SINGLES 24 Pack	NA	FDA UDI	Class I	Active
EZ Mold Singles 24 Pk Forest Green	NA	FDA UDI	Class I	Active
EZ Mold Singles 24 Pk Black	NA	FDA UDI	Class I	Active
EZ Mold Singles 24 Pk Orange	NA	FDA UDI	Class I	Active
SiliClone S-50 8pk - no tips	NA	FDA UDI	N/A	Active
EZ Mold Singles 24 Pk Pink	NA	FDA UDI	Class I	Active
EZ Mold Singles 24 Pk Beige	NA	FDA UDI	Class I	Active
EZ Mold 8oz Tub Set Black	NA	FDA UDI	Class I	Active
EZ Mold 8oz Tub Set Beige	NA	FDA UDI	Class I	Active
EZ Mold 8oz Tub Set Blue	NA	FDA UDI	Class I	Active
Impression Taking Traveler Kit International	NA	FDA UDI	Class I	Active
Impression Taking Traveler Kit	NA	FDA UDI	Class I	Active
SiliClone FIRM 8pk - no tips	NA	FDA UDI	N/A	Active
SiliClone S-50 - 4 tips	NA	FDA UDI	N/A	Active
EZ Mold Singles 24 Pk Purple	NA	FDA UDI	Class I	Active
Siliclone X-Act 8pk No tips	NA	FDA UDI	N/A	Active
Siliclone X-Act with 4 Tips	NA	FDA UDI	N/A	Active
EZ Mold 8oz Tub Set Pink	NA	FDA UDI	Class I	Active
Pink Silicast	NA	FDA UDI	Class I	Active
Impression Taking Starter Kit	NA	FDA UDI	N/A	Active
EZ Mold Singles 24 Pk Red	NA	FDA UDI	Class I	Active
Oto-Ease Single Dose - 100/pk	NA	FDA UDI	Class I	Active
EZ Mold Singles 24 Pk Yellow	NA	FDA UDI	Class I	Active
Pink Silicast	NA	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

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Importers

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Notified Bodies

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Authorities

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FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jul 13, 2012	Z-2058-2012	—	terminated	Westone is recalling all Oto Ease ear lubricant in all packaging configurations and sizes due to potential microbial contamination of the product.