This page includes the latest FDA filings for Westone Laboratories Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 2094377 |
| FEI Number | 2094377 |
| Name | WESTONE LABORATORIES, INC. |
| Owner & Operator | WESTONE LABORATORIES, INC. |
| Contact Address | 2235 EXECUTIVE CIRCLE Colorado Springs CO 80906 US |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 2235 Executive Cir Colorado Springs, CO 80906 US |
| Establishment Type |
|
Device Company | Device | Date |
|---|---|---|
| Westone Laboratories, Inc. | Impression Taking Traveler Kit International 10168 | 2023-09-04 |
| Westone Laboratories, Inc. | Impression Taking Traveler Kit 10166 | 2023-09-04 |
| Westone Laboratories, Inc. | Impression Taking Refill Kit International 10164 | 2023-09-04 |
| Westone Laboratories, Inc. | Impression Taking Starter Kit International 10163 | 2023-09-04 |
| Westone Laboratories, Inc. | Impression Taking Refill Kit 10162 | 2023-09-04 |
| Westone Laboratories, Inc. | Impression Taking Starter Kit 10161 | 2023-09-04 |
| Westone Laboratories, Inc. | Blue Silicast Hardener 10402 | 2023-09-04 |
| Westone Laboratories, Inc. | Blue Silicast 10401 | 2023-09-04 |
| Westone Laboratories, Inc. | EZ Mold 8oz Tub Set Forest Green 10391 | 2023-09-04 |
| Westone Laboratories, Inc. | EZ Mold 8oz Tub Set Red 10389 | 2023-09-04 |
| Westone Laboratories, Inc. | EZ Mold 8oz Tub Set Brown 10388 | 2023-09-04 |
| Westone Laboratories, Inc. | EZ Mold 8oz Tub Set Blue 10387 | 2023-09-04 |
| Westone Laboratories, Inc. | EZ Mold 8oz Tub Set Green 10386 | 2023-09-04 |
| Westone Laboratories, Inc. | EZ Mold 8oz Tub Set Yellow 10385 | 2023-09-04 |
| Westone Laboratories, Inc. | EZ Mold 8oz Tub Set Orange 10384 | 2023-09-04 |
| Westone Laboratories, Inc. | EZ Mold 8oz Tub Set Purple 10383 | 2023-09-04 |
| Westone Laboratories, Inc. | EZ Mold 8oz Tub Set Pink 10382 | 2023-09-04 |
| Westone Laboratories, Inc. | EZ Mold 8oz Tub Set Beige 10381 | 2023-09-04 |
| Westone Laboratories, Inc. | EZ Mold 8oz Tub Set Black 10380 | 2023-09-04 |
| Westone Laboratories, Inc. | EZ Mold Singles 22 Pk Assorted 10342 | 2023-09-04 |
| Westone Laboratories, Inc. | EZ Mold Singles 24 Pk Forest Green 10341 | 2023-09-04 |
| Westone Laboratories, Inc. | EZ Mold Singles 24 Pk Red 10339 | 2023-09-04 |
| Westone Laboratories, Inc. | EZ Mold Singles 24 Pk Brown 10338 | 2023-09-04 |
| Westone Laboratories, Inc. | EZ Mold Singles 24 Pk Blue 10337 | 2023-09-04 |
| Westone Laboratories, Inc. | EZ Mold Singles 24 Pk Green 10336 | 2023-09-04 |
| Westone Laboratories, Inc. | EZ Mold Singles 24 Pk Yellow 10335 | 2023-09-04 |
| Westone Laboratories, Inc. | EZ Mold Singles 24 Pk Orange 10334 | 2023-09-04 |
| Westone Laboratories, Inc. | EZ Mold Singles 24 Pk Purple 10333 | 2023-09-04 |
| Westone Laboratories, Inc. | EZ Mold Singles 24 Pk Pink | 2023-09-04 |
| Westone Laboratories, Inc. | EZ Mold Singles 24 Pk Beige 10331 | 2023-09-04 |
| Westone Laboratories, Inc. | EZ Mold Singles 24 Pk Black 10330 | 2023-09-04 |
| Westone Laboratories, Inc. | Pink Silicast 10302 | 2023-09-04 |
| Westone Laboratories, Inc. | Pink Silicast 10301 | 2023-09-04 |
| Westone Laboratories, Inc. | Silicone SINGLES 100 Pack 10205 | 2023-09-04 |
| Westone Laboratories, Inc. | Silicone SINGLES 24 Pack 10203 | 2023-09-04 |
| Westone Laboratories, Inc. | Oto-Ease Single Dose - 100/pk 54017 | 2023-03-10 |
| Westone Laboratories, Inc. | Oto-Ease 1/2-oz bottles 5/pk 54016 | 2023-03-10 |
| Westone Laboratories, Inc. | Oto-Ease 1/2oz bottle 1 pack 54015 | 2023-03-10 |
| Westone Laboratories, Inc. | Oto Ease 12pk Display Box 54011 | 2023-03-10 |
| Westone Laboratories, Inc. | SiliClone FIRM 8pk - 32 tips 10184 | 2022-12-07 |
| Westone Laboratories, Inc. | SiliClone FIRM 8pk - no tips 10183 | 2022-12-07 |
| Westone Laboratories, Inc. | SiliClone FIRM - 4 tips 10182 | 2022-12-07 |
| Westone Laboratories, Inc. | SiliClone S-50 8pk - 32 Tips 10154 | 2022-12-07 |
| Westone Laboratories, Inc. | SiliClone S-50 8pk - no tips 10153 | 2022-12-07 |
| Westone Laboratories, Inc. | SiliClone S-50 - 4 tips 10152 | 2022-12-07 |
| Westone Laboratories, Inc. | SiliClone S-50 - no tips 10151 | 2022-12-07 |
| Westone Laboratories, Inc. | SiliClone S-50 Starter Pack 10132 | 2022-12-07 |
| Westone Laboratories, Inc. | Siliclone X-Act 8pk 32 tips 10114 | 2022-12-07 |
| Westone Laboratories, Inc. | Siliclone X-Act 8pk No tips 10113 | 2022-12-07 |
| Westone Laboratories, Inc. | Siliclone X-Act with 4 Tips 10112 | 2022-12-07 |
WESTONE LABORATORIES, INC. | Oto-Ease | 2019-01-31 |
WESTONE LABORATORIES, INC. | Impression Material | 2017-11-27 |
WESTONE LABORATORIES, INC. | Protector, hearing (insert) | 2007-11-26 |
| NCAGE Code | 66DB7 | WESTONE LABORATORIES, INC. |
| NCAGE Code | 3T081 | WESTONE LABORATORIES, INC.!DBA WESTONE KALAMAZOO!DIV WESTONE LABS INC |
| CAGE Code | 3T081 | WESTONE LABORATORIES, INC. WESTONE KALAMAZOO WESTONE LABS INC |
| CAGE Code | 66DB7 | WESTONE LABORATORIES, INC. |
| S.A.M. Registration | 3T081 [7087497] | WESTONE LABORATORIES, INC. WESTONE KALAMAZOO |
| DUNS | 964788884 | WESTONE LABORATORIES, INC. |
| Import ID | Shipment | Cargo Description | Quantity |
|---|---|---|---|
| 2020042349378 | Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey | OTOPLASTIC PRODUCTSHS CODE 39100000 39069090 39069090 | 11 BOX |
| 2020032611536 | Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey | SILICONEHS CODE 39100000 39069090 90183110 . | 8 BOX |
| 2020032123038 | Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey | SILICONEHS CODE 39100000 39069090 90183110 . | 8 BOX |
| 2020031641261 | Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey | SILICONEHS CODE 39100000 39069090 90183110 . | 8 BOX |
| 2019101719825 | Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey | SILICONEHSCODE 39100000 . | 3 CTN |
| 2019100347336 | Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey | SILICONEHSCODE 39100000 . | 3 CTN |
| 2019100256542 | Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey | SILICONEHSCODE 39100000 . | 3 CTN |
| 2019052558427 | Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey | SILIKONEINCL IMDG 3 UN 1247 PG II FP 10 CELSIUSMETHYL METHACRYLATE MONOMER STABILIZED106 KGS BRT 04 KGS NETHSCODE 39100000 8479907039069090 90183110 | 6 CTN |