Manufacturer registered with FDA
Life Science Outsourcing, Inc.
Brea, CA, United States. Lists 4 dental device types with FDA across 2 registered establishments.
- Device types listed
- 4
- Brands and models
- 28
- 510(k) clearances
- 0as applicant
- Markets registered in
- 519 registrations outside the US
- Establishments
- 2United States
Registered in 5 markets
Where regulators' registries name Life Science Outsourcing, Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Life Science Outsourcing, Inc. | 4 device types | — | Below |
| South Korea | MFDS | Manufacturer | Life Science Outsourcing, Inc.Life Science Outsourcing,Inc. | 13 | 2013–2023 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | LIFE SCIENCE OUTSOURCING, INC.LIFE SCIENCE OUTSOURCING | 4 | 2013–2015 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | LIFE SCIENCE OUTSOURCING, INC | 1 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | LIFE SCIENCE OUTSOURCING, INC. | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Life Science Outsourcing, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | 818-2131 Traverse Rotary Glide Path File - 6/.13/21mm - N818-2132 Traverse Rotary Glide Path File - 6/.13/25mm - N818-2133 Traverse Rotary Glide Path File - 6/.13/31mm - N818-2141 Traverse Orifice and Glide Path File - 6/.13/21mm - N818-2142 Traverse Orifice and Glide Path File - 6/.13/25mm - N818-2143 Traverse Orifice and Glide Path File - 6/.13/31mm - N818-2146 Traverse Orifice and Glide Path File - 6/.13/21mm - R818-2147 Traverse Orifice and Glide Path File - 6/.13/25mm - R818-2148 Traverse Orifice and Glide Path File - 6/.13/31mm - R818-2156 Traverse Rotary Glide Path File - 6/.13/21mm - R 16 more818-2157 Traverse Rotary Glide Path File - 6/.13/25mm - R818-2158 Traverse Rotary Glide Path File - 6/.13/31mm - R818-2181 Traverse Rotary Glide Path File - 6/.18/21mm - N818-2182 Traverse Rotary Glide Path File - 6/.18/25mm - N818-2183 Traverse Rotary Glide Path File - 6/.18/31mm - N818-2186 Traverse Rotary Glide Path File - 6/.18/21mm - R818-2187 Traverse Rotary Glide Path File - 6/.18/25mm - R818-2188 Traverse Rotary Glide Path File - 6/.18/31mm - R818-2191 Traverse Orifice and Glide Path File - 6/.18/21mm - N818-2192 Traverse Orifice and Glide Path File - 6/.18/25mm - N818-2193 Traverse Orifice and Glide Path File - 6/.18/31mm - N818-2196 Traverse Orifice and Glide Path File - 6/.18/21mm - R818-2197 Traverse Orifice and Glide Path File - 6/.18/25mm - R818-2198 Traverse Orifice and Glide Path File - 6/.18/31mm - R818-8251 Traverse Orifice Opener - 8/.25/17mm - N818-8256 Traverse Orifice Opener - 8/.25/17mm - R | 2019 |
| Anti-Snoring DeviceLRK · Class 2 | Anti-snoring & jaw-repositioning devices | Maker | Elevo Set Snoring Intervention Device | 2022 |
| Intraoral Synthetic BarrierNPK · Class 2 | Bone grafts & membranes | Maker | — | 2017 |
| Orthodontic Endosseous ImplantOAT · Class 2 | — | Lister | VectorTAS Mini Screw | 2015 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Life Science OutsourcingFDA reg. 1221051 | SOMERSWORTH, NH, United States | Contract manufacturer, Contract sterilizer |
| LIFE SCIENCE OUTSOURCING, INC.FDA reg. 2031093 | Brea, CA, United States | Contract manufacturer, Contract sterilizer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10024857, 10034516). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.