Manufacturer registered with FDA
Scapa Tapes North America LLC
Windsor, CT, United States. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 723 registrations outside the US
- Establishments
- 1United States
Registered in 7 markets
Where regulators' registries name Scapa Tapes North America LLC 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 | Scapa Tapes North America LLC | 1 device types | — | Below |
| Colombia | INVIMA | Manufacturer | SCAPA TAPES NORTH AMERICA, LLC | 13 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Scapa Tapes North America, LLCSCAPA TAPES NORTH AMERICA LTD | 5 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Scapa Tapes North America, LLC | 2 | 2020–2020 | Pure Global AI |
| Australia | TGA | Manufacturer | Scapa Tapes North America LLC | 1 | 2015–2015 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | SCAPA TAPES NORTH AMERICA LLC | 1 | 2008–2008 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Scapa Tapes North America LLC | 1 | 2009–2009 | 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 Scapa Tapes North America LLC currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Carboxymethylcellulose Sodium (32%) and Ethylene-Oxide Homopolymer Denture AdhesiveKOL · Class 1 | — | Maker | — | 2020 |
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 |
|---|---|---|
| Scapa Tapes North America, LLCFDA reg. 3015200795 | Knoxville, TN, United States | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9039148). 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.