Manufacturer registered with FDA
Glustitch, Inc.
Delta, Canada. Lists 1 dental device type with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 1
- Brands and models
- 10
- 510(k) clearances
- 22001–2007
- Markets registered in
- 1127 registrations outside the US
- Establishments
- 1Canada
510(k) clearances per year, 2000–2026
Registered in 11 markets
Where regulators' registries name Glustitch, 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 | Glustitch, Inc. | 2 clearances | 2001–2007 | Below |
| Canada | Health Canada | Registration holder | GLUSTITCH INC. | 6 | 1999–2007 | Pure Global AI |
| Israel | AMAR | Manufacturer | GluStitch Inc.GluStitch Incorporated | 5 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | GLUSTITCH INC.GluStitch Inc. | 5 | 2009–2022 | Pure Global AI |
| Colombia | INVIMA | Registration holder | GLUSTITCH INC.GLUSTITCH, INC | 3 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Glustitch Inc | 2 | 2013–2013 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | GluStitch Inc | 2 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | GluStitch Inc. | 1 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | GluStitch Inc. | 1 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Glustitch Inc. | 1 | 2022–2022 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | GluStitch 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 Glustitch, 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 |
|---|---|---|---|---|
| Dental CementEMA · Class 2 | Dental cements | Maker | PeriAcryl®90 P-ACRYL2(C)PeriAcryl®90 P-ACRYL2(V)PeriAcryl®90 P-ACRYL5(C)PeriAcryl®90 P-ACRYL5(V)PeriAcryl®90 P-ACRYL5(V)HVPeriAcryl®90 P-ACRYL9(V)PeriAcryl®90 P-ACRYL9(V)HVPeriAcryl®90 P-ACRYLU(C)PeriAcryl®90 P-ACRYLU(V)PeriAcryl®90 P-ACRYLU(V)HV | 2012 |
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 |
|---|---|---|
| GLUSTITCH, INC.FDA reg. 9615414 | Delta British Columbia, Canada | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9035904). 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.