Manufacturer registered with FDA
Garrison Dental Solutions LLC
Spring Lake, MI, United States. Lists 10 dental device types with FDA across 1 registered establishment, and holds 3 510(k) clearances as applicant.
- Device types listed
- 10
- Brands and models
- 33
- 510(k) clearances
- 32009–2024
- Markets registered in
- 1296 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2000–2026
Registered in 12 markets
Where regulators' registries name Garrison Dental Solutions 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 | Garrison Dental Solutions LLC | 3 clearances | 2009–2024 | Below |
| South Korea | MFDS | Manufacturer | Garrison Dental SolutionsGarrison Dental Solutions LLC | 18 | 2003–2017 | Pure Global AI |
| Australia | TGA | Manufacturer | Garrison Dental Solutions | 14 | 2008–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Garrison Dental Solutions LLC | 13 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | GARRISON DENTAL SOLUTIONS | 11 | 2005–2005 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | GARRISON DENTAL SOLUTIONS L.L.CGarrison Dental Solutions LLC | 10 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | GARRISON DENTAL SOLUTIONS, LLCGARRISON DENTAL SOLUTIONS · Garrison Dental Solutions, L.L.C. | 10 | 2009–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | GARRISON DENTAL SOLUTIONS LLCGARRISON DENTAL SOLUTIONS | 8 | 2006–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Garrison Dental Solutions LLC | 6 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | GARRISON DENTAL SOLUTIONS L.L.C. | 3 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Garrison Dental Solutions | 2 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | GARRISON DENTAL SOLUTIONS LLC | 1 | 2026–2026 | 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 Garrison Dental Solutions 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 |
|---|---|---|---|---|
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | A+ WedgeClearViewComposi-Tight®G WedgeNiTinWedge Wands®3D Fusion | 2004 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | LM Instruments, Reel Matrix | 2019 |
| Dental Diamond InstrumentDZP · Class 1 | Dental burs & diamonds | Maker | FitStrip | 2004 |
| Ultraviolet Activator for PolymerizationEBZ · Class 2 | Curing lights | Maker | LOOP LED Curing Light | 2025 |
| Abrasive DiskEHJ · Class 1 | Polishing & prophylaxis | Maker | Rally | 2016 |
| Abrasive PointEHL · Class 1 | Polishing & prophylaxis | Maker | eZrRally | 2014 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Maker | Composi-Tight®PerForm | 2006 |
| Rubber Dam Clamp ForcepsEJG · Class 1 | Rubber dam systems | Maker | Band and Wedge InstrumentComposi-Tight®NiTin3D Fusion | 2013 |
| Polishing Agent WheelEJQ · Class 1 | Polishing & prophylaxis | Maker | Rally | 2016 |
| Matrix RetainerJEP · Class 1 | Dental hand instruments | Maker | ClearViewComposi-Tight 3D Matrix SystemComposi-Tight 3DXR Matrix SystemComposi-Tight®FenderWedge®NiTinQuad Matrix SystemSilver PlusSlick BandsStrata-G Sectional Matrix System 3 moreVaristrip Matrix3D Clear Matrix3D Fusion | 1999 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Garrison Dental Solutions LLC as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 1 Aug 2024 | K241238 | LOOP LED Curing Light System (CLK01) | EBZ Ultraviolet Activator for Polymerization |
| 14 Aug 2020 | K200775 | LOOP LED Curing Light System | EBZ Ultraviolet Activator for Polymerization |
| 17 Aug 2009 | K091533 | SLICKS SECTIONAL MATRIX AND MATRIX BANDS, MODELS SM100, SM150, SM175, SM200, SM300, SMH100, SMH150, SMH175 AND SMH200 | JEP Matrix Retainer |
Also lists devices cleared under other names
Garrison Dental Solutions LLC lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Centrix, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 8 Jul 2014 | K140144 | BENDA WEDGE | Centrix, Inc. | EJB Dental Instrument Handle |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| GARRISON DENTAL SOLUTIONSFDA reg. 1836088 | Spring Lake, MI, United States | Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9036522). 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.