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Data / Medical devices / United States / Garrison Dental Solutions

Garrison Dental Solutions: FDA-registered device maker in Spring Lake, MI, United States, 2 510(k) clearances

Garrison Dental Solutions is registered with the FDA (registration 1836088) in Spring Lake, MI, United States. It lists 10 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 1, 2024. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

FDA registration number
1836088
FEI number
3001422020
Address
150 Dewitt Ln, Spring Lake, MI, United States, 49456
Owner or operator
Garrison Dental Solutions LLC (9036522)
Roles
Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer
First device listed
February 19, 1999
Registered through
2026
Brand names listed
3D Clear Matrix, 3D Fusion, 3D Fusion™, A+ Wedge™, Band and Wedge Instrument, ClearView, Composi-Tight™ 3D Matrix System, Composi-Tight™ 3DXR Matrix System and more

Devices it lists

DeviceProduct codeClassRoleSource
Activator, Ultraviolet, For PolymerizationEBZ2Complaint file establishment, Specification developeraccessdata.fda.gov
Disk, AbrasiveEHJ1Complaint file establishment, Manufactureraccessdata.fda.gov
Forceps, Rubber Dam ClampEJG1Complaint file establishment, Specification developeraccessdata.fda.gov
Handle, Instrument, DentalEJB1Complaint file establishment, Specification developeraccessdata.fda.gov
Instrument, Diamond, DentalDZP1Complaint file establishment, Specification developeraccessdata.fda.gov
Instrument, Filling, Plastic, DentalEIY1Complaint file establishment, Contract manufacturer, Specification developeraccessdata.fda.gov
Instruments, Dental HandDZN1Complaint file establishment, Specification developeraccessdata.fda.gov
Point, AbrasiveEHL1Complaint file establishment, Specification developeraccessdata.fda.gov
Retainer, MatrixJEP1Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Wheel, Polishing AgentEJQ1Complaint file establishment, Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
August 1, 2024K241238LOOP™ LED Curing Light System (CLK01)EBZSubstantially EquivalentGarrison Dental Solutions, LLCaccessdata.fda.gov
July 8, 2014K140144BENDA WEDGEEJBSubstantially EquivalentCentrix, Inc.accessdata.fda.gov

Compare with other makers

Updated August 1, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.