Data / Medical devices / United States / Garreco, LLC

Garreco, LLC: FDA-registered device maker in Heber Springs, AR, United States, 10 510(k) clearances

Name: Garreco, LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Garreco, LLC is registered with the FDA (registration 3009426332) in Heber Springs, AR, United States. It lists 4 device types. The FDA files 10 510(k) clearances under its listings, the newest dated February 10, 2000. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3009426332
Address: 430 Hiram Road, Heber Springs, AR, United States, 72543
Owner or operator: Garreco, LLC. (10042968)
Roles: Manufacturer, Repackager or relabeler
First device listed: January 15, 2013
Registered through: 2026
Brand names listed: Garreco, Garreco Base Plate Wax Sheets All Season, Garreco Base Plate Wax Sheets Medium Hard, Garreco Base Plate Wax Sheets Medium Soft, PEMACO 2000 INTRAORAL DENTAL WAX, PEMACO 3000 INTRAORAL DENTAL WAX, PEMACO BITE BLOCK RODS-MEDIUM SOFT & MEDIUM HARD, PEMACO BITE WAX SHEETS and more

Devices it lists

Device	Product code	Class	Role	Source
Bur, Dental	EJL	1	Repackager or relabeler	accessdata.fda.gov
Material, Impression Tray, Resin	EBH	1	Repackager or relabeler	accessdata.fda.gov
Resin, Denture, Relining, Repairing, Rebasing	EBI	2	Repackager or relabeler	accessdata.fda.gov
Wax, Dental, Intraoral	EGD	1	Manufacturer	accessdata.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.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
February 10, 2000	K992176	EXCEL ULTRA-HI FORMULA HEAT-CURED DENTURE BASE MATERIAL	EBI	Substantially Equivalent	St. George Technology, Inc.	accessdata.fda.gov
February 2, 1995	K945711	EXCEL-P FORMULA AUTO-CURE DENTURE BASE	EBI	Substantially Equivalent	St. George Technology, Inc.	accessdata.fda.gov
January 18, 1994	K934019	EXCEL FORMULA HEAT-AUTO CURE DENT BASE/REPAIR/ORTHO	EBI	Substantially Equivalent	St. George Technology, Inc.	accessdata.fda.gov
August 21, 1991	K910676	INTRAORAL DENTAL WAX	EGD	Substantially Equivalent	Pemaco, Inc.	accessdata.fda.gov
November 6, 1989	K895566	PEMACO ECONOMY BASE PLATE WAX-MEDIUM SOFT	EGD	Substantially Equivalent	Pemaco, Inc.	accessdata.fda.gov
November 6, 1989	K895564	PEMACO BITE BLOCK RODS-MEDIUM SOFT & MEDIUM HARD	EGD	Substantially Equivalent	Pemaco, Inc.	accessdata.fda.gov
November 6, 1989	K895563	PEMACO BITE WAX SHEETS	EGD	Substantially Equivalent	Pemaco, Inc.	accessdata.fda.gov
November 6, 1989	K895562	PEMACO 2000 INTRAORAL DENTAL WAX	EGD	Substantially Equivalent	Pemaco, Inc.	accessdata.fda.gov
November 6, 1989	K895561	PEMACO 3000 INTRAORAL DENTAL WAX	EGD	Substantially Equivalent	Pemaco, Inc.	accessdata.fda.gov
October 24, 1989	K895565	PEMACO ECONOMY BASE PLATE WAX-MEDIUM HARD	EGD	Substantially Equivalent	Pemaco, Inc.	accessdata.fda.gov

Compare with other makers

Updated February 10, 2000. 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.