Data / Medical devices / United States / The Belport Company, Inc DBA Gingi-Pak

The Belport Company, Inc DBA Gingi-Pak: FDA-registered device maker in Camarillo, CA, United States, 15 510(k) clearances

Name: The Belport Company, Inc DBA Gingi-Pak FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

The Belport Company, Inc DBA Gingi-Pak is registered with the FDA (registration 2014676) in Camarillo, CA, United States. It lists 18 device types. The FDA files 15 510(k) clearances under its listings, the newest dated June 20, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 2014676
Address: 4825 Calle Alto, Camarillo, CA, United States, 93012
Owner or operator: The Belport Company, Inc. DBA Gingi-Pak (2014676)
Roles: Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
First device listed: November 30, 1992
Registered through: 2026
Brand names listed: 23985, Rodin Titan, Shade 0M3, 1.2kg/Bottle, 23986, Rodin Titan, Shade B1, 1.2kg/Bottle, 23987, Rodin Titan, Shade A1, 1.2kg/Bottle, 23988, Rodin Titan, Shade A2, 1.2kg/Bottle, 23989, Rodin Titan, Shade A3, 1.2kg/Bottle, 23990, Rodin Titan, Shade C2, 1.2kg/Bottle, 23991, Rodin Titan, Shade 0M3, 600g/Bottle, 23992, Rodin Titan, Shade B1, 600g/Bottle and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Implant, Dental, Endosseous	NDP	1	Manufacturer	accessdata.fda.gov
Agent, Tooth Bonding, Resin	KLE	2	Manufacturer	accessdata.fda.gov
Alloy, Metal, Base	EJH	2	Manufacturer	accessdata.fda.gov
Cord, Retraction	MVL	U	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Cotton, Roll	EFN	1	Repackager or relabeler	accessdata.fda.gov
Disinfectant, Medical Devices	LRJ	1	Manufacturer	accessdata.fda.gov
Floss, Dental	JES	1	Manufacturer	accessdata.fda.gov
Maintainer, Space Preformed, Orthodontic	DYT	1	Manufacturer	accessdata.fda.gov
Material, Impression	ELW	2	Manufacturer	accessdata.fda.gov
Material, Impression Tray, Resin	EBH	1	Manufacturer	accessdata.fda.gov
Material, Tooth Shade, Resin	EBF	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Needle, Dental	DZM	1	Repackager or relabeler, Specification developer	accessdata.fda.gov
Plate, Base, Shellac	EEA	1	Manufacturer	accessdata.fda.gov
Reagent, Occult Blood	KHE	2	Contract manufacturer	accessdata.fda.gov
Resin, Denture, Relining, Repairing, Rebasing	EBI	2	Manufacturer	accessdata.fda.gov
Retractor, All Types	EIG	1	Manufacturer	accessdata.fda.gov
Syringe, Restorative And Impression Material	EID	1	Repackager or relabeler, Specification developer	accessdata.fda.gov
Teeth, Artificial, Backing And Facing	ELK	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
June 20, 2024	K240688	RODIN Titan 3D Resin	EBI	Substantially Equivalent	Belport Company, Inc., Gingi-Pak	accessdata.fda.gov
March 14, 2022	K211420	Stasis Gel	MVL	Substantially Equivalent	Belport Company, Inc., Gingi-Pak	accessdata.fda.gov
January 10, 2022	K211419	Gingi-Aid Gel	MVL	Substantially Equivalent	Belport Company, Inc., Gingi-Pak	accessdata.fda.gov
July 26, 2021	K210412	Pac-Dent Ceramic Nanohybrid Resin	EBF	Substantially Equivalent	Pac-Dent, Inc.	accessdata.fda.gov
September 2, 2020	K200462	EtchPro Etching Gel	KLE	Substantially Equivalent	Belport Company, Inc., Gingi-Pak	accessdata.fda.gov
October 20, 2017	K162662	GingiDent Gingival Retraction Paste	MVL	Substantially Equivalent	Pac-Dent International, Inc.	accessdata.fda.gov
August 13, 2013	K130672	OPTIFLOW II FLOWABLE COMPOSITE, LC	EBF	Substantially Equivalent	Pac-Dent International, Inc.	accessdata.fda.gov
February 15, 2001	K010069	DURABOND NON-PRECIOUS CERAMIC ALLOY	EJH	Substantially Equivalent	Matech, Inc.	accessdata.fda.gov
December 13, 1999	K993572	CERADIUM V NON-PRECIOUS CERAMIC ALLOY	EJH	Substantially Equivalent	Matech, Inc.	accessdata.fda.gov
November 19, 1999	K992881	HI BOND NON-PRECIOUS CERAMIC ALLOY	EJH	Substantially Equivalent	Matech, Inc.	accessdata.fda.gov
September 22, 1999	K992705	CERADIUM NON-PRECIOUS CERAMIC ALLOY	EJH	Substantially Equivalent	Matech, Inc.	accessdata.fda.gov
February 12, 1998	K974894	KROMATICA COLOR CHANGING ALGINATE	ELW	Substantially Equivalent	Matech, Inc.	accessdata.fda.gov
January 21, 1994	K925746	REPLICA	ELW	Substantially Equivalent	Matech, Inc.	accessdata.fda.gov
February 22, 1982	K820061	REVERSIBLE HYDROCOLLOID IMPRESSION MAT	ELW	Substantially Equivalent	Belport Co., Inc.	accessdata.fda.gov
September 8, 1981	K812120	GINGI-PLAIN CORDS & BRAIDS	JES	Substantially Equivalent	Belport Co., Inc.	accessdata.fda.gov

Compare with other makers

Updated June 20, 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.