Data / Medical devices / United States / Pascal International, Inc.

Pascal International, Inc.: FDA-registered device maker in Bellevue, WA, United States, 2 510(k) clearances

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

Pascal International, Inc. is registered with the FDA (registration 3011632) in Bellevue, WA, United States. It lists 17 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 27, 2003. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3011632
Address: 2929 Northup Way, Bellevue, WA, United States, 98004
Owner or operator: Pascal International (3011632)
Roles: Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
First device listed: September 27, 1983
Registered through: 2026
Brand names listed: , R-50, 101, BK Probe, Banicide Advanced, Black Retrax System R-101, Black Retrax System R-11, Black Retrax System R-50, Black Retrax System R-55 and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Retractor, Dental	EIF	1	Repackager or relabeler, Specification developer	accessdata.fda.gov
Agent, Polishing, Abrasive, Oral Cavity	EJR	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Applicator, Absorbent Tipped, Non-Sterile	KXF	1	Repackager or relabeler	accessdata.fda.gov
Carver, Wax, Dental	EIK	1	Specification developer	accessdata.fda.gov
Cleaner, Ultrasonic, Medical Instrument	FLG	1	Manufacturer	accessdata.fda.gov
Cord, Retraction	MVL	U	Contract manufacturer, Manufacturer	accessdata.fda.gov
Cotton, Roll	EFN	1	Repackager or relabeler	accessdata.fda.gov
Cup, Prophylaxis	EHK	1	Repackager or relabeler	accessdata.fda.gov
Evacuator, Oral Cavity	EHZ	1	Repackager or relabeler	accessdata.fda.gov
Forceps, Articulation Paper	EFK	1	Repackager or relabeler	accessdata.fda.gov
Handle, Instrument, Dental	EJB	1	Repackager or relabeler	accessdata.fda.gov
Instruments, Dental Hand	DZN	1	Manufacturer	accessdata.fda.gov
Mirror, Mouth	EAX	1	Specification developer	accessdata.fda.gov
Paper, Articulation	EFH	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Sterilant, Medical Devices	MED	2	Manufacturer	accessdata.fda.gov
Tray, Fluoride, Disposable	KMT	1	Repackager or relabeler	accessdata.fda.gov
Varnish, Cavity	LBH	2	Manufacturer, Repackager or relabeler	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
May 27, 2003	K012889	BANICIDE LIQUID CHEMICAL STERILANT/HIGH-LEVEL DISINFECTANT	MED	Substantially Equivalent	Pascal Co., Inc.	accessdata.fda.gov
May 2, 2003	K030488	FLUORILAQ	LBH	Substantially Equivalent	Pascal Co., Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
August 9, 2005	32900	Not yet classified	Terminated	product labeled in part: ''*banicide ADVANCED, A Reusable Sterilizing & Disinfecting SolutionActive Ingredient: Glutaraldehyde (1,5 Pentanedial) 3.5%NET CONTENTS: 3.8l (ONE U.S. GALLON)*Manufactured by Pascal C	The product, Banicide Advanced, a resuable sterilizing and disinfecting solution, is likely to be ineffective for its intended use because testing found it failed testing for sporicidal use.	accessdata.fda.gov

Compare with other makers

Updated December 7, 2005. 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.