Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011632

FEI Number

3011632

Entity Name

Pascal International, Inc.

City/State/Country

Bellevue, WA, US

Establishment Address

2929 Northup Way, Bellevue, WA 98004, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Pascal International (Owner Number: 3011632)

Owner / Operator Contact Address

2929 Northup Way, Bellevue, WA 98004, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Retrax System Mirror OCCLUDE HYDENT HYDENT STICKS C-IPC/Off Angle Composite Placing R-101 PACKING INSTRUMENT R-11 R-11 PACKING INSTRUMENT 101 R-55 C-IPC Composite Placing Instrument , R-50 C-Plugger Composite Placing Instrum Get Packed Kois KR Series BK Probe Contra Angle Prophy Angle PDP Foam Fluoride Tray Juciy Tray Juicy Tray Animal Pals PROMARK FORCEPS Retrax Tweezer NanoByte R-50 Retraction Packing Instrument Retrax Cord Cutter Guyer 7A Retraction Packing Instr Black Retrax System R-101 Black Retrax System R-11 PT-55 Retraction Packing Instrument Black Retrax System R-55 Retrax Mirror Pick Pack Black Retrax System R-50 R-EX Retraction Explorer Retrax System Locking Tweezer MicroGrip Pro Multi-use Instrument R-55A Retraction Packing Instrument R-101 Retraction Packing Instrument R-11 Retraction Packing Instrument Pick Pack Forte R-55 Retraction Packing Instrument Retrax System Tweezer Retrax FS Solution KNITTRAX Racellet Pellets Gel Cord Clear SILTRAX AS Stat Gel RACORD Plus PASCORD Retrax Gel AS Clear Epidri Pellets Retrax AC Solution SILTRAX EPI SILTRAX PLAIN Retrax Pellets RACORD Retrax Gel FS Gel Cord RETRAX Retrax Gel AS RACORD TWO SILTRAX PLUS RETRAX PELLETS RETRAX SOLUTION ProPak Citrizyme Fluorilaq Fluorilaq Squeeze Fluorilaq Unit Dose Banicide Advanced Fluorilaq Varnish Brush PDP Applicator MicroBend Applicator ORATIP Get Sculpted Wax Carving Set

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2021-04-13
EFH	Paper, Articulation	Dental	Class 1	872.6140	1992-07-28
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	1992-07-28
EHK	Cup, Prophylaxis	Dental	Class 1	872.6290	1983-09-27
KMT	Tray, Fluoride, Disposable	Dental	Class 1	872.6870	2008-06-10
EFK	Forceps, Articulation Paper	Dental	Class 1	872.4565	1992-07-28
EIF	Accessories, Retractor, Dental	Dental	Class 1	872.4565	2001-04-29
MVL	Cord, Retraction	Unknown	Class U	N/A	2006-08-21
FLG	Cleaner, Ultrasonic, Medical Instrument	General Hospital	Class 1	880.6150	2023-10-13
LBH	Varnish, Cavity	Dental	Class 2	872.3260	2007-11-28
MED	Sterilant, Medical Devices	General Hospital	Class 2	880.6885	2007-11-28
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2009-10-28
EHZ	Evacuator, Oral Cavity	Dental	Class 1	872.6640	1992-07-28
EIK	Carver, Wax, Dental	Dental	Class 1	872.4565	2024-05-14

Official Correspondent

Elizabeth Williams

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Pascal International

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K033295	Novamin Technology, Inc.	BUTLER NUCARE ROOT CONDITIONER WITH NOVAMIN	2003-10-28
K033381	Discus Dental, Inc.	DISCHEM CHEMICAL PROPORTIONING & DISPENSING SYSTEM FOR USE WITH CETYLCIDE-G CONCENTRATE AND DILUENT, AQUARIUS MODEL	2004-01-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2025	Young Dental Manufacturing I, LLC	1	BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.

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9615399	DIADENT GROUP INTL., INC.	Vancouver British Columbia, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011632. Last updated year: 2026. Please use registration number 3011632 when referencing this establishment in official correspondence.