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PASCAL COMPANY, INC.

United States·US-MF-000032036

Last updated May 24, 2026

Information

Country: United States
Address: 2929 Northup Way, Bellevue, United States
Website: www.pascaldental.com/
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +18004268051
PRRC Contact: Alexia Petropoulos
EUDAMED SRN: US-MF-000032036
FDA FEI Number: —
DUNS Number: 009260217

Catalogue (161)

Page 3 of 4

Device	Model / Reference	Registries	Class	Status
Oratip Adapter	24080	EUDAMEDFDA UDI	Class I	Active
Disposable Foam Fluoride Tray	23700	EUDAMEDFDA UDI	Class I	Active
Retrax 00	07897	EUDAMEDFDA UDI	Class I	Active
MicroGrip Pro	26165	EUDAMED	Class I	Active
R-101	26101	EUDAMEDFDA UDI	Class I	Active
Siltrax Plain 0	07400	EUDAMEDFDA UDI	Class I	Active
Retrax 2	07920	EUDAMEDFDA UDI	Class I	Active
C-Plugger	26150	EUDAMED	Class I	Active
Siltrax Plain 2	07420	EUDAMEDFDA UDI	Class I	Active
Knittrax 00	07570	EUDAMEDFDA UDI	Class I	Active
R-EX Cord Remover	26160	EUDAMED	Class I	Active
Retrax Gel AS Clear Pro Pack	16840	EUDAMEDFDA UDI	Class I	Active
R-101, Standard	26100	EUDAMEDFDA UDI	Class I	Active
Tap & Slide	35697	EUDAMED	Class I	Active
R-55	26131	EUDAMEDFDA UDI	Class I	Active
Pt-55	26135	EUDAMEDFDA UDI	Class I	Active
Siltrax Plain 1	07410	EUDAMEDFDA UDI	Class I	Active
Pascord 1	07610	EUDAMEDFDA UDI	Class I	Active
Citrizyme, 50 Packet Bag	15260	EUDAMEDFDA UDI	Class I	Active
Knittrax Plain	07569	EUDAMEDFDA UDI	Class I	Active
Occlude Green, 23g	05300	EUDAMEDFDA UDI	Class I	Active
Isolator Disposable Cotton Roll Holder, 100 pack	18600	EUDAMEDFDA UDI	Class I	Active
Oratip III	24250	EUDAMEDFDA UDI	Class I	Active
R-11, Standard	26110	EUDAMEDFDA UDI	Class I	Active
Knittrax 0	07575	EUDAMEDFDA UDI	Class I	Active
Oratip I Kit	24105	EUDAMEDFDA UDI	Class I	Active
Bur Tray	35695	EUDAMED	Class I	Active
Oratip II Kit	24205	EUDAMEDFDA UDI	Class I	Active
Kois Packer DR-1	26225	EUDAMEDFDA UDI	Class I	Active
Initial Pack Siltrax	07000	EUDAMED	Class I	Active
Retrax Tweezer	26170	EUDAMEDFDA UDI	Class I	Active
Retrax Pellets	12400	EUDAMEDFDA UDI	Class I	Active
Disposable Foam Fluoride Tray (Large)	23710	EUDAMEDFDA UDI	Class I	Active
Retrax BK-1 Probe	26230	EUDAMEDFDA UDI	Class I	Active
Isolator Disposable Cotton Roll Holder 50 Pack	28100	EUDAMEDFDA UDI	Class I	Active
R-11	26111	EUDAMEDFDA UDI	Class I	Active
Nanobyte	26300	EUDAMEDFDA UDI	Class I	Active
Promark Forceps	26400	EUDAMEDFDA UDI	Class I	Active
Occlude Red, 23g	05320	EUDAMEDFDA UDI	Class I	Active
Retrax Gel AS 30g Jar	15510	EUDAMEDFDA UDI	Class I	Active
EU Retrax Gel AS Pro Pack	16540	EUDAMEDFDA UDI	Class I	Active
R-55, Standard	26130	EUDAMEDFDA UDI	Class I	Active
EU Retrax Gel AS Micropoint Kits	16505	EUDAMEDFDA UDI	Class I	Active
R-50, Standard	26120	EUDAMEDFDA UDI	Class I	Active
Pascord 0	07600	EUDAMEDFDA UDI	Class I	Active
Pick Pack	26210	EUDAMEDFDA UDI	Class I	Active
Retrax Cord Cutter	26440	EUDAMEDFDA UDI	Class I	Active
Occlude Disposable Tips	05400	EUDAMED	Class I	Active
Retrax FS Solution	15640	EUDAMED	Class I	Active
Retrax Gel FS Pro Pack	16740	EUDAMEDFDA UDI	Class I	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Aug 9, 2005	Z-1588-05	—	terminated	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.