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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 2 of 4

Device	Model / Reference	Registries	Class	Status
Racord Two Retraction Cord 8/0	07800	FDA UDI	U	Unknown
Radent Prophy Paste Coarse Grit Mint Flavor Jar	13605	FDA UDI	Class I	Active
Retrax Gel AS Jar	15510	FDA UDI	U	Active
Prophy Angle - Screw On	22100	FDA UDI	Class I	Active
Fluorilaq Mint (10mL) Tube	10406	FDA UDI	Class II	Active
SilTrax Plus Retraction Cord 8/0	07300	FDA UDI	U	Active
EU Retrax Gel FS ProPack Sample	88101	FDA UDI	U	Active
SilTrax Plus Retraction Cord 9/1	07310	FDA UDI	U	Active
EU Retrax Gel AS ProPack Sample	88102	FDA UDI	U	Active
Radent Prophy Paste Coarse Grit Bubblegum Flavor Jar	13655	FDA UDI	Class I	Active
Radent Prophy Paste Cups, Coarst Grit, Mint Flavor	13205	FDA UDI	Class I	Active
SilTrax Plus Retraction Cord 10/2	07320	FDA UDI	U	Active
Kois Kr-2 Packer	26226	FDA UDI	Class I	Active
SilTrax EPI Retraction Cord 10/2	07220	FDA UDI	U	Active
Retrax Gel FS ProPack SAMPLE	88103	FDA UDI	U	Active
Banicide Plus Sterilizing and Disinfecting Solution	15200	FDA UDI	Class II	Active
Retrax Solution 40 mL	15610	FDA UDI	U	Active
Isolator Disposable Cotton Roll Holder 10 Pack	28110	EUDAMEDFDA UDI	Class I	Active
Hydent Denture Indicator Aerosol Paste	05100	EUDAMEDFDA UDI	Class I	Active
Pascord 2	07620	EUDAMEDFDA UDI	Class I	Active
Pascord 00	07597	EUDAMEDFDA UDI	Class I	Active
Retrax AS Solution 15mL	16600	EUDAMED	Class I	Active
Get Packed	26220	EUDAMEDFDA UDI	Class I	Active
Occlude Green Jumbo, 75g	05305	EUDAMEDFDA UDI	Class I	Active
Jewel Scaler	26180	EUDAMED	Class I	Active
Knittrax 2	07585	EUDAMEDFDA UDI	Class I	Active
Guyer 7A	26141	EUDAMEDFDA UDI	Class I	Active
C-IPC Off Angle	26155	EUDAMED	Class I	Active
Knittrax 1	07580	EUDAMEDFDA UDI	Class I	Active
EU Siltrax AS 0	08100	EUDAMED	Class I	Active
Citrizyme, 300g Pouch	15250	EUDAMEDFDA UDI	Class I	Active
Oratip II	24200	EUDAMEDFDA UDI	Class I	Active
Retrax FS Solution	18520	EUDAMED	Class I	Active
Citrizyme, 900g Pouch	15270	EUDAMEDFDA UDI	Class I	Active
Zircon-F Prophylaxis Paste	K040988	FDA 510(k)	Class I	Active
Blo2x Oxygen Blocker	K102526	FDA 510(k)	Class II	Active
Banicide Liquid Chemical Sterilant/High-Level Disinfectant	K012889	FDA 510(k)	Class II	Active
Hydent	K911259	FDA 510(k)	Class I	Active
Occlude	K912632	FDA 510(k)	Class I	Active
Fluorilaq	K030488	FDA 510(k)	Class II	Active
Radent Prophy Paste	K040661	FDA 510(k)	Class I	Active
Fluorilaq Sodium Fluoride Cavity Varnish	K090597	FDA 510(k)	Class II	Active
EU Siltrax AS 00	08097	EUDAMED	Class I	Active
Hydent Sticks	05110	EUDAMEDFDA UDI	Class I	Active
EU Siltrax AS 2	08120	EUDAMED	Class I	Active
R-55a	26140	EUDAMEDFDA UDI	Class I	Active
Siltrax Plain 00	07397	EUDAMEDFDA UDI	Class I	Active
C-Ipc	26145	EUDAMED	Class I	Active
EU Siltrax AS 1	08110	EUDAMED	Class I	Active
Retrax 0	07900	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.