Pascal Company, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED SRN US-MF-000032036
Pascal Company, Inc. is a medical device manufacturer based in the United States, with 170 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (EU Class I; FDA Unclassified, Class I and Class II) and 1 FDA recall as of 15 Nov 2026.
- Devices
- 170
- Registrations
- EUDAMED
- FDA recalls
- 1
Registry facts
- Registries
- FDA GUDID 134
- EUDAMED 104
- FDA 510(k) 8
- Device classes
- EU Class I 97
- FDA Unclassified 39
- FDA Class I 23
- FDA Class II 11
- Top EMDN categories
- FDA recalls
- Sites and related companies
- Emergo Europe B.V. authorised representative
- Identifiers
- EUDAMED SRN US-MF-000032036
- DUNS 009260217
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA recalls
- Authorised rep.
- Emergo Europe B.V.NL
What Pascal Company, Inc. makes
Pascal Company, Inc. manufactures dental and oral care products, including non-medicated and medicated gingival retraction cords, retraction solutions, dental cavity varnishes, and dental disinfection agents. Their portfolio also covers dentifrice (toothpaste) in various flavors and grits, as well as tools like gingival retraction cord packing devices and pre-packaged retraction kits.
The company’s devices are classified as Class I, Class II, or unclassified (U) under regulatory frameworks, with listings in the EU’s EUDAMED database and the FDA’s Unique Device Identifier (UDI) system. The manufacturer is based in the United States.
Catalogue
Search and filter all 170 devicesShowing 1-50 of 170
Company details
- EUDAMED SRN
- US-MF-000032036
- DUNS number
- 009260217
- EUDAMED status
- Active
- EUDAMED registered name
- Pascal Company Inc.
- Registered address
- 2929 Northup Way, 98004, Bellevue, United States
- Website
- www.pascaldental.com/
- Phone
- +18004268051
- PRRC contact
- Alexia Petropoulos
FDA recalls
FDA recall records list 1 recall initiated by PASCAL COMPANY, INC., initiated on 2005-08-09. By recorded status: 1 terminated. The reasons filed fall into these groups: sterility or contamination. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2005
- 9 Aug 2005 Z-1588-05 Unclassified (pre-2012) 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.
Full distribution text
- 9 Aug 2005 Z-1588-05 Unclassified (pre-2012) 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.
Frequently asked questions
How many devices does PASCAL COMPANY, INC. have in the registry?
The registry currently lists 170 devices for PASCAL COMPANY, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list PASCAL COMPANY, INC.'s devices?
Among its 50 most recently registered devices, PASCAL COMPANY, INC. has devices listed in EUDAMED (17 devices) and FDA GUDID (39 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do PASCAL COMPANY, INC.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for PASCAL COMPANY, INC.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for PASCAL COMPANY, INC.?
FDA recall records list 1 recall initiated by PASCAL COMPANY, INC., the most recent initiated on 9 Aug 2005. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from PASCAL COMPANY, INC. in the registry?
The most recently registered devices listed for PASCAL COMPANY, INC. include ProPak 000, Hydent, French, ProPak 01 and ProPak 00.