Devices

Device Recall 37 Etching Gel5ml syringe

Model / Serial
all lots of products labeled as 37% Phosphoric Acid Etching Gel produced since April 2007
Product Classification
Dental Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution: USA (nationwide) and countries of: Armenia, Austria, Australia, Antigua & Barbuda, Barbados, Belarus, Bulgaria, Canada, Czech Republic, Croatia, Cyprus, Ecuador, El Salvador, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Kenya, Latvia, Lebanon, Malaysia, Mexico, Morocco, Netherlands, Poland, Romania, Russia, St. Vincent & Grenadine, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, UAE, Ukraine, UK, and Vietnam.
Product Description
37% Etching Gel-5ml syringe, part #N01IB || The intended use of these devices is to etch tooth dentin/enamel in order to prepare the tooth surface prior to the application of a bonding agent.
Manufacturer
Kerr/pentron Dba Kerr Corporation And Pentron Clinical
1 Event
- Recall of Device Recall 37 Etching Gel5ml syringe

Manufacturer

Kerr/pentron Dba Kerr Corporation And Pentron Clinical

Manufacturer Address
Kerr/pentron Dba Kerr Corporation And Pentron Clinical, 1717 W. Collins Ave, Orange CA 92867
Manufacturer Parent Company (2017)
Danaher Corporation
Source
USFDA

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