Devices

Device Recall Breeze SelfAdhesive Resin Cement

Model / Serial
Syringe Lot Number: 3558203 Kit Lot Numbers: 3581367, 3564511, 3538478
Product Classification
Dental Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - USA (nationwide) and the countries of: Austria, Belgium, Canada, Cypress, Greece, Germany, Italy, Jordon, Poland, Romania, Turkey and Vietnam.
Product Description
Breeze Self-Adhesive Resin Cement, Part Number: N97A, || Product Usage: The intended use of this device is for cementation of porcelain, resin, and metalbased inlays, onlays, crowns, bridges and posts. The material is not recommended for use on veneer restorations.
Manufacturer
Kerr/pentron Dba Kerr Corporation And Pentron Clinical
1 Event
- Recall of Device Recall Breeze SelfAdhesive Resin Cement

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

One device with a similar name

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Device Recall Breeze SelfAdhesive Resin Cement

Model / Serial
Lot # 200466
Product Classification
Dental Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - Nationwide (USA) and the countries of Vietnam, Jordan,Turkey, and Italy.
Product Description
Breeze Self-Adhesive Resin Cement, part number: N97F. The intended use is for cementation of porcelain, resin, and metal-based inlays, onlays, crowns, bridges, and posts.
Manufacturer
Kerr Corporation

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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