International Medical Devices Database

Manufacturer Address
Henry Schein, Inc., 135 Duryea Rd, Melville NY 11747
Manufacturer Parent Company (2017)
Henry Schein Inc
Source
USFDA
1 Event
- Recall of Device Recall Maxcem Elite

One device in the database

Device Recall Maxcem Elite

Model / Serial
Lot numbers 3285932 (exp. 01/2011), 3461229 (exp. 11/2011), 3566373 (exp. 05/2012) ; HSI number 123-7426
Product Classification
Dental Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution: USA (nationwide) and countries of: Bermuda, Martinique FWI, Nassau Bahamas, St Maarten NA, Australia, and South Africa.
Product Description
Maxcem Elite(TM) self-etch/self-adhesive resin cement, Refill Kit, net wt. 10 g, REF/Part # 33872, CLEAR --- Refill Kit Contents: 2 Syringes (5 g ea), 10 Automix tips (regular) 4:1, 10 Automix tips (wide) 4:1, 10 Intra-oral tips || Dental resin cement. Self-etch, self-adhesive resin cement. High bond strength without adhesive needed. Easy to clean up and can be used with all anterior and posterior ceramics, PFMs, and CAD/CAM materials. Color stable and aesthetic. Works with all substrates from opaque to translucent.

One manufacturer with a similar name

Learn more about the data here

Henry Schein, Inc.

Manufacturer Address
Henry Schein, Inc., 135 Duryea Road, Melville NY 11747
Source
USFDA

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Disclaimer

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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