Devices

Neodent

Model / Serial
Lot Number: 800115427
Product Classification
Dental Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide Distribution including AZ, CA, NY, and MA.
Product Description
Neodent Titamax WS Cortical Implant ¿4.0 x 5 mm || (Endosseous dental implant) || Article Number: 109.604 || Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. Dental implants are for single-stage or two-stage surgery. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function
Manufacturer
Instradent USA, Inc.
1 Event
- Recall of Neodent

Manufacturer

Instradent USA, Inc.

Manufacturer Address
Instradent USA, Inc., 60 Minuteman Rd, Andover MA 01810-1008
Manufacturer Parent Company (2017)
Straumann Holding AG
Source
USFDA

One device with a similar name

Learn more about the data here

Device Recall NEODENT CM Intraoral Scanbody

Model / Serial
Lot Numbers: 800.214.016, 800.217.067, 56.390, 63.224, 71.065, 71.066, 71.067, 71.068, 71.069, and 71.070.
Product Classification
Dental Devices
Device Class
1
Implanted device?
No
Distribution
Distributed to the states of: NJ, TX, NV, CA, PA, AZ, and IL.
Product Description
NEODENT CM Intraoral Scanbody, Article Number: 108.139
Manufacturer
Instradent USA, Inc.

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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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