Device product
The brand name of the device is AlgiNot, a dental impression material. Product Part Numbers AlgiNot Intra Kit 34683 AlgiNot Volume Refills 34682 Lot Number 1-1017 AlgiNot is a Class II Medical Device. The device listing number this product is 0136496 and the establishment registration number for Kerr Corporation is 1815757. Intended as an alternative to traditional alginate materials.
Z-0268-2013
Product summary
- Firm
- Kerr Corporation
- Event
- Event 63297
- Status
- Terminated
- Classification
- Class II
- Quantity
- 45 kits and 87 refills
- Official record key
device-enforcement:Z-0268-2013
Official wording
Reason: The firm recalled the product because it may cure harder than expected within the shelf life, which could result in a material that may be more difficult to remove. Use of this product on patients with loose teeth may result in possible tooth fracture or tooth extraction.
Code information: ¿Product Part Numbers Lot Number AlgiNot Intra Kit 34683 1-1017 AlgiNot Volume Refills 34682 1-1017
Distribution pattern: Worldwide Distribution-USA (nationwide) and the countries of Canada, Europe, and Australia.
Derived failure modes
-
Unknown
The firm recalled the product because it may cure harder than expected within the shelf life, which could result in a material that may be more difficult to remove. Use of this product on patients with loose teeth may result in possible tooth fracture or tooth extraction.