# K951663: Tytin R

- Pathway: 510(k) (Traditional)
- Applicant: Kerr Corporation (Danbury)
- Decided: Jun 6, 1995 after 57 days
- Product code: EJJ (Alloy, Amalgam)
- Device class: 2
- Regulation: 21 CFR 872.3070
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- May 29, 2014 · Class II · Z-1788-2014: Kerr Corporation is recalling one (1) lot of Tytin Regular Set ( Part Number 29948, Lot Number 3-1294), because it may set faster than specified in the Directions for Use.

Source page: https://510kreport.com/device/K951663
Methodology: https://510kreport.com/methodology