# K140125: New Stetic Dental Amalgam Alloy

- Pathway: 510(k) (Traditional)
- Applicant: New Stetic
- Decided: Apr 29, 2014 after 103 days
- Product code: OIV (Dental Amalgam)
- Device class: 2
- Regulation: 21 CFR 872.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K802967 (1980). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940675: Sybraloy, Sybron Dental Specialties, Inc. (1994) Summary page 2.
- K820181: Sybron/Kerr Contour, Sybron Corp. (1982) Summary page 2.
- K802967: Dispersalloy-Dispersed Phase Alloy Self-, Johnson & Johnson Professionals, Inc. (1980). Our reading of the summary gave K820967, FDA’s number for Biopsy Forceps W/Alligator Type Cups (Mill-Rose Laboratory). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Dispersalloy-Dispersed Phase Alloy”. Summary page 3.

## Indications for use
New Stetic NU Alloy DP 40, NU Alloy DP, NU Alloy DP Active and Micronic Dental Amalgam Alloys are commonly used as a filling material for restoring the morphology and function of posterior teeth (cavities class I and 11in molars and premolars), when these have lost their structure due to injuries such as cavities or fractures.

Source page: https://510kreport.com/device/K140125
Methodology: https://510kreport.com/methodology