# K003658: Temp-Bond NE 2

- Pathway: 510(k) (Traditional)
- Applicant: Sybron Dental Specialties, Inc.
- Decided: Jan 4, 2001 after 37 days
- Product code: EMA (Cement, Dental)
- Device class: 2
- Regulation: 21 CFR 872.3275
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Temp-Bond NE: named in the summary without a submission number

## Most influential descendants
- K170330: 3M Protemp Cement Temporary Dental Cement (2017), 0 descendants of its own
- K151526: Zone, ZoneFree, Zone A1 (2015), 0 descendants of its own

## Indications for use
Temp-Bond NE is a non-eugenol temporary cement used for the cementation of temporary restorations.

Source page: https://510kreport.com/device/K003658
Methodology: https://510kreport.com/methodology