# K973961: 3M Dent System II Plus

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: Dec 17, 1997 after 62 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.
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. The FDA summary names its predicate without a number.
- (no number) 3M™ Scotchbond™ Resin Cement: named in the summary without a submission number
- (no number) Bisco Resinomer™: named in the summary without a submission number
- (no number) Bisco Duolink™: named in the summary without a submission number

## Indications for use
This device is indicated for direct and indirect dental bonding applications.

Source page: https://510kreport.com/device/K973961
Methodology: https://510kreport.com/methodology