# K991961: 3M LVR System

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: Aug 9, 1999 after 60 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- 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. The FDA summary names its predicate without a number.
- (no number) DYRACT® FLOW, DENTSPLY Caulk: named in the summary without a submission number
- (no number) AELITEFLO™, Bisco Dental Products: named in the summary without a submission number
- (no number) Revolution Flowable Paste Product, Kerr Corp.: named in the summary without a submission number
- (no number) TETRIC® FLOW Flowable Ceromer, Ivoclar Vivadent: named in the summary without a submission number

## Recalls of this device
- Feb 12, 2007 · Not classified · Z-0800-2007: Cement in 3M ESPE RelyX Veneer Cement Refill A3 Shade syringes, may not cure to the degree expected.

## Indications for use
This device is indicated for: Base/liner under direct restorations Pit and fissure sealant Veneer Cementation Undercut blockout Restoration of minimal, shallow, Class V preparations Restoration of minimally invasive cavity preparations, including air abrasion and tunnel preparations Repair of small defects in composite and ceramic indirect restorations including veneers, inlays, onlays, crowns and bridges Repair of small marginal defects in direct restorations Repair of acrylic temporary marginal defects

Source page: https://510kreport.com/device/K991961
Methodology: https://510kreport.com/methodology