# K981647: 3M Dent II System

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: Aug 9, 1998 after 90 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 2 cite it directly.
0 of 12 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) 3M™ Z100™ Restorative: named in the summary without a submission number
- (no number) Prisma TPH™ Spectrum: named in the summary without a submission number
- (no number) XRV™ Herculite®: named in the summary without a submission number
- (no number) Alert™: named in the summary without a submission number
- (no number) SureFil™: named in the summary without a submission number

## Most influential descendants
- K120453: Filtek Bulk Fill Flowable Restorative (2012), 8 descendants of its own
- K182714: Novidia Bulk Fill Flow Composite (2019), 2 descendants of its own
- K201010: Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite (2020), 1 descendant of its own
- K151094: Mosaic Universal Composite (2015), 1 descendant of its own
- K253513: MultiMatch Flow Chameleon AntiMicrobial Composite (2025), 0 descendants of its own

## Indications for use
Indications: * Direct anterior restorations including: - Class III, IV, V, and VI - Veneers - Incisal edge repair * Direct posterior restorations including: - Class I or II - Sandwich technique with glass ionomer resin material - Cusp Buildups * Core Buildups * Splinting * Indirect anterior and posterior restoration including: - Inlays - Onlays - Veneers

Source page: https://510kreport.com/device/K981647
Methodology: https://510kreport.com/methodology