# K091705: Primer Plus

- Pathway: 510(k) (Traditional)
- Applicant: Bisco, Inc.
- Decided: Aug 28, 2009 after 79 days
- Product code: KLE (Agent, Tooth Bonding, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K931812 (1993). 22 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061906: Clearfil Ceramic Primer, Kuraray Medical, Inc. (2006) Summary page 1.

## Cited in the summary but kept off the family tree
- K081159: Harvard Medical Devices Blood Pressure Monitor, Model Hmbpm-004/Kinetik Branded BPM1 Series, Harvard Medical Devices, Ltd. (2008). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K131357: PEAK Z (2013), 0 descendants of its own

## Indications for use
Primer Plus is a universal restoration primer. The principle uses of the Primer Plus are: 1. Indirect restorations (such as composite, endodontic posts, metal/metal alloys, porcelain, zirconia, alumina, ceramics, and hybrid ceramics) 2. Intraoral repairs of fractured crowns and bridges (such as metals/metal alloys, porcelain, zirconia, alumina, ceramics, hybrid ceramics, or composite resin)

Source page: https://510kreport.com/device/K091705
Methodology: https://510kreport.com/methodology