# K071267: Periosrp Tooth Root Conditioner with Novamin

- Pathway: 510(k) (Special)
- Applicant: Novamin Technology, Inc.
- Decided: May 18, 2007 after 11 days
- Product code: LBH (Varnish, Cavity)
- Device class: 2
- Regulation: 21 CFR 872.3260
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K072342: Sultan Tooth Root Desensitizer (2007), 5 descendants of its own
- K082198: Durashield Plus (2008), 4 descendants of its own
- K090519: Vanish Varnish, 5% Sodium Fluoride Varnish, Model 12245, Vanish Varnish, 5% Fluoride Varnish, Model 12247 (2009), 3 descendants of its own
- K100540: Ascent F-Coat Model: 006-00097 (2010), 2 descendants of its own
- K103160: Nupro Model 13016901 (2011), 1 descendant of its own

## Indications for use
PerioSRPTM Tooth Root Conditioner with NovaMin® is a two-phase product intended for the rapid relief of hypersensitivity associated with exposed tooth root dentin. Studies have shown that PerioSRPTM Tooth Root Conditioner with NovaMin® is effective at occluding exposed dentinal tubules, which has been shown in the literature to be associated with a reduction in hypersensitivity.

Source page: https://510kreport.com/device/K071267
Methodology: https://510kreport.com/methodology