# K961822: Wet-Prep

- Pathway: 510(k) (Traditional)
- Applicant: Bisco, Inc.
- Decided: Jun 11, 1996 after 32 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
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) Bisco DENTIN CONDITIONER™: named in the summary without a submission number
- (no number) Hema-Benz™: named in the summary without a submission number

## Indications for use
VET-PREP is used to re-wet dried dentin following acid etching and drying of the prepared cavity. Following etching the dentist typically air dries the etched enamel to check that a chalky-white appearance is present indicating that etching has occurred. At this point the dentin and enamel are too dry for effective penetration of subsequently applied primers. Hydrophilic primers will not effectively penetrate the dried collapsed collagen layer. If the primer is unable to penetrate through collapsed collagen an effective seal will not occur and post-operative sensitivity is likely to result. If WET-PREP is applied prior to application of the primers, it will effectively re-wet the collapsed collagen and allow for penetration of the hydrophilic primers through the moist collagen network. Enhancement of penetration of primers will improve the seal the restorative material makes with the prepared tooth. Since it is well known that microleakage is the predominant reason for post-operative sensitivity it is reasonable to assume an increase in sensitivity ought to result from the use of these products.

Source page: https://510kreport.com/device/K961822
Methodology: https://510kreport.com/methodology