# K991509: Pro-Portion Cleaner/Disinfectant

- Pathway: 510(k) (Traditional)
- Applicant: Sultan Chemists, Inc.
- Decided: Jul 14, 1999 after 75 days
- Product code: LRJ (Disinfectant, Medical Devices)
- Device class: 1
- Regulation: 21 CFR 880.6890
- 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 no predicate by number.

## Indications for use
Pro-Portion is a general-purpose cleaner/disinfectant. Its use is restricted to a health care setting where low and intermediate level disinfection of hard, non-porous surfaces is required. It is intended to be used in a dental office as an instrument ultrasonic cleaning solution. In order to disinfect, a contact time of 10 minutes at 69°F / 20°C is required. This product may be used to pre-clean or decontaminate of critical or non- critical medical devices prior to sterilization. Must be followed by appropriate terminal sterilization or high-level disinfection process.

Source page: https://510kreport.com/device/K991509
Methodology: https://510kreport.com/methodology