# K994211: Acucam Intraoral Camera Sheaths, Models 023545, 601111, 300407, 601285

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: Feb 4, 2000 after 52 days
- Product code: KKX (Drape, Surgical, Antimicrobial)
- Device class: 2
- Regulation: 21 CFR 878.4370
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K871465 (1987). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983406: Sanitherm Oral Disposable Thermometer Sheaths for Mercury Thermometer, Senitherm Oral Disposable Thermometer Sheaths for, Banta Healthcare Group, Ltd. (1998) Summary page 3.

## Indications for use
The AcuCam® Intraoral Camera Sheath is a single-use device intended for use with the various intraoral camera systems to prevent contamination of the camera handpiece with saliva and other bodily fluids.

Source page: https://510kreport.com/device/K994211
Methodology: https://510kreport.com/methodology