# K962979: S-53 Introral Dental System

- Pathway: 510(k) (Traditional)
- Applicant: Del Medical Systems Corp.
- Decided: Sep 25, 1996 after 56 days
- Product code: DZA (Drill, Dental, Intraoral)
- Device class: 1
- Regulation: 21 CFR 872.4130
- 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) Fuji Optical Systems-Dentacam: named in the summary without a submission number
- (no number) New Image-Accucam: named in the summary without a submission number
- (no number) IDT: named in the summary without a submission number
- (no number) Welch Allyn: named in the summary without a submission number
- (no number) Dentsply: named in the summary without a submission number
- (no number) Air Technologies: named in the summary without a submission number

Source page: https://510kreport.com/device/K962979
Methodology: https://510kreport.com/methodology