# K992385: Orthopantomograph OP100D

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentarium Corp.
- Decided: Sep 28, 1999 after 74 days
- Product code: MUH (System, X-Ray, Extraoral Source, Digital)
- Device class: 2
- Regulation: 21 CFR 872.1800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
14 later devices descend from it; 3 cite it directly.
0 of 15 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
- K043612: Orthopantomograph OP200, OP200D, and Orthoceph OC200, OC200D (2005), 10 descendants of its own
- K141700: Papaya Plus, Digital Extraoral Source X-Ray System (2014), 6 descendants of its own
- K150354: PAPAYA 3D Plus (2015), 4 descendants of its own
- K200469: PAPAYA 3D Premium & PAPAYA 3D Premium Plus (2020), 1 descendant of its own
- K181297: DENTIOIII series (DENTIOIII, DENTIOIII-S) (2018), 1 descendant of its own

## Indications for use
Orthopantomograph® OP100D is intended to be used for producing diagnostic x-ray radiographs of dentition, TM-joints and other oral structures.

Source page: https://510kreport.com/device/K992385
Methodology: https://510kreport.com/methodology