# K041335: PTM System

- Pathway: 510(k) (Special)
- Applicant: Dentsply International
- Decided: Jun 16, 2004 after 29 days
- Product code: EIH (Powder, Porcelain)
- Device class: 2
- Regulation: 21 CFR 872.6660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K940252 (1994). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940252: Finesse Porcelain System, Dentsply Intl. (1994) Summary page 1.

## Most influential descendants
- K071848: Ips Inline Pom System (2007), 3 descendants of its own
- K152103: IPS Style Ceram, IPS Style Ceram One, IPS Style Press (2016), 0 descendants of its own
- K123613: Synspar Advanced (2013), 0 descendants of its own
- K090434: Bece Press (2009), 0 descendants of its own

## Indications for use
Used to veneer metal substructures for fixed prosthodontics

Source page: https://510kreport.com/device/K041335
Methodology: https://510kreport.com/methodology