# K051660: Dentronix DDS 7000 Rapid Dry Heat Sterilizer Sterilization System

- Pathway: 510(k) (Traditional)
- Applicant: Coltene/Whaledent, Inc.
- Decided: Aug 4, 2005 after 43 days
- Product code: KMH (Sterilizer, Dry Heat)
- Device class: 2
- Regulation: 21 CFR 880.6870
- 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 K880322 (1988). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K880322: Dentronix DDS 5000 Dry Heat Sterilization System, Dentronix, Inc. (1988) Summary page 3.

## Indications for use
The DDS 7000 is a countertop convective dry heat sterilizer designed for use in Healthcare facilities for the sterilization' of un-bagged dental instruments that can withstand exposure temperatures up to 216°C (4200 F). There is a single software-controlled cycle that includes a warm-up and cool down phase in addition to the 3-minute sterilization (exposure) phase. Sterilize (exposure) starts when the RTD/control temperature reaches the operating temperature set point of 190°C (3740 F). Complete cycle times average 34-44 minutes and are load dependent. The DDS 7000 achieves optimum results by uniform load distribution utilizing a dedicated rack and tray system as detailed below. 1) Maximum recommended loads validated fortheDDS 7000-115 sterilizer: a) Maximum load for a four (4)-rack configuration is four (4) plier racks each holding nine (9) orthodontic pliers each for a total of thirty-six (36) pliers. Other maximum load configuration options are: 32 pliers on eight mini vertical racks; or 20 pliers and hand instruments on four Combo Racks -(OR)- b) Maximum load for a full tray configuration is one (1) Horizontal Tray each holding up to six (6) orthodontic pliers or up to (12) single-handle hand instruments. Other maximum load combinations include: (5) orthodontic pliers with up to (2) single-handle hand instruments; or (4) orthodontic pliers with up to (4) single-handle hand instruments; or (3) orthodontic pliers with up to (6) single-handle hand instruments; or (2) Orthodontic pliers with up to (8) single-handle hand instruments; or (1) Orthodontic pliers with up to (10) single-handle hand instruments. -(OR)- c) Maximum load for the one (1) half tray and two (2) racks is one (1) Half Tray holding three (3) Orthodontic pliers or six (6) single-handle hand instruments in combination with two (2) plier racks capable of holding nine (9) pliers each for a total of eighteen (18) pliers on plier racks. Other maximum load combinations include: (2) orthodontic pliers with up to (2) single-handle hand instruments in combination with two (2) plier racks capable of holding nine (9) pliers each for a total of eighteen (18) pliers on plier racks; or (1) orthodontic pliers with up to (4) single-handle hand instruments in combination with two (2) plier racks capable of holding nine (9) pliers each for a total of eighteen (18) pliers on plier racks.

Source page: https://510kreport.com/device/K051660
Methodology: https://510kreport.com/methodology