510(k) · Cleared
ClearedDentronix DDS 7000 Rapid Dry Heat Sterilizer Sterilization System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coltene/Whaledent, Inc. · KMH Sterilizer, Dry Heat
Cleared on Aug 4, 2005 as substantially equivalent to K880322 (Dentronix, Inc., 1988) after a 43-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- Aug 4, 2005
- Review
- 43 days
- Class
- Class II
- Product code
- KMH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K880322 (1988). No later device cites it as a predicate yet.
- Root · 1 generation backK880322 Dentronix DDS 5000 Dry Heat Sterilization SystemDentronix, Inc. · 1988
- This deviceK051660 Dentronix DDS 7000 Rapid Dry Heat Sterilizer Sterilization SystemColtene/Whaledent, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K880322 | Dentronix DDS 5000 Dry Heat Sterilization System | Dentronix, Inc. | 1988 | — |
| 0 (this device) | K051660 | Dentronix DDS 7000 Rapid Dry Heat Sterilizer Sterilization System | Coltene/Whaledent, Inc. | 2005 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KMH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K880322 | Dentronix DDS 5000 Dry Heat Sterilization SystemSummary page 3…e the Dentronix DDS 5000 Dry Heat Sterilization System, referred to as the "DDS 5000" for the remainder of this document, legally marketed per 5 10(k) K880322- The DDS 7000 utilizes the same accessories used by the predicate device. General The DOS 7000, like the D… | 1988 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All KMH devicesKMH Sterilizer, Dry Heat: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KMH
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · KMH
Too few KMH 510(k)s in any year since 2007 to give a median.
Recalls per year · KMH
No recall names KMH since 2007.
Adverse event reports per year · KMH
No MAUDE report names KMH since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (376 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K051660 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051660: Dentronix DDS 7000 Rapid Dry Heat Sterilizer Sterilization System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051660
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026