510(k) Report

510(k) · Cleared

Cleared

Belmont Quolis 5000 Series Dental Unit

K072273510(k) TraditionalCleared Dec 20, 2007127-day reviewClass I21 CFR 872.6640

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Takara Belmont USA, Inc. · NRD Unit, Operative Dental, Accessories

Cleared on Dec 20, 2007 as substantially equivalent to K000799 (Belmont Equipment Corp., 2000) after a 127-day review. Its family tree reaches back 1 generation to 2000.

Decided
Dec 20, 2007
Review
127 days
Class
Class I
Product code
NRD
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K000799 (2000). No later device cites it as a predicate yet.

K000799 · Belmont Unit, Model 2000 Series · Belmont Equipment Corp. · 200020002002200420062008
K000799 · Belmont Unit, Model 2000 Series · Belmont Equipment Corp. · 20000
  1. Root · 1 generation backK000799 Belmont Unit, Model 2000 SeriesBelmont Equipment Corp. · 2000
  2. This deviceK072273 Belmont Quolis 5000 Series Dental UnitTakara Belmont USA, Inc. · 2007
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K000799Belmont Unit, Model 2000 SeriesBelmont Equipment Corp.2000—
0 (this device)K072273Belmont Quolis 5000 Series Dental UnitTakara Belmont USA, Inc.2007—
FIG. 1 — Lineage of K072273, 2000–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 NRD? 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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K000799Belmont Unit, Model 2000 Series
Summary page 2
…the Belmont Dental Unit, Model 2000 series and Model 6000 series, as indicated in the Belmont 510k, Pre-market notification submission dated March 7, 2000, K000799. Comparison of QUOLIS 5000 dental unit and Belmont 2000 Series Dental Unit as presented in attachment 2 indicates t…
Belmont Equipment Corp.2000—

Also cleared against K000799: 1 other device →

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.
  • 1 other device also cites its predicate K000799.

How does its category compare?

All NRD devices

NRD Unit, Operative Dental, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · NRD

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NRD

Too few NRD 510(k)s in any year since 2007 to give a median.

Recalls per year · NRD

No recall names NRD since 2007.

Adverse event reports per year · NRD

1in 2022

2011: 12022: 1
2007high 1 (2011) · low 0 (2007)2025

MAUDE reports naming product code NRD, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20080—00
20090—00
20100—00
20110—01
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—01
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The Unit and Accessories are intended for the Dentists, Hygienists, and Dental assistants for traditional and normal patient treatment procedures in the dental office.

Indications for use as stated in the FDA summary.

Also cleared against K000799

1 other device cites the same predicate.

  • K152100Evogue Dental UnitTakara Belmont Corporation · 2016

More from Takara Belmont USA, Inc.

6 FDA decisions under this applicant name. See the company

  • K102456Intraoral Belsensor GoldTakara Belmont USA, Inc. · 2011
  • K062529Belmax CM Model X168Takara Belmont USA, Inc. · 2006
  • K041834Adr Plus Ssxi Imaging Device for X-Ray Systems Such as X-Caliber, X-Caliber CM, Ana-Bel and Ana-Bel CMTakara Belmont USA, Inc. · 2004
  • K042260Phot-X II, Model 303Takara Belmont USA, Inc. · 2004
  • K040748Ana-Bel, Model 087D and Ana-Bel CM, Model 187-CMTakara Belmont USA, Inc. · 2004

Recent decisions in NRD

The NRD category page

  • K042266AcclaimAir Techniques, Inc. · 2004

https://510kreport.com/device/K072273 · printed Nov 6, 2026

Cite this page

510(k) Report. “K072273: Belmont Quolis 5000 Series Dental Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072273

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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