510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K072273Substantially Equivalent

Belmont Quolis 5000 Series Dental Unit

Takara Belmont USA, Inc., West Cadwell NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K072273 is the FDA 510(k) clearance record for BELMONT QUOLIS 5000 SERIES DENTAL UNIT, a class I device, cleared for Takara Belmont USA, Inc. on under FDA product code NRD (Unit, Operative Dental, Accessories). FDA's definition for product code NRD reads: "Air compressor and vacuum unit that are connected to dental operative unit to provide compressed air and vacuum capability to power and drive other dental devices, which are attached to the dental operative unit". FDA records list 6 510(k) clearances for Takara Belmont USA, Inc., from to . As of , FDA records show no recalls naming K072273.

Clearance record

Decision date
Received
(127 days to decision)
Product code
NRD Unit, Operative Dental, Accessories
Regulation
21 CFR 872.6640
Device class
Class I
Review panel
Dental
Applicant
Takara Belmont USA, Inc. 1129 Bloomfield Ave., West Cadwell NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NRD

Trailing 12 months

FDA records hold no clearances under product code NRD in the trailing twelve months.

FDA records show no clearances under product code NRD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NRD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260