510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN230035Unknown

DentalMonitoring

Dental Monitoring SAS, Paris, FR / Direct, Unknown
FDA source (opens on fda.gov)

DEN230035 is the FDA 510(k) clearance record for DentalMonitoring, a class II device, cleared for Dental Monitoring Sas on under FDA product code SBC (Dental Image Analyzer). FDA's definition for product code SBC reads: "A dental image analyzer is a prescription home use device that uses software intended to collect and analyze patient-specific, optical camera-based, intraoral images. The analyses are provided to dental health care professionals as an aid...". FDA records list one 510(k) clearance for Dental Monitoring Sas. As of , FDA records show no recalls naming DEN230035.

Clearance record

Decision date
Received
(379 days to decision)
Product code
SBC Dental Image Analyzer
Regulation
21 CFR 872.1770
Device class
Class II
Review panel
Dental
Applicant
Dental Monitoring Sas 75 Rue De Tocqueville, Paris, FR
Third party review
No

Clearances, product code SBC

Trailing 12 months

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

FDA records show no clearances under product code SBC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code SBC, 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