510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K073483Substantially Equivalent

Sapphire O/e Oral Examination System

Den-Mat Holdings, LLC, Santa Maria CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K073483 is the FDA 510(k) clearance record for SAPPHIRE O/E ORAL EXAMINATION SYSTEM, a class II device, cleared for Den-Mat Holdings, LLC on under FDA product code NXV (Diagnostic Light, Soft Tissue Detector). FDA's definition for product code NXV reads: "To be used as an aid in the detection or visualization of abnormalities of intraoral soft tissue. An adjunct to traditional intraoral examination by incandescent light to enhance the visualization of oral mucosal abnormalities". FDA records list 10 510(k) clearances for Den-Mat Holdings, LLC, from to . As of , FDA records show no recalls naming K073483.

Clearance record

Decision date
Received
(114 days to decision)
Product code
NXV Diagnostic Light, Soft Tissue Detector
Regulation
21 CFR 872.6350
Device class
Class II
Review panel
Dental
Applicant
Den-Mat Holdings, LLC 2727 Skyway Dr., Santa Maria CA
510(k) summary
Statement
Third party review
No

Clearances, product code NXV

Trailing 12 months

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

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