510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K925629Substantially Equivalent

Accessory to Improved Dental Operating Light

Den-Tal-Ez Mfg Co., Inc., Lancaster PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K925629 is the FDA 510(k) clearance record for ACCESSORY TO IMPROVED DENTAL OPERATING LIGHT, a class I device, cleared for Den-Tal-Ez Mfg Co., Inc. on under FDA product code EAZ (Light, Operating, Dental). FDA records list 7 510(k) clearances for Den-Tal-Ez Mfg Co., Inc., from to . As of , FDA records show no recalls naming K925629.

Clearance record

Decision date
Received
(382 days to decision)
Product code
EAZ Light, Operating, Dental
Regulation
21 CFR 872.4630
Device class
Class I
Review panel
Dental
Applicant
Den-Tal-Ez Mfg Co., Inc. 1816 Colonial Village Ln., Lancaster PA
510(k) summary
Summary
Third party review
No

Clearances, product code EAZ

Trailing 12 months

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

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