510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K884223Substantially Equivalent

Dental Lamp Handle Cover

Steri-Shield Products, Inc., Allentown PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K884223 is the FDA 510(k) clearance record for DENTAL LAMP HANDLE COVER, a class I device, cleared for Steri-Shield Products, Inc. on under FDA product code EAZ (Light, Operating, Dental). FDA records list 5 510(k) clearances for Steri-Shield Products, Inc. As of , FDA records show no recalls naming K884223.

Clearance record

Decision date
Received
(162 days to decision)
Product code
EAZ Light, Operating, Dental
Regulation
21 CFR 872.4630
Device class
Class I
Review panel
Dental
Applicant
Steri-Shield Products, Inc. 3620 Hamilton Blvd., Allentown PA
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