510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K892882Substantially Equivalent

Dental Sani-Sleeve Sterile 100Mm X 2200Mm #1102

Nieusma R & D, Inc., Warren MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K892882 is the FDA 510(k) clearance record for DENTAL SANI-SLEEVE STERILE 100MM X 2200MM #1102, a class I device, cleared for Nieusma R & D, Inc. on under FDA product code EHZ (Evacuator, Oral Cavity). FDA records list 3 510(k) clearances for Nieusma R & D, Inc., from to . As of , FDA records show no recalls naming K892882.

Clearance record

Decision date
Received
(78 days to decision)
Product code
EHZ Evacuator, Oral Cavity
Regulation
21 CFR 872.6640
Device class
Class I
Review panel
Dental
Applicant
Nieusma R & D, Inc. 13658 Hanford Ct., Warren MI
Third party review
No

Clearances, product code EHZ

Trailing 12 months

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

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